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1.
J Clin Psychopharmacol ; 34(3): 365-8, 2014 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-24717247

RESUMEN

The objective of this study was to determine whether the occurrence of discontinuation symptoms was equivalent for abrupt discontinuation versus 1-week taper to desvenlafaxine 25 mg/d after a 24-week treatment with desvenlafaxine 50 mg/d (administered as desvenlafaxine succinate) for major depressive disorder. Adult outpatients with major depressive disorder who completed the 24 weeks of open-label treatment with desvenlafaxine 50 mg/d were randomly assigned to no discontinuation (desvenlafaxine 50 mg/d), taper (desvenlafaxine 25 mg/d), or abrupt discontinuation (placebo) groups for the double-blind (DB) taper phase. The primary end point was Discontinuation-Emergent Signs and Symptoms (DESS) scale total score during the first 2 weeks of the DB phase. The null hypothesis that the absolute difference of greater than 2.5 in DESS scores between taper and abrupt discontinuation groups was tested by calculating the 95% 2-sided confidence interval on the mean difference between the 2 groups. Of the 480 patients enrolled in the open-label phase, 357 (≥1 postrandomization DESS record) were included in the primary analysis. Adjusted mean ± SE DESS scores were 4.1 ± 0.72 for no discontinuation (n = 72), 4.8 ± 0.54 for taper (n = 139), and 5.3 ± 0.52 for abrupt discontinuation (n = 146) groups. The difference in adjusted mean DESS total scores between the abrupt discontinuation and taper groups was 0.50 (95% confidence interval, -0.88 to 1.89) within the prespecified margin (±2.5) for equivalence. The number of patients who discontinued because of adverse events or discontinuation symptoms during the DB period was similar between the taper (2.8%) and abrupt discontinuation (2.1%) groups. These findings indicate that an abrupt discontinuation of desvenlafaxine 50 mg/d produces statistically equivalent DESS scores compared with the 1-week taper using 25 mg/d.


Asunto(s)
Antidepresivos/efectos adversos , Ciclohexanoles/efectos adversos , Trastorno Depresivo Mayor/tratamiento farmacológico , Síndrome de Abstinencia a Sustancias/epidemiología , Adulto , Antidepresivos/administración & dosificación , Antidepresivos/uso terapéutico , Ciclohexanoles/administración & dosificación , Ciclohexanoles/uso terapéutico , Succinato de Desvenlafaxina , Método Doble Ciego , Esquema de Medicación , Humanos , Pacientes Ambulatorios , Síndrome de Abstinencia a Sustancias/etiología
2.
J Nerv Ment Dis ; 201(4): 266-73, 2013 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-23538970

RESUMEN

The incidence of treatment-emergent sexual dysfunction in the acute and continuation phases of the prevention of recurrent episodes of depression with venlafaxine ER for two years (PREVENT) study was assessed. Adult outpatients with recurrent major depressive disorder were randomly assigned to receive venlafaxine extended release (ER; 75-300 mg/day) or fluoxetine (20-60 mg/day). Sexual dysfunction was assessed using items from the 17-item Hamilton Rating Scale for Depression (HAM-D(17)) and the Inventory of Depressive Symptomatology-Self-Report (IDS-SR). The baseline rates of sexual dysfunction based on the HAM-D(17) and IDS-SR items were 57.9% and 48.8%, respectively. The rates of new-onset sexual dysfunction for the venlafaxine ER-treated (44.8%, HAM-D(17); 38.4%, IDS-SR) and fluoxetine-treated patients (52.9%, HAM-D(17); 50.0%, IDS-SR) were similar; approximately 80% of the cases resolved during treatment. Treatment response was associated with lower rates of new-onset sexual dysfunction compared with nonresponse. The patients who remitted were the least likely to experience sexual dysfunction during antidepressant treatment.


Asunto(s)
Antidepresivos de Segunda Generación/efectos adversos , Antidepresivos de Segunda Generación/uso terapéutico , Ciclohexanoles/efectos adversos , Ciclohexanoles/uso terapéutico , Trastorno Depresivo Mayor/tratamiento farmacológico , Fluoxetina/efectos adversos , Fluoxetina/uso terapéutico , Disfunciones Sexuales Fisiológicas/inducido químicamente , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Trastorno Depresivo Mayor/diagnóstico , Trastorno Depresivo Mayor/psicología , Método Doble Ciego , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Inventario de Personalidad/estadística & datos numéricos , Psicometría , Prevención Secundaria , Disfunciones Sexuales Fisiológicas/diagnóstico , Disfunciones Sexuales Fisiológicas/psicología , Resultado del Tratamiento , Estados Unidos , Clorhidrato de Venlafaxina , Adulto Joven
3.
J Clin Psychopharmacol ; 30(4): 411-6, 2010 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-20631558

RESUMEN

The objective of this analysis was to assess the risk of increased suicidal thoughts and behavior (suicidality) with desvenlafaxine (administered as desvenlafaxine succinate) in patients with major depressive disorder (MDD). Data from 9 double-blind, 8-week studies in outpatients with MDD were analyzed retrospectively. Patients were randomly assigned to desvenlafaxine (n = 1834) or placebo (n = 1116). Adverse events (AEs) related to suicidality were identified by searching the AE database for text strings possibly related to suicidality; false positives were excluded. Narratives for each case were prepared and blinded for review. Events were classified according to the Columbia Classification Algorithm of Suicide Assessment. Odds ratios were calculated; chi tests were used to compare treatment groups. Occurrence of emerging or worsening suicidality, based on the 17-item Hamilton Rating Scale for Depression suicide item, was compared for desvenlafaxine and placebo using chi tests. In all, 17 (0.93%) of 1834 patients receiving desvenlafaxine and 8 (0.72%) of 1116 receiving placebo reported possible suicidality-related AEs. Events were relatively evenly distributed across treatment groups. One patient randomly assigned to desvenlafaxine treatment died of completed suicide during the on-therapy period. There were no significant differences between groups in the risk for any class of suicide-related events, including completed suicide or suicide attempt. Odds of emergence or worsening of suicidality 17-item (Hamilton Rating Scale for Depression suicide item) did not differ significantly between treatment groups. No evidence of a signal for increased suicidality was detected in adult patients treated with desvenlafaxine in short-term MDD trials. As suicidal events were extremely rare, a true increased risk cannot be ruled out.


Asunto(s)
Antidepresivos/efectos adversos , Ciclohexanoles/efectos adversos , Intento de Suicidio/psicología , Suicidio/psicología , Adolescente , Adulto , Anciano , Antidepresivos/uso terapéutico , Ciclohexanoles/uso terapéutico , Trastorno Depresivo Mayor/tratamiento farmacológico , Succinato de Desvenlafaxina , Método Doble Ciego , Humanos , Persona de Mediana Edad , Escalas de Valoración Psiquiátrica , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Retrospectivos , Riesgo , Adulto Joven
4.
CNS Spectr ; 15(3): 187-93, 2010 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-20414167

RESUMEN

BACKGROUND: This analysis evaluated the effects of the serotonin-norepinephrine reuptake inhibitor, desvenlafaxine (administered as desvenlafaxine succinate), on anxiety symptoms associated with depression. METHODS: Data were pooled from 9 randomized, placebo-controlled, double-blind, 8 week studies of desvenlafaxine (50-400 mg/day, fixed or flexible dose) in patients with major depressive disorder (MDD), without a primary anxiety diagnosis. Changes from baseline in scores on the anxiety/somatization factor of the 17-item Hamilton Rating Scale for Depression (HAM-D17) and on the Covi Anxiety Scale at the final evaluation (last observation carried forward) were compared between desvenlafaxine and placebo groups using analysis of covariance. RESULTS: In the overall data set (intent to treat n=2,913 [desvenlafaxine, n=1,805; placebo, n=1,108]), desvenlafaxine was associated with significantly greater reductions compared with placebo in scores on the HAM-D17 anxiety/somatization factor (-3.41 vs -2.92, P<.001) and Covi Anxiety Scale (-1.35 vs -1.04, P<.001). In the subset of fixed-dose studies, significant differences were observed for all dose groups on the HAM-D17 anxiety/somatization factor (P= or <.011), and for the 50, 100, and 200 mg/day dose groups on the Covi Anxiety Scale (all P= or <.015 vs placebo). CONCLUSIONS: Desvenlafaxine was associated with significantly greater improvement in anxiety symptoms compared with placebo in patients with MDD.


Asunto(s)
Antidepresivos/uso terapéutico , Ansiedad/tratamiento farmacológico , Ansiedad/etiología , Ciclohexanoles/uso terapéutico , Trastorno Depresivo Mayor/complicaciones , Adulto , Ensayos Clínicos Fase III como Asunto , Succinato de Desvenlafaxina , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pacientes Ambulatorios , Escalas de Valoración Psiquiátrica , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento
5.
J Psychiatr Res ; 43(3): 205-14, 2009 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-18586273

RESUMEN

OBJECTIVE: Patients (30-50%) with non-psychotic major depression will not respond despite an adequate trial of antidepressant medication. This study evaluated risperidone as an augmenting agent for patients who failed or only partially responded to an adequate trial of an antidepressant medication. METHOD: Ninety-seven patients with unipolar non-psychotic major depression who were not responsive to antidepressant monotherapy were randomized to risperidone (0.5-3mg/day) or placebo augmentation in a four-week, double-blind, placebo controlled treatment trial. The primary outcome measure was remission defined by a score of < or =10 on the Montgomery-Asberg Depression Rating Scale (MADRS). Secondary outcomes measures were the Hamilton Rating Scale for Depression, the Clinician Global Impression of Severity scale and the overall satisfaction item of the Quality of Life and Enjoyment Questionnaire. RESULTS: Subjects in both treatment groups improved significantly over time. The odds of remitting were significantly better for patients in the risperidone vs. placebo arm (OR=3.33, p=.011). At the end of 4 weeks of treatment 52% of the risperidone augmentation group remitted (MADRS< or =10) compared to 24% of the placebo augmentation group (CMH(1)=6.48, p=.011), but the two groups were converging. Patients in the risperidone group also reported significantly more improvement in quality-of-life than patients in the placebo group. There were no between-group differences in the number of adverse events reported, however, weight gain was significantly higher in the group receiving risperidone. CONCLUSION: Augmentation of an antidepressant with risperidone for patients with difficult-to-treat depression leads to more rapid response and a higher remission rate and better quality-of-life.


Asunto(s)
Antidepresivos/uso terapéutico , Trastorno Depresivo Mayor/tratamiento farmacológico , Risperidona/uso terapéutico , Adulto , Antidepresivos/administración & dosificación , Trastorno Depresivo Mayor/psicología , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Esquema de Medicación , Quimioterapia Combinada , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Satisfacción del Paciente , Placebos , Escalas de Valoración Psiquiátrica , Calidad de Vida , Inducción de Remisión/métodos , Risperidona/administración & dosificación , Índice de Severidad de la Enfermedad , Encuestas y Cuestionarios , Resultado del Tratamiento , Adulto Joven
6.
CNS Spectr ; 14(3): 144-54, 2009 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-19407711

RESUMEN

INTRODUCTION: To assess the efficacy of desvenlafaxine (administered as desvenlafaxine succinate) in outpatients with major depressive disorder. METHODS: A meta-analysis of individual patient data was performed on the complete set of registration trials (nine randomized, double-blind, placebo-controlled 8-week studies) of desvenlafaxine. Patients received fixed (50, 100, 200, or 400 mg/day; n=1,342) or flexible doses (100-400 mg/day; n=463) of desvenlafaxine or placebo (n=1,108). The primary efficacy variable was the 17-item Hamilton Rating Scale for Depression (HAM-D(17)); the primary intent to treat analyses used the last-observation-carried-forward method. RESULTS: Significantly greater improvement with desvenlafaxine versus placebo on the HAM-D(17) total score was observed for the full data set (difference in adjusted means: -1.9; P<.001), each fixed-dose group (all P<.001), and the flexible-dose group (P=.024). Overall rates of HAM-D1(17) response (> or =150% decrease from baseline score: 53% vs 41%) and remission (HAM-D(17) < or =7: 32% vs 23%) were significantly greater for desvenlafaxine versus placebo (all P<.001). Discontinuation rates due to adverse events increased with dose (4% to 18%; placebo: 3%). CONCLUSION: Desvenlafaxine demonstrated short-term efficacy for treating major depressive disorder across the range of doses studied. No evidence of greater efficacy was observed with doses >50 mg/day; a strong dose-response effect on tolerability was observed.


Asunto(s)
Antidepresivos de Segunda Generación/uso terapéutico , Ciclohexanoles/uso terapéutico , Trastorno Depresivo Mayor/tratamiento farmacológico , Adulto , Antidepresivos de Segunda Generación/administración & dosificación , Antidepresivos de Segunda Generación/efectos adversos , Ciclohexanoles/administración & dosificación , Ciclohexanoles/efectos adversos , Trastorno Depresivo Mayor/psicología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Escalas de Valoración Psiquiátrica , Ensayos Clínicos Controlados Aleatorios como Asunto , Clorhidrato de Venlafaxina
7.
Eur Arch Psychiatry Clin Neurosci ; 259(6): 329-39, 2009 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-19255709

RESUMEN

In this meta-analysis, we compare the relative efficacy of venlafaxine to selective serotonin reuptake inhibitors (SSRIs) in patients with major depressive disorder classified according to baseline disease severity. Data from 31 double-blind randomised clinical trials comparing venlafaxine and SSRIs (intent-to-treat n = 6,492) were pooled. For this secondary analysis, patients were stratified into groups based on baseline HAM-D(17) total score (>or=30, <30, >or=25, and <25). Remission rates (HAM-D(17) < 8) were analyzed for each subgroup using Fisher's exact test to compare treatment effects between venlafaxine and SSRIs; last observation carried forward (LOCF) and observed cases (OC) data were analyzed. The number needed to treat (NNT) to benefit was determined for each analysis. Statistically significant remission rate differences, favoring venlafaxine, were seen in LOCF and OC analyses for each subgroup. In patients with baseline HAM-D(17) < 25 (n = 3,928) the differences were (LOCF) 7.3 [P < 0.001; NNT = 14] and (OC) 6.2 [P = 0.003; NNT = 16], and in patients with baseline HAM-D(17) >or= 25 (n = 2,564) were (LOCF) 5.7 [P = 0.002; NNT = 17] and (OC) 6.7 [P = 0.009; NNT = 15]. In patients with baseline HAM-D(17) < 30 (n = 5,836) the differences were (LOCF) 6.4 [P < 0.001; NNT = 16] and (OC) 5.5 [P = 0.001; NNT = 18], and in patients with baseline HAM-D(17) >or= 30 (n = 656) were (LOCF) 8.9 [P = 0.015; NNT = 11] and (OC) 14.8 [P = 0.003; NNT = 7]. In conclusion, these analyses demonstrate that venlafaxine may be superior to SSRIs in achieving remission in both mild/moderate and severely depressed patients. The greater difference in remission rates among patients with baseline HAM-D(17) >or= 30 suggests a more pronounced clinical benefit that may be achieved with venlafaxine in severely depressed patients.


Asunto(s)
Antidepresivos de Segunda Generación/uso terapéutico , Ciclohexanoles/uso terapéutico , Trastorno Depresivo Mayor/tratamiento farmacológico , Trastorno Depresivo Mayor/fisiopatología , Inhibidores Selectivos de la Recaptación de Serotonina/uso terapéutico , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Evaluación de Resultado en la Atención de Salud , Escalas de Valoración Psiquiátrica , Valores de Referencia , Índice de Severidad de la Enfermedad , Estadísticas no Paramétricas , Factores de Tiempo , Clorhidrato de Venlafaxina
8.
Int Clin Psychopharmacol ; 23(6): 357-63, 2008 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-18854724

RESUMEN

The objective of this study was to evaluate the long-term efficacy of venlafaxine extended release (ER) < or =225 mg/day in patients with recurrent major depressive disorder (MDD). In this double-blind trial, outpatients with recurrent MDD (N=1096) were randomized to 10 weeks of acute-phase treatment with venlafaxine ER (75-300 mg/day) or fluoxetine (20-60 mg/day) followed by a 6-month continuation phase and two consecutive 12-month maintenance phases. At the start of each maintenance period, venlafaxine ER responders were randomized to double-blind venlafaxine ER or placebo. In this analysis, data from responders to acute and continuation treatment were analyzed during the combined maintenance phases while receiving venlafaxine ER < or =225 mg/day. Failure to maintain response was defined as an increase in maintenance dose to 300 mg/day or recurrence. Differences were calculated using Kaplan-Meier methods and compared using log-rank tests. Continuation-phase responders (n=114) receiving venlafaxine ER < or =225 mg/day comprised the analysis population (venlafaxine ER: n=55; placebo: n=59). The estimated probability for remaining well across 24 months of maintenance treatment was 67% for venlafaxine ER and 41% for placebo (P=0.007). Venlafaxine ER effectively maintained response at doses < or =225 mg/day for up to 2.5 years in patients with recurrent MDD. The findings are consistent with those of the full data set.


Asunto(s)
Antidepresivos de Segunda Generación/administración & dosificación , Ciclohexanoles/administración & dosificación , Trastorno Depresivo Mayor/tratamiento farmacológico , Fluoxetina/administración & dosificación , Adulto , Preparaciones de Acción Retardada , Trastorno Depresivo Mayor/psicología , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Femenino , Humanos , Masculino , Recurrencia , Medición de Riesgo , Factores de Tiempo , Insuficiencia del Tratamiento , Clorhidrato de Venlafaxina
9.
JMIR Res Protoc ; 6(5): e98, 2017 May 24.
Artículo en Inglés | MEDLINE | ID: mdl-28539304

RESUMEN

BACKGROUND: Quantifying anxiety and depressive experiences permits individuals to calibrate where they are and monitor intervention-associated changes. eMindLog is a novel self-report measure for anxiety and depression that is grounded in psychology with an organizing structure based on neuroscience. OBJECTIVE: Our aim was to explore the psychometric properties of eMindLog in a nonclinical sample of subjects. METHODS: In a cross-sectional study of eMindLog, a convenience sample of 198 adults provided informed consent and completed eMindLog and the Hospital Anxiety and Depression Scale (HADS) as a reference. Brain systems (eg, negative and positive valence systems, cognitive systems) and their functional states that drive behavior are measured daily as emotions, thoughts, and behaviors. Associated symptoms, quality of life, and functioning are assessed weekly. eMindLog offers ease of use and expediency, using mobile technology across multiple platforms, with dashboard reporting of scores. It enhances precision by providing distinct, nonoverlapping description of terms, and accuracy through guidance for scoring severity. RESULTS: eMindLog daily total score had a Cronbach alpha of .94. Pearson correlation coefficient for eMindLog indexes for anxiety and sadness/anhedonia were r=.66 (P<.001) and r=.62 (P<.001) contrasted with the HADS anxiety and depression subscales respectively. Of 195 subjects, 23 (11.8%) had cross-sectional symptoms above the threshold for Generalized Anxiety Disorder and 29 (29/195, 14.9%) for Major Depressive Disorder. Factor analysis supported the theoretically derived index derivatives for anxiety, anger, sadness, and anhedonia. CONCLUSIONS: eMindLog is a novel self-measurement tool to measure anxiety and depression, demonstrating excellent reliability and strong validity in a nonclinical population. Further studies in clinical populations are necessary for fuller validation of its psychometric properties. Self-measurement of anxiety and depressive symptoms with precision and accuracy has several potential benefits, including case detection, tracking change over time, efficacy assessment of interventions, and exploration of potential biomarkers.

11.
Neuropsychopharmacology ; 31(9): 1841-53, 2006 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-16794566

RESUMEN

This report summarizes recommendations from the ACNP Task Force on the conceptualization of remission and its implications for defining recovery, relapse, recurrence, and response for clinical investigators and practicing clinicians. Given the strong implications of remission for better function and a better prognosis, remission is a valid, clinically relevant end point for both practitioners and investigators. Not all depressed patients, however, will reach remission. Response is a less desirable primary outcome in trials because it depends highly on the initial (often single) baseline measure of symptom severity. It is recommended that remission be ascribed after 3 consecutive weeks during which minimal symptom status (absence of both sadness and reduced interest/pleasure along with the presence of fewer than three of the remaining seven DSM-IV-TR diagnostic criterion symptoms) is maintained. Once achieved, remission can only be lost if followed by a relapse. Recovery is ascribed after at least 4 months following the onset of remission, during which a relapse has not occurred. Recovery, once achieved, can only be lost if followed by a recurrence. Day-to-day functioning and quality of life are important secondary end points, but they were not included in the proposed definitions of response, remission, recovery, relapse, or recurrence. These recommendations suggest that symptom ratings that measure all nine criterion symptom domains to define a major depressive episode are preferred as they provide a more certain ascertainment of remission. These recommendations were based largely on logic, the need for internal consistency, and clinical experience owing to the lack of empirical evidence to test these concepts. Research to evaluate these recommendations empirically is needed.


Asunto(s)
Trastorno Depresivo Mayor/tratamiento farmacológico , Trastorno Depresivo Mayor/psicología , Ensayos Clínicos como Asunto , Trastorno Depresivo Mayor/diagnóstico , Trastorno Depresivo Mayor/terapia , Humanos , Recurrencia , Proyectos de Investigación
12.
J Clin Psychiatry ; 67(1): 15-22, 2006 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-16426083

RESUMEN

OBJECTIVE: To evaluate the efficacy and safety of high-dose sertraline for patients with obsessive-compulsive disorder (OCD) who failed to respond to standard sertraline acute treatment. METHOD: Sixty-six nonresponders to 16 weeks of sertraline treatment who met DSM-III-R criteria for current OCD were randomly assigned, in a double-blind continuation phase of a multicenter trial, either to continue on 200 mg/day of sertraline or to increase their dose to between 250 and 400 mg/day for 12 additional weeks. Efficacy measures included the Yale-Brown Obsessive Compulsive Scale (YBOCS), the National Institute of Mental Health Global Obsessive Compulsive Scale (NIMH Global OC Scale), and the Clinical Global Impressions-Severity of Illness and -Improvement (CGI-I) scales. Data were collected from July 26, 1994, to October 26, 1995. RESULTS: The high-dose (250-400 mg/day, mean final dose = 357, SD = 60, N = 30) group showed significantly greater symptom improvement than the 200-mg/day group (N = 36) as measured by the YBOCS (p = .033), NIMH Global OC Scale (p = .003), and CGI-I (p = .011). Responder rates (decrease in YBOCS score of > or = 25% and a CGI-I rating < or = 3) were not significantly different for the 200-mg/day versus the high-dose sertraline group, either on completer analysis, 34% versus 52%, or on endpoint analysis, 33% versus 40%. Both treatments showed similar adverse event rates. CONCLUSION: Greater symptom improvement was seen in the high-dose sertraline group compared to the 200-mg/day dose group during continuation treatment. Both dosages yielded similar safety profiles. Administration of higher than labeled doses of selective serotonin reuptake inhibitors may be a treatment option for certain OCD patients who fail to respond to standard acute treatment.


Asunto(s)
Trastorno Obsesivo Compulsivo/tratamiento farmacológico , Inhibidores Selectivos de la Recaptación de Serotonina/uso terapéutico , Sertralina/uso terapéutico , Adulto , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Esquema de Medicación , Resistencia a Medicamentos , Femenino , Humanos , Masculino , Trastorno Obsesivo Compulsivo/psicología , Placebos , Escalas de Valoración Psiquiátrica , Inhibidores Selectivos de la Recaptación de Serotonina/efectos adversos , Sertralina/efectos adversos , Índice de Severidad de la Enfermedad , Resultado del Tratamiento
13.
Arch Gen Psychiatry ; 62(5): 513-20, 2005 May.
Artículo en Inglés | MEDLINE | ID: mdl-15867104

RESUMEN

CONTEXT: Although various strategies are available to manage nonresponders to an initial treatment for depression, no controlled trials address the utility of switching from an antidepressant medication to psychotherapy or vice versa. OBJECTIVE: To compare the responses of chronically depressed nonresponders to 12 weeks of treatment with either nefazodone or cognitive behavioral analysis system of psychotherapy (CBASP) who were crossed over to the alternate treatment (nefazodone, n = 79; CBASP, n = 61). DESIGN: Crossover trial. SETTING: Twelve academic outpatient psychiatric centers. PATIENTS: There were 140 outpatients with chronic major depressive disorder; 92 (65.7%) were female, 126 (90.0%) were white, and the mean age was 43.1 years. Thirty participants dropped out of the study prematurely, 22 in the nefazodone group and 8 in the CBASP group. INTERVENTIONS: Treatment lasted 12 weeks. The dosage of nefazodone was 100 to 600 mg/d; CBASP was provided twice weekly during weeks 1 through 4 and weekly thereafter. MAIN OUTCOME MEASURES: The 24-item Hamilton Rating Scale for Depression, administered by raters blinded to treatment, the Clinician Global Impressions-Severity scale, and the 30-item Inventory for Depressive Symptomatology-Self-Report. RESULTS: Analysis of the intent-to-treat sample revealed that both the switch from nefazodone to CBASP and the switch from from CBASP to nefazodone resulted in clinically and statistically significant improvements in symptoms. Neither the rates of response nor the rates of remission were significantly different when the groups of completers were compared. However, the switch to CBASP following nefazodone therapy was associated with significantly less attrition due to adverse events, which may explain the higher intent-to-treat response rate among those crossed over to CBASP (57% vs 42%). CONCLUSIONS: Among chronically depressed individuals, CBASP appears to be efficacious for nonresponders to nefazodone, and nefazodone appears to be effective for CBASP nonresponders. A switch from an antidepressant medication to psychotherapy or vice versa appears to be useful for nonresponders to the initial treatment.


Asunto(s)
Antidepresivos de Segunda Generación/uso terapéutico , Terapia Cognitivo-Conductual , Trastorno Depresivo Mayor/tratamiento farmacológico , Trastorno Depresivo Mayor/terapia , Triazoles/uso terapéutico , Adulto , Enfermedad Crónica , Estudios Cruzados , Trastorno Depresivo Mayor/diagnóstico , Femenino , Humanos , Masculino , Piperazinas , Escalas de Valoración Psiquiátrica , Análisis de Regresión , Análisis de Supervivencia , Resultado del Tratamiento
14.
Artículo en Inglés | MEDLINE | ID: mdl-27835725

RESUMEN

BACKGROUND: Bright light therapy has demonstrated efficacy and is an accepted treatment for seasonal depression. It has been suggested that bright light therapy may have efficacy in nonseasonal depressions. Also, there is evidence that bright light therapy may improve responsiveness to antidepressant pharmacotherapy. DATA SOURCES: We searched PubMed/MEDLINE, PsycINFO, PsycARTICLES, CINAHL, EMBASE, Scopus, and Academic OneFile for English-language literature published between January 1998 and April 2016, using the keywords bright light therapy AND major depression, bright light therapy AND depress*, bright light therapy AND bipolar depression, bright light therapy AND affective disorders, circadian rhythm AND major depression, circadian rhythm AND depress*, and circadian rhythm AND affective disorder. STUDY SELECTION AND DATA EXTRACTION: Studies that reported randomized trials comparing antidepressant pharmacotherapy with bright light therapy ≥ 5,000 lux for ≥ 30 minutes to antidepressant pharmacotherapy without bright light therapy for the treatment of nonseasonal depression were included. Studies of seasonal depression were excluded. Following review of the initial 112 returns, 2 of the authors independently judged each trial, applying the inclusionary and exclusionary criteria. Ten studies were selected as meeting these criteria. Subjects in these studies were pooled using standard techniques of meta-analysis. RESULTS: Ten studies involving 458 patients showed improvement using bright light therapy augmentation versus antidepressant pharmacotherapy alone. The effect size was similar to that of other accepted augmentation strategies, roughly 0.5. CONCLUSIONS: Analysis of pooled data from randomized trials provides evidence for the efficacy of use of bright light therapy ≥ 5,000 lux for periods ≥ 30 minutes when used as augmentation to standard antidepressant pharmacotherapy in the treatment of major depressive disorder and bipolar depression without a seasonal pattern.


Asunto(s)
Antidepresivos/uso terapéutico , Trastorno Depresivo/terapia , Fototerapia/métodos , Terapia Combinada/métodos , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto
15.
J Clin Psychiatry ; 66 Suppl 4: 3-7, 2005.
Artículo en Inglés | MEDLINE | ID: mdl-15842181

RESUMEN

Panic disorder entered the psychiatric nomenclature a quarter-century ago, and an explosion of studies followed. Defining the core phenomenology of panic disorder can be advanced by an understanding of its pathophysiology and exploration of its etiology. The lessons learned can guide the delivery of treatments to enhance the likelihood of achieving remission and the discovery of novel treatments for panic disorder.


Asunto(s)
Trastorno de Pánico/diagnóstico , Trastorno de Pánico/etiología , Amígdala del Cerebelo/fisiología , Amígdala del Cerebelo/fisiopatología , Terapia Combinada , Manual Diagnóstico y Estadístico de los Trastornos Mentales , Humanos , Modelos Neurológicos , Vías Nerviosas/fisiopatología , Trastorno de Pánico/fisiopatología , Escalas de Valoración Psiquiátrica , Receptores Dopaminérgicos/fisiología
16.
CNS Spectr ; 10(10): suppl13 1-11; discussion 12-3; quiz 14-5, 2005 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-16404800

RESUMEN

Social anxiety disorder (SAD) is a common, chronic psychiatric disorder characterized by a persistent fear of social or performance situations in which embarrassment can occur. This disorder typically appears during the mid-adolescent years and is unremitting throughout life if not properly treated. SAD presents as two subtypes: the more common and debilitating generalized form, and the nongeneralized form, which consists predominantly of performance anxiety. The majority of patients with SAD have comorbid mental disorders, including mood, anxiety, and substance abuse. No single development theory has been proposed to account for the origins of SAD, although current understanding of the etiology of SAD posits an interaction between psychological and biological factors. Risk factors include environmental and parenting influences and dysfunctional cognitive and conditioning events in early childhood. The neurobiology of SAD appears to involve neurochemical dysfunction, as evidenced by studies of neuroreceptor imaging, neuroendocrine function, and profiles of response to specific medications. Clinical trials have demonstrated that benzodiazepines and antidepressants are effective in the treatment of SAD. The selective serotonin reuptake inhibitors are emerging as the first-line treatment for SAD, based on their proven safety, tolerability, and efficacy. Goals for ongoing future research include development of approaches to achieve remission, to convert nonresponders and partial responders to full responders, and to prevent relapse and maintain long-term efficacy. This monograph explores the epidemiology, clinical presentation, and differential diagnosis of SAD, with a focus on neural circuitry of social relationships and neurochemical dysfunction. The prevalence, rates of recognition and treatment, patterns of comorbidity, quality-of-life issues, and natural history of SAD are discussed as well as pharmacologic and psychosocial treatment strategies for SAD.


Asunto(s)
Antidepresivos/uso terapéutico , Benzodiazepinas/uso terapéutico , Medicina Basada en la Evidencia , Trastornos Fóbicos/diagnóstico , Trastornos Fóbicos/tratamiento farmacológico , Inhibidores Selectivos de la Recaptación de Serotonina/uso terapéutico , Adulto , Animales , Encéfalo/efectos de los fármacos , Encéfalo/fisiopatología , Niño , Estudios Transversales , Humanos , Lactante , Cuidados a Largo Plazo , Trastornos Fóbicos/fisiopatología , Trastornos Fóbicos/psicología , Factores de Riesgo , Socialización
17.
Artículo en Inglés | MEDLINE | ID: mdl-26137358

RESUMEN

OBJECTIVE: The purpose of this post hoc analysis was to evaluate the incidence and timing of taper/posttherapy-emergent adverse events (TPAEs) following discontinuation of long-term treatment with desvenlafaxine (administered as desvenlafaxine succinate). METHOD: This was a phase 4, randomized, double-blind, placebo-controlled study conducted at 38 research centers within the United States between March 2010 and February 2011. Adult outpatients with major depressive disorder (MDD; DSM-IV-TR criteria) who completed 24 weeks of open-label treatment with desvenlafaxine 50 mg/d were randomly assigned to 1 of 3 groups for the double-blind taper phase: desvenlafaxine 50 mg/d for 4 weeks (no discontinuation), desvenlafaxine 25 mg/d for 1 week followed by placebo for 3 weeks (taper), or placebo for 4 weeks (abrupt discontinuation). The primary endpoint, Discontinuation-Emergent Signs and Symptoms Scale (DESS) score over the first 2 weeks of the taper phase, was described previously. Secondary assessments included incidence and timing of TPAEs (any adverse event that started or increased in severity during the double-blind phase) and the percentage of patients who could not continue the taper phase due to discontinuation symptoms. The Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR16) assessed MDD status. RESULTS: A total of 480 patients enrolled in the open-label phase; the full analysis set included 357 patients (taper, n = 139; abrupt discontinuation, n = 146; no discontinuation, n = 72). TPAEs occurred in all groups through week 4. The incidence of any TPAE was lower for taper versus abrupt discontinuation at week 1 (P < .001), similar at week 2, and lower for taper versus abrupt discontinuation at weeks 3 and 4 (P ≤ .034). The most common TPAEs (incidence ≥ 3%) in the taper group were nausea and headache (3% each) at week 1 and dizziness (5%) and headache (4%) at week 2. The most common TPAEs in the abrupt discontinuation group were dizziness (8%), headache (8%), nausea (4%), irritability (3%), and diarrhea (3%) at week 1 and headache (3%) at weeks 2 and 3. The most common TPAE in the no discontinuation group was nausea (6%) at week 2. CONCLUSION: The overall incidence of any TPAE was lower in the taper versus abrupt discontinuation groups. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01056289.

18.
Biol Psychiatry ; 54(5): 573-83, 2003 Sep 01.
Artículo en Inglés | MEDLINE | ID: mdl-12946886

RESUMEN

The 16-item Quick Inventory of Depressive Symptomatology (QIDS), a new measure of depressive symptom severity derived from the 30-item Inventory of Depressive Symptomatology (IDS), is available in both self-report (QIDS-SR(16)) and clinician-rated (QIDS-C(16)) formats. This report evaluates and compares the psychometric properties of the QIDS-SR(16) in relation to the IDS-SR(30) and the 24-item Hamilton Rating Scale for Depression (HAM-D(24)) in 596 adult outpatients treated for chronic nonpsychotic, major depressive disorder. Internal consistency was high for the QIDS-SR(16) (Cronbach's alpha =.86), the IDS-SR(30) (Cronbach's alpha =.92), and the HAM-D(24) (Cronbach's alpha =.88). QIDS-SR(16) total scores were highly correlated with IDS-SR(30) (.96) and HAM-D(24) (.86) total scores. Item-total correlations revealed that several similar items were highly correlated with both QIDS-SR(16) and IDS-SR(30) total scores. Roughly 1.3 times the QIDS-SR(16) total score is predictive of the HAM-D(17) (17-item version of the HAM-D) total score. The QIDS-SR(16) was as sensitive to symptom change as the IDS-SR(30) and HAM-D(24), indicating high concurrent validity for all three scales. The QIDS-SR(16) has highly acceptable psychometric properties, which supports the usefulness of this brief rating of depressive symptom severity in both clinical and research settings.


Asunto(s)
Trastorno Depresivo Mayor/diagnóstico , Escalas de Valoración Psiquiátrica/normas , Adolescente , Adulto , Anciano , Enfermedad Crónica , Trastorno Depresivo Mayor/psicología , Trastorno Depresivo Mayor/terapia , Femenino , Humanos , Masculino , Persona de Mediana Edad , Psicometría , Autoevaluación (Psicología) , Índice de Severidad de la Enfermedad , Resultado del Tratamiento
19.
Biol Psychiatry ; 51(2): 123-33, 2002 Jan 15.
Artículo en Inglés | MEDLINE | ID: mdl-11822991

RESUMEN

BACKGROUND: Although it is known that antidepressant treatment improves psychosocial functioning, whether such changes occur independent of depressive symptoms is not known. This study compared efficacy of nefazodone, psychotherapy, and their combination in improving psychosocial functioning in chronically depressed outpatients. METHODS: Patients with chronic forms of major depressive disorder were randomized to 12 weeks of nefazodone, Cognitive Behavioral Analysis System of Psychotherapy (CBASP), or combined nefazodone/CBASP. Psychosocial assessments measured overall psychosocial functioning, work functioning, interpersonal functioning, and general health. RESULTS: Relative to community norms, patients with chronic major depression evidenced substantially impaired psychosocial functioning at baseline. Combined treatment produced significantly greater psychosocial improvement than either CBASP alone or nefazodone alone on all primary measures. Combined treatment remained superior to nefazodone on primary measures of work, social, and overall functioning, and superior to CBASP on social functioning when depressive symptoms were controlled. Unlike the two groups receiving nefazodone, CBASP alone's effect on psychosocial function was relatively independent of symptom change. Psychosocial functioning improved more slowly than depressive symptoms, and moderate psychosocial impairments remained at end point. CONCLUSIONS: Combined treatment had greater effect than either monotherapy. Change in depressive symptoms did not fully explain psychosocial improvement. Moderate residual psychosocial impairment remained, suggesting the need for continuation/maintenance treatment.


Asunto(s)
Antidepresivos de Segunda Generación/uso terapéutico , Terapia Cognitivo-Conductual , Trastorno Depresivo Mayor/terapia , Ajuste Social , Triazoles/uso terapéutico , Adulto , Antidepresivos de Segunda Generación/efectos adversos , Enfermedad Crónica , Terapia Combinada , Trastorno Depresivo Mayor/diagnóstico , Trastorno Depresivo Mayor/psicología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Piperazinas , Resultado del Tratamiento , Triazoles/efectos adversos
20.
J Clin Psychiatry ; 65(3): 414-20, 2004 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-15096082

RESUMEN

BACKGROUND: Benefit from selective serotonin reuptake inhibitor (SSRI) treatment in major depressive disorder (MDD) usually takes several weeks. Typically, a third of patients achieve remission and roughly half achieve response with acute treatment. This open-label study evaluated the efficacy and safety of modafinil treatment initiated with an SSRI in patients with MDD and fatigue. METHOD: Twenty-nine patients with DSM-IV MDD, free from antidepressant therapy (> or = 4 weeks), were administered modafinil (titrated to 200 mg/day) and fluoxetine or paroxetine (20 mg/day) for 6 weeks. Assessments included the 21-item Hamilton Rating Scale for Depression (HAM-D), Structured Interview Guide for the HAM-D (SIGH-D), Fatigue Severity Scale (FSS), and Epworth Sleepiness Scale (ESS). The SIGH-D ratings were videotaped and rated by an independent rater masked to the visit schedule. Data were collected from August 2002 through March 2003. RESULTS: Modafinil combined with an SSRI at treatment initiation significantly improved mean total SIGH-D scores within 1 week (-9.3, p <.001), and this improvement was progressive throughout the study (-21.2 at week 6, p <.001). Forty-two percent (11 of 26) and 79% (19 of 24) of patients were responders, and 39% (10 of 26) and 58% (14 of 24) of patients were remitters (HAM-D) by week 2 and week 6, respectively. Adjunct modafinil rapidly and significantly reduced fatigue (FSS score reduction from baseline = 0.7 at week 1, p <.01) and improved wakefulness (ESS score reduction from baseline = 3.6 at week 1, p <.01). The combination caused few adverse events, with nausea and headache being the most common. CONCLUSION: Modafinil combined with an SSRI at treatment initiation may enhance the onset and degree of symptom benefit in patients with MDD and fatigue. Treatment with adjunct modafinil was generally well tolerated, with most adverse effects being mild or moderate in severity.


Asunto(s)
Compuestos de Bencidrilo/uso terapéutico , Estimulantes del Sistema Nervioso Central/uso terapéutico , Trastorno Depresivo Mayor/tratamiento farmacológico , Trastorno Depresivo Mayor/psicología , Fatiga/complicaciones , Fluoxetina/uso terapéutico , Inhibidores Selectivos de la Recaptación de Serotonina/uso terapéutico , Adolescente , Adulto , Anciano , Compuestos de Bencidrilo/administración & dosificación , Manual Diagnóstico y Estadístico de los Trastornos Mentales , Trastornos de Somnolencia Excesiva/diagnóstico , Trastornos de Somnolencia Excesiva/tratamiento farmacológico , Trastornos de Somnolencia Excesiva/etiología , Quimioterapia Combinada , Fatiga/diagnóstico , Fatiga/tratamiento farmacológico , Femenino , Fluoxetina/administración & dosificación , Humanos , Masculino , Persona de Mediana Edad , Modafinilo , Proyectos Piloto , Inhibidores Selectivos de la Recaptación de Serotonina/administración & dosificación , Índice de Severidad de la Enfermedad , Encuestas y Cuestionarios
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