Observational, open-label, prospective multicenter study of sexual function in patients starting treatment with aripiprazole.

INTRODUCTION: Treatment with neuroleptics may be associated with secondary sexual dysfunction. Studies of sexual dysfunction induced by antipsychotic are important to establish the effectiveness of these agents in patients taking chronic treatments. The main objective of this study was to evaluate prospectively whether a 3 month course ofaripiprazole produces changes in the sexual function of patients with schizophrenia. METHODS: The efficacy analysis was performed in the intention-to-treat population (41 patients) and the per protocol population (36 patients). The safety analysis was based on the total sample (42 patients). RESULTS: The incidence of sexual dysfunction after 3 months of treatment with aripiprazole was zero both in patients who switched therapy due to lack of efficacy and in those taking aripiprazole as a first antipsychotic. Aripiprazole led to an improvement in the symptoms of psychosis (score on the BPRS) and lower scores on the SALSEX questionnaire.The most remarkable improvement was in delayed eyaculation/orgasm. CONCLUSION: During the 3 months of treatment, we observed an overall improvement in sexual performance, with a quicker recovery in men than in women, although recovery was similar in both at the end of treatment.

Reflexiones sobre la aplicación de la "Ley Trans” en la atención sanitaria / Reflections on the application of the “trans law” in health care

En este artículo se reflexiona sobre la reciente ley aprobada por el Congreso de los Diputados conocida como Ley 4/2023 para la igualdad real y efectiva de las personas trans y para la garantía de los derechos de las personas LGTBI (BOE-A-2023-5366, 2023). Se analizan inicialmente los artículos que más polémica han causado en el ámbito social, que son los relativos a la rectificación registral (Art. 43-51), y posteriormente los que hacen referencia directa o indirectamente a aspectos sanitarios; 1) el que prohíbe de métodos, programas o las llamadas terapias de conversión (Art. 17), 2) los que definen cómo debe ser en términos generales la atención sanitaria (Art. 56-59), y 3) finalmente el único artículo que menciona a los menores (Art 70). Se comenta que el término utilizado de persona trans, al englobar un amplio abanico de diversidades sexuales, variantes y expresiones de género, incluye tanto a personas que necesitan una atención médica como a otras que no. Se plantea que la rectificación registral acorde con esta ley 2023 al no precisar ningún requisito para su inscripción, ofrece menos garantías que la legislación ya existente de marzo 2007. Se considera que las directrices de la nueva ley se están traduciendo en una toma de decisiones por parte del usuario sin disponer de una valoración o diagnóstico por el equipo de profesionales que atienden el caso. Se destaca que la ley no incluye ninguna referencia a la atención por salud mental. Y en conjunto, se concluye que el texto aprobado, en el ámbito sanitario, puede mermar la calidad de la asistencia integral, sobre todo en menores, o personas con identidades complejas, dudosas, o con comorbilidades, que pueden generar discrepancia entre el criterio del profesional y la opinión del usuario.(AU)

Incidence of sexual dysfunction associated with antidepressant agents: a prospective multicenter study of 1022 outpatients. Spanish Working Group for the Study of Psychotropic-Related Sexual Dysfunction.

BACKGROUND: Antidepressants, especially selective serotonin reuptake inhibitors (SSRIs), venlafaxine, and clomipramine, are frequently associated with sexual dysfunction. Other antidepressants (nefazodone, mirtazapine, bupropion, amineptine, and moclobemide) with different mechanisms of action seem to have fewer sexual side effects. The incidence of sexual dysfunction is underestimated, and the use of a specific questionnaire is needed. METHOD: The authors analyzed the incidence of antidepressant-related sexual dysfunction in a multicenter, prospective, open-label study carried out by the Spanish Working Group for the Study of Psychotropic-Related Sexual Dysfunction. The group collected data from April 1995 to February 2000 on patients with previously normal sexual function who were being treated with antidepressants alone or antidepressants plus benzodiazepines. One thousand twenty-two outpatients (610 women, 412 men; mean age = 39.8 +/- 11.3 years) were interviewed using the Psychotropic-Related Sexual Dysfunction Questionnaire, which includes questions about libido, orgasm, ejaculation, erectile function, and general sexual satisfaction. RESULTS: The overall incidence of sexual dysfunction was 59.1% (604/1022) when all antidepressants were considered as a whole. There were relevant differences when the incidence of any type of sexual dysfunction was compared among different drugs: fluoxetine, 57.7% (161/279); sertraline, 62.9% (100/159); fluvoxamine, 62.3% (48/77); paroxetine, 70.7% (147/208); citalopram, 72.7% (48/66); venlafaxine, 67.3% (37/55); mirtazapine, 24.4% (12/49); nefazodone, 8% (4/50); amineptine, 6.9% (2/29); and moclobemide, 3.9% (1/26). Men had a higher frequency of sexual dysfunction (62.4%) than women (56.9%), although women had higher severity. About 40% of patients showed low tolerance of their sexual dysfunction. CONCLUSION: The incidence of sexual dysfunction with SSRIs and venlafaxine is high, ranging from 58% to 73%, as compared with serotonin-2 (5-HT2) blockers (nefazodone and mirtazapine), moclobemide, and amineptine.

Doses of olanzapine, risperidone, and haloperidol used in clinical practice: results of a prospective pharmacoepidemiologic study. EFESO Study Group. Estudio Farmacoepidemiologico en la Esquizofrenia con Olanzapina.

OBJECTIVE: The objectives of this study were to determine the doses of olanzapine (OLZ), risperidone (RIS), and haloperidol (HAL) used in clinical practice in outpatients with schizophrenia and the rates of occurrence of extrapyramidal symptoms (EPS) and other adverse events, clinical response, and use of concomitant medications. METHODS: The present study involved a subset of patients from a 6-month, open-label, prospective observational study. Data were collected by 293 psychiatrists at mental health centers and other outpatient treatment facilities in Spain. Medications and doses used, occurrence of EPS and other adverse events, and scores on the Clinical Global Impression (CGI) of Severity Scale and Global Assessment of Function (GAF) were recorded. Clinical response was defined as a decrease of > or = 2 points on the CGI, with a final CGI score < or = 4. RESULTS: A total of 2657 patients were included in the analysis. The initial and overall mean daily doses for the 3 groups were as follows: OLZ, 12.2 and 13.0 mg, respectively; RIS, 5.2 and 5.4 mg; and HAL, 13.9 and 13.6 mg. Initial and overall median daily doses were the same in each group: OLZ, 10 mg; RIS, 6 mg; and HAL, 10 mg. A significantly lower proportion of OLZ-treated patients (36.9%) experienced EPS compared with RIS-treated (49.6%) and HAL-treated (76.0%) patients (P < or = 0.001). A significantly lower proportion of patients in the OLZ group (47.8%) experienced adverse events compared with patients in the RIS (57.2%) and HAL (79.8%) groups (P < or = 0.001). A significantly greater proportion of OLZ-treated patients (37.3%) were responders compared with RIS-treated patients (31.5%) (P < 0.05). In all 3 groups, patients who had an initial CGI score > or = 5 received significantly higher overall mean daily doses than did patients with an initial CGI score < 5 (P < 0.001). A significantly lower proportion of OLZ-treated patients (10.2%) were receiving concomitant anticholinergic medication at the end of the study (month 6) compared with RIS-treated (19.9%) and HAL-treated (44.0%) patients (P < 0.001). CONCLUSION: The mean daily doses recorded in this analysis based on data from a naturalistic setting are consistent with recommendations based on clinical trials. Compared with both RIS- and HAL-treated patients, OLZ-treated patients were less likely to experience EPS or other adverse events, and less likely to use concomitant anticholinergic medications. OLZ-treated patients were also more likely to respond to treatment than were RIS-treated patients.

SSRI antidepressant use patterns and their relation to clinical global impression scores: a naturalistic study.

BACKGROUND: A cascade of events follows initial antidepressant selection which includes the subsequent antidepressant use pattern, resultant clinical outcomes, and associated health care expenditures. PURPOSE: The purpose of this study using data from a clinical practice setting was to test whether the pattern of antidepressant use was correlated with patients' treatment response as measured by the score on the Clinical Global Impression-Improvement scale. DATA AND METHODS: A retrospective dataset of patients who initiated therapy on fluoxetine, fluvoxamine, paroxetine, or sertraline in a primary care setting in Spain was used. A Cox proportional hazard analysis was used to predict the likelihood of treatment response based upon the pattern of initial antidepressant use, while minimizing the influence of other factors. RESULTS: After controlling for other observed baseline characteristics including initial disease severity, (a) patients who remained on their initial antidepressant therapy for at least 2 months with no switching, augmentation, or upward dose titration were 1.63 times more likely to experience a treatment response than patients who had an adjustment to therapy; and (b) patients who initiated therapy on sertraline were 0.46 times as likely to experience a treatment response as patients who initiated therapy on the most common study antidepressant, fluoxetine. CONCLUSION: The pattern of antidepressant use is an important determinant of treatment response among patients initiating therapy on the newer antidepressants in clinical practice.

The need for routine physical health care in schizophrenia.

When managing their patients with schizophrenia, psychiatrists are increasingly concerned about physical disorders, including weight gain, obesity, metabolic abnormalities (in particular, diabetes and the metabolic syndrome), prolactin increase, sexual dysfunction and cardiovascular disease. Other common health-related problems in these patients include recreational drug use, sedation/physical inactivity, adverse drug effects and poor self-care. Each of these can have an impact on patient well-being, adherence to therapy and life expectancy. Collectively they can pose substantial barriers to optimal outcomes. However, the widespread acknowledgement of the importance of the physical health of patients with schizophrenia does not always result in consistent monitoring and management of physical health risks in the clinic. Urgent action is needed to ensure that psychiatrists prioritise physical healthcare alongside mental healthcare as a way to improve the longterm outcomes of treatment in all patients with schizophrenia.

Management of physical health in patients with schizophrenia: practical recommendations.

Improved physical health care is a pressing need for patients with schizophrenia. It can be achieved by means of a multidisciplinary team led by the psychiatrist. Key priorities should include: selection of antipsychotic therapy with a low risk of weight gain and metabolic adverse effects; routine assessment, recording and longitudinal tracking of key physical health parameters, ideally by electronic spreadsheets; and intervention to control CVD risk following the same principles as for the general population. A few simple tools to assess and record key physical parameters, combined with lifestyle intervention and pharmacological treatment as indicated, could significantly improve physical outcomes. Effective implementation of strategies to optimise physical health parameters in patients with severe enduring mental illness requires engagement and communication between psychiatrists and primary care in most health settings.

Presence and predictors of pain in depression: results from the FINDER study.

BACKGROUND: Patients with depression often experience pain. There is limited understanding of the relation between pain and other symptoms (depressive, anxious and non-painful somatic symptoms). This exploratory study assesses pain severity and interference of pain with functioning in a clinically depressed population and investigates the relation between the different groups of symptoms. METHODS: FINDER was a 6-month prospective, observational study investigating health-related quality of life of outpatients with depression initiating antidepressant treatment. Patients completed ratings on the Hospital Anxiety and Depression Scale (HADS), Somatic Symptom Inventory (SSI-28), and overall pain severity and interference of pain with functioning using Visual Analogue Scales (VAS) at baseline and at 3 and 6 months. Regression analyses identified factors associated with overall pain severity and interference of pain with functioning, at baseline and over the observation period. RESULTS: Of 3468 eligible patients at baseline, 56.3% experienced moderate to severe pain and 53.6% had moderate to severe pain-related interference with functioning. At 6 months of follow-up, these proportions decreased to 32.5% and 28.1%, respectively. Higher baseline SSI-somatic scores (non-painful) were strongly associated with greater pain severity and greater pain-related interference with functioning at baseline and over 6 months. Certain socio-demographic (increasing age, being unemployed) and depression-related factors (more previous episodes, longer duration of current episode) were also significantly associated with greater pain severity and interference over 6 months, while higher baseline severity of depression (HADS-D) and further education were associated with less severe pain or pain-related interference with functioning over 6 months. CONCLUSIONS: Over half of depressed patients in this study experienced moderate to severe pain. Painful somatic symptoms appear to be closely related to non-painful somatic symptoms, more than to depressive or anxious symptoms suggesting that painful and non-painful somatic symptoms can be considered as one group of 'somatic symptoms,' all of them associated with depressive and anxious symptoms.

Better sexual acceptability of agomelatine (25 and 50 mg) compared with paroxetine (20 mg) in healthy male volunteers. An 8-week, placebo-controlled study using the PRSEXDQ-SALSEX scale.

Sexual dysfunction (SD) is a common and underestimated effect of antidepressants. Healthy volunteers are the most adequate group to study this adverse event avoiding influence of depression itself. Sexual acceptability of agomelatine (a melatonergic agonist and 5HT(2C) antagonist) paroxetine and placebo by using the Psychotropic-Related Sexual Dysfunction Salamanca Sex Questionnaire (PRSEXDQ-SALSEX) was explored. A total of 92 healthy male volunteers were randomised to agomelatine (25 or 50 mg), paroxetine 20 mg or placebo for 8 weeks. SD, defined as at least one sexual impairment in one of the following PRSEXDQ-SALSEX items (decreased libido, delayed orgasm/ejaculation, anorgasmia/no ejaculation and erectile dysfunction), was evaluated at baseline and after 2, 4 and 8 weeks. At the last post-baseline assessment, SD was significantly lower in each agomelatine group (22.7% on 25 mg and 4.8% on 50 mg) than in the paroxetine group (85.7%; p < 0.0001). In the placebo group, 8.7% of volunteers reported a SD. The percentages of volunteers with moderate or severe SD were 4.5% for agomelatine 25 mg, 4.8% for agomelatine 50 mg, 61.9% for paroxetine 20 mg and 0% in the placebo group (p < or = 0.0001 agomelatine versus paroxetine). There is a much lower risk of having SD with agomelatine than paroxetine in healthy male volunteers, which confirms the better sexual acceptability profile of agomelatine compared with the SSRIs.

[Analysis of prescription patterns of antipsychotic agents in psychiatry]. / Análisis de los patrones de prescripción de antipsicóticos en psiquiatría.

INTRODUCTION: We describe the different diseases in which conventional and second generation antipsychotic (APS) prescriptions are made. METHOD: Observational, retrospective, multicenter study based on the review of 300 clinical records of public and private sites, hospital and out-patient clinics, located in Salamanca, Vigo, Bilbao, Barcelona, Valencia, Oviedo and Malaga. RESULTS: The mean age of the population studied was 42 +/- 17 years; 56.6 % were men. Atypical drugs (67 %) were used basically versus classical ones (33 %). Classical APS are basically prescribed in bipolar disorder with/without psychotic symptoms (20.6 %), schizophrenia (18.3%) and delusional disorder (11.5 %). Atypical APS are fundamentally prescribed in schizophrenia (31.5 %), bipolar disorders with/without psychotic symptoms (12.5 %) and other psychotic disorders (8.9 %). When the psychotic disorders are considered by groups (schizophrenia, bipolar disorder with psychotic symptoms, delusional disorder and other psychotic disorders), classical APS are used in 47.4 % and atypical APS in 62.5%. APS were used ((outside the indication)) (off-label) in 32.8%, including resistant depressions, serious obsessive-compulsive disorder and borderline personality disorder, with similar percentages for both conventional and atypical ones. In dementia, atypical APS were used in 5.1 % versus 1.5 % of the conventional ones. The most frequent reasons for prescription of classical APS were control of psychotic symptoms (33.6 %), aggressiveness-agitation (31.3 %), severe insomnia (16 %), impulsivity (6.9 %) and severe anxiety (6.1 %). Atypical APS were preferably used in the control of psychotic symptoms (58.8%) and aggressiveness-agitation (25.5%). CONCLUSIONS: The use of APS basically occurs within their authorized indications (67.2 %). The off-label use (32.8 %) occurs both for the classical as well as atypical APS and occurs in serious diseases in which there are no alternative treatments.

[Quality of life and social functioning in schizophrenic patients treated with olanzapine: 1 year follow-up naturalistic study]. / Calidad de vida y funcionamiento social en pacientes con esquizofrenia en monoterapia con olanzapina: estudio naturalístico de 1 año de seguimiento.

OBJECTIVE: To measure health related quality of life (HRQL) and social functioning in schizophrenic patients treated with olanzapine under regular clinical practice conditions. METHODS: Out-patients diagnosed of schizophrenia and beginning treatment with olanzapine, quetiapine, risperidone or typical oral antipsychotics were included. Information on socio-demographic characteristics was obtained and in each visit (baseline, 3, 6 and 12 months) they were administered the generic HRQL questionnaire Euro-QoL-5D (EQ-5D) and the Social Functioning Scale (SFS). RESULTS: A total of 1,198 patients were followed-up for 12 months. Mean age (SD) was 38.6 (13.3) years and 62.9 % of them were men. In basal conditions the most affected dimensions of EQ-5D were anxiety/depression (76 %), and daily activities (73.6 %). After 12 months treatment the cohort of patients treated with olanzapine showed a better HRQL in the self-care dimension compared to all other treatments (p < 0.05), and in the dimensions of pain/discomfort, anxiety/depression and usual activities compared to the group treated with quetiapine and risperidone (p < 0.05). The Visual Analogue Scale (VAS) of the EQ-5D questionnaire showed a better health state after 12 months in the group treated with olanzapine compared to the groups of quetiapine or risperidone (p < 0.05). The SFS showed a better improvement in the cohort of olanzapine in the three studied dimensions after 12 months: isolation and social relationships in comparison to the risperidone group (p < 0.05), interpersonal communication in comparison to the risperidone and quetiapine group (p < 0.05) and independence performance in comparison to all the other treatments (p < 0,05). CONCLUSION: Schizophrenic patients treated with olanzapine for one year show a better improvement in HRQL and social functioning than those treated with other antipsychotics.

[The European schizophrenia outpatient health outcomes (SOHO) study: baseline findings of the Spanish sample]. / Estudio observacional paneuropeo de la efectividad de la olanzapina frente a otros antipsicóticos (SOHO): resultados basales de la muestra española.

INTRODUCTION: To describe the baseline findings and study population of the Spanish sample of the Schizophrenia Outpatient Health Outcomes (SOHO) Study. METHOD: The SOHO study is an ongoing, large, prospective, long-term observational study of schizophrenia treatment in 10 European countries. The study population consists of outpatients who initiate therapy or change to a new antipsychotic. RESULTS: A total of 86 investigators enrolled 2,020 in Spain (10,972 patients in Europe). 64 % of patients were men and the mean age was 38.7 years. The Spanish SOHO study sample had considerable functional impairment at baseline. The main reason for change of therapy was lack effectiveness followed by intolerability. Patients included in the study and those receiving their first antipsychotic for schizophrenia are most likely to receive an atypical agent. CONCLUSION: The Spanish SOHO study population appears to represent the Spanish outpatients with schizophrenia in whom a treatment decision is required. Baseline findings reflect Spanish clinical practice with respect to patients treated with individual antipsychotics.

[Pattern of usage of new antidepressants in clinical practice]. / Patrón de uso de los nuevos antidepresivos en la práctica clínica.

INTRODUCTION: Data from naturalistic studies have reported differences in the clinical use of antidepressants referring to the need for adjusting doses, treatment duration, tolerability and use of concomitant medication. These differences could be considered as an indicator of the effectiveness of antidepressants in clinical practice settings. OBJECTIVES: It is a naturalistic, retrospective, observational study which objective is to evaluate and compare the pattern of antidepressant use (fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine) and to establish if there is a relation between the different pattern of use and the effectiveness of them. DATA AND METHODS: A retrospective dataset of patients who initiated therapy on fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine with a follow-up period of 6 months was used. Information about clinical characteristics of patients and antidepressant pattern of use were collected. Pattern of antidepressant use were defined as: "initial doses", "upward dose titration", "augmentation strategy", "switching" and "early interruption of treatment". The efficacy of the therapy was assessed by the CGI-improvement. RESULTS: Fluoxetine was the antidepressant more associated with a statistical significance (p = 0.001) to an stable pattern of use (initial doses without upward dose titration, switching or augmentation). After controlling for other observed baseline characteristics, patients who remained on their initial antidepressant therapy, with a stable pattern of use were 1.61 times more likely than patients who had an adjustment to therapy to experience a treatment response. Patients who initiated treatment with sertraline or venlafaxine were 2.155 and 4.831 times less likely, respectively, to experience a response relative to patients who initiated therapy on fluoxetine. CONCLUSIONS: The need to upward dose titration, switching or augmentation in the treatment could be indicated a worse therapeutic control of the symptoms. Patients treated with fluoxetine are in a stable pattern of use more likely than patients in the other antidepressants, this fact is related with better global therapeutic results.

[Psychooncology: anxiety]. / Psicooncología: ansiedad.

Some specific aspects of Psychooncology, particularly different types of anxiety, are revised and classified according to its causes (situational, somatic, postreactivation and posttherepeutic) and to the time of onset (postdiagnosis, postreatment and terminal states). Therapeutical guides are proposed.

[Psychometric characteristics of the psychotropic-related sexual dysfunction questionnaire. Spanish work group for the study of psychotropic-related sexual dysfunctions]. / Propiedades psicométricas del Cuestionario de Disfunción Sexual Secundaria a Psicofármacos. Grupo Español de Trabajo Para El Estudio de las Disfunciones Sexuales Secundarias a Psicofármacos.

BACKGROUND: The presence of sexual function impairment in patients with psychiatric disorders is very common and could be an effect of the medication (mainly antidepressant and neuroleptics). The patient frequently has difficulties to communicate this adverse effect and the assessment of these changes by the physician should be encouraged. The real SD incidence is underestimated and the use of a specific questionnaire is needed. METHODS: The authors analyse psychometric characteristics of the Psychotropic-Related Sexual Dysfunction Questionnaire (PRSexDQ) that includes questions about libido, orgasm, ejaculation, erectile function and general sexual satisfaction. The questionnaire was applied to 62 patients who were taking nefazodone "de novo" (n = 18) or were switched to nefazodone (n = 44) due to bad tolerated sexual dysfunction secondary to other antidepressant. RESULTS: The PRSexDQ has shown an excellent feasibility with nil percentage of patients with missing responses on all items except on items 1 and 2 (1.7% and 15.5% of patients with missing response). Cronbach's alpha value was 0.93, which indicates adequate reliability. The PRSexDQ also showed adequate construct validity. As it may be expected, the PRSexDQ showed a high correlation with a Clinical Global Impression scores on Sexual Dysfunction (r = 0.79) and moderate correlation with Hamilton Depression scores (r = 0.63). PRSexDQ also showed good discrimination between naive and pretreated depressed or dysthymic patients, with statistically significant differences between those groups of patients. Finally, the instrument showed adequate sensitivity for detecting clinical changes on sexual dysfunction with greater changes in the patients treated previously with antidepressants and who were switched to nefazodone than in naive patients (SES = -3.77 in patients switching to nefazodone; SES = -0.64 in naive patients).

[Psycho-oncology: influence of external perception on the personality characteristics in women with cancer]. / Psicooncología: influencia de la percepción externa sobre los rasgos de personalidad en mujeres con cáncer.

Personality traits between two female groups suffering cancer with different symptomatology and treatment are compared. The authors study 59 female patients: 35 with breast cancer and 24 with hematologic neoplasia. The MMPI Inventory and the Scale to Measure of Aggression by Ledesma et al were studied. It has been found that there are similar personality traits in both groups although there are some significant differences. The group with breast cancer showed an increase both in the MMPI Si scale (Social introversion) and in self aggression with respect to the hematologic neoplasia group. On the other hand, the patients with hematologic cancer showed an increase of the hypochondria, depression and paranoia as well as hetero aggression.

[The costs of treatment with the new antidepressants in clinical practice]. / Costes del tratamiento con nuevos antidepresivos en la práctica clínica.

OBJECTIVE: To assess if, in usual clinical practice, the patterns of use of new antidepressant are associated to different health resource utilisation. DESIGN: Naturalistic, retrospective, observational study. SETTING: Urban health center. PATIENTS: DSM-IIIR diagnostic criteria of depressive disorder and treatment with a new antidepressant (n = 328). INTERVENTIONS: Information on resource utilisation was collected in those patients treated with fluoxetine (FLX), fluvoxamine (FLV) sertraline (SER), paroxetine (PAR) and venlafaxine (VLF). Direct, indirect and total costs were compared according to the different patterns of use (stable therapy, upward dose titration, switching or augmentation) and according to the initially prescribed antidepressant. The follow-up period was 6 months. RESULTS: Direct and total daily costs of those patients with unestable therapy (upward dose titration, switching or augmentation) were 55% (p < 0.01) and 87% (p = 0.001) higher than for patients with stable therapy, respectively. Patients who initiated therapy on SER, VLF and PAR had 35% (p < 0.05), 80% (p < 0.05) and 37% (p < 0.05), respectively, higher average total costs per day than patients who initiated therapy with FLX. Regarding direct costs, patients who initiated therapy on SER and VLF had 48% (p < 0.001) and 58% (p < 0.05) higher average costs per day than patients who initiated therapy with FLX. CONCLUSIONS: New antidepressants show different patterns of use in a clinical practice setting, being FLX the agent more associated to a stable pattern of use. The pattern of use is associated to different health resource utilisation. Patients under stable therapy show lower health costs than those who need upward titration, switching or augmentation strategies. It is necessary to conduct randomized naturalistic studies to confirm these results.

Fluoxetine in the prevention of depressive recurrences: a double-blind study.

Optimal outcomes from depression treatment are long-term recovery and, in the case of recurrent depression, prevention of new episodes. However, few data are available concerning the long-term efficacy of antidepressants in prophylactic treatment to prevent recurrences of depression. The efficacy and safety of fluoxetine 20 mg/day was evaluated in reducing the number of depressive episodes and in extending the time free of symptoms in patients with recurrent unipolar major depression. Patients with recurrent unipolar major depression according to DSM-III-R criteria and who responded to 32 weeks of open-label fluoxetine were randomly assigned to receive fluoxetine 20 mg/day (N = 70) or placebo (N = 70) for 48 weeks of double-blind maintenance treatment. Outcome measures were the percentage of recurrences and time to recurrence. Safety assessments included treatment-emergent adverse events, reasons for discontinuation, vital signs, and laboratory measures. Fluoxetine was associated with a statistically significantly smaller percentage of patients who had a recurrence compared with placebo (20% vs. 40%; chi2 analysis, p = 0.010). The symptom-free period was significantly longer for patients treated with fluoxetine versus placebo (295 vs. 192 days; Kaplan-Meier estimates, log-rank test, p = 0.002). Treatments were well tolerated during maintenance treatment. The only statistically significant difference in adverse events between treatment groups was anxiety, which was more frequent in the placebo group (fluoxetine, 12.9% vs. placebo, 30%; chi2 analysis, p = 0.013). Two placebo-treated patients and no fluoxetine-treated patients were withdrawn because of adverse events. In conclusion, fluoxetine at 20 mg/day was effective and well tolerated for the prophylactic treatment of recurrent unipolar major depression.

[Sexual dysfunction with antidepressive agents. Effect of the change to amineptine in patients with sexual dysfunction secondary to SSRI]. / Disfunción sexual con antidepresivos. Efecto del cambio a amineptino en pacientes con disfunción sexual secundaria a ISRS.

UNLABELLED: Sexual dysfunction secondary to the use of antidepressants, especially clomipramine or SSRI's is an adverse effect that is often underestimated and according to earlier studies, this can affect approximately 60% of the patients. This presents as a decrease in libido, alterations in the ability to reach orgasm/ejaculation, and an erectile dysfunction or a decreased vaginal lubrication. This dysfunction appears to be related with the resulting increase in serotonin and with the stimulation of serotonin 5HT2 receptors. OBJECTIVES: 1) Evaluate the effect of amineptine, a drug with an increased dopamine transmission and scant serotonin transmission, on the sexual function of depressed patients who begin treatment, and 2) evaluate whether the change to amineptine improves the sexual function in patients who presented sexual dysfunction after beginning treatment with a SSRI. MATERIAL AND METHODS: Prospective, observational, open and multicentric design. 111 patients with an average age of 41.3 years (36 men, 75 women) were distributed into three groups: Group 1 (n= 26): patients with depression (DSM IV) who begin de novo treatment with amineptine 200 mg/day. Group 2 (n= 47): depressed patients undergoing treatment with a SSRI who show a favorable response and who present sexual dysfunction secondary to a poorly tolerated treatment, so the treatment is changed to 200 mg/day of amineptine. Group 3 (n= 38): patients with the same characteristics as those of group 2, but whose treatment was changed to 20 mg/day of paroxetine. The <> (Montejo et al, 1996) was used together with the Hamilton Depression Scale, the IGC Scale, and an adverse events scale, over a 6 months follow up period during which visits took place at: baseline, month 1, month 2, month 3, and month 6. RESULTS: In group 1, treated with amineptine from the beginning, of the 5 patients who showed a decrease in the libido at the beginning of the treatment, only one still presented this in the 6th month. The Hamilton Scale decreased from 23.12 (baseline) to 5.25 after 6 months. After substituting amineptine for SSRI's in patients with sexual dysfunction, the incidence of any type of sexual dysfunction decreased significantly from 100% (baseline) to 55.3% after 6 months. (P< 0.001). The incidence of delayed orgasm dropped to 15.8%, anorgasmia to 17.4%, and impotence dropped to 15.8% in this group, with the antidepressant effect that had already been achieved with the SSRI being maintained. However, in group 3 there was barely any improvement on the sexual function after changing to paroxetine (20 mg/day), with the baseline incidence being 100% and the incidence after 6 months being 89.7%. In this last group the antidepressant effect present at the baseline level, was maintained. CONCLUSIONS: Amineptine was shown to be an effective antidepressant in the patients studied, and did not cause secondary sexual dysfunction, and even improved the dysfunction that was present in some patients. In those patients previously treated with SSRI's, amineptine is able to significantly improve the sexual dysfunction and yet maintain the efficacy of the antidepressive treatment used before these 6 months. On the other hand, Paroxetine did not improve the sexual dysfunction of the people in whom this drug substituted another SSRI, as this is an adverse effect common to the entire group of selective serotonin re-uptake inhibiting drugs. Amineptine showed a good safety and tolerance profile. Its most common side effect (anxiety/restlessness) disappeared 2 months after the beginning of the treatment.

Estudio sobre la función sexual de pacientes que inician tratamiento con aripiprazol. Estudio naturalístico, abierto, prospectivo y multicéntrico / Observational, Open-Label, Prospective Multicenter Study of Sexual Function in Patients Starting Treatment with Aripiprazole

Introducción. El tratamiento con neurolépticos puede asociarse a disfunción sexual secundaria. Los estudios sobre la disfunción sexual secundaria a antipsicóticos son importantes para poder establecer la eficiencia de estos fármacos en los tratamientos crónicos. El objetivo principal de este estudio ha sido valorar de forma prospectiva si el aripiprazol produce modificaciones en la función sexual de los pacientes con esquizofrenia 3 meses después de su instauración. Métodos. El análisis de eficacia se efectuó en dos poblaciones, la población para intención de tratamiento (41pacientes) y la población por protocolo (36 pacientes). El análisis de seguridad se ha realizado en la muestra total (42 pacientes). Resultados. Incidencia nula de disfunción sexual a los 3 meses de tratamiento con aripiprazol, tanto en los pacientes que recibían aripiprazol como primer antipsicótico como en los que habían cambiado a aripiprazol debido a una falta de eficacia de otro antipsicótico. Además de producir una mejoría de los síntomas de psicosis (escala BPRS), el aripiprazol disminuyó la puntuación en la escala SALSEX, siendo el retraso en la eyaculación u orgasmo el que presentó una mejoría media más marcada. Conclusiones. Mejoría global del funcionamiento sexual durante los 3 meses de tratamiento con aripiprazol, que muestra una recuperación más rápida en los hombres que en las mujeres, aunque ambos consiguen una recuperación similar (AU)

Introduction. Treatment with neuroleptics maybe associated with secondary sexual dysfunction. Studies of sexual dysfunction induced by antipsychotic are important to establish the effectiveness of these agents in patients taking chronic treatments. The main objective of this study was to evaluate prospectively whether a 3 month course of aripiprazole produces changes in the sexual function of patients with schizophrenia. Methods. The efficacy analysis was performed in the intention-to-treat population (41 patients) and the perprotocol population (36 patients). The safety analysis was based on the total sample (42 patients). Results. The incidence of sexual dysfunction after 3months of treatment with aripiprazole was zero both in patients who switched therapy due to lack of efficacy and in those taking aripiprazole as a first antipsychotic. Aripiprazole led to an improvement in the symptoms of psychosis (score on the BPRS) and lower scores on the-SALSEX questionnaire. The most remarkable improvement was in delayed eyaculation /orgasm. Conclusion. During the 3 months of treatment, we observed an overall improvement in sexual performance, with a quicker recovery in men than in women, although recovery was similar in both at the end of treatment (AU)