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1.
J Clin Psychiatry ; 81(6)2020 Oct 20.
Artigo em Inglês | MEDLINE | ID: mdl-33084254

RESUMO

OBJECTIVE: The aim of this study was to determine the efficacy of mirtazapine, a tetracyclic antidepressant, as monotherapy for the treatment of posttraumatic stress disorder (PTSD). METHODS: This multisite, randomized, double-blind, placebo-controlled trial was conducted between April 2006 and November 2010 at the Tuscaloosa and Birmingham Veterans Affairs Medical Centers in Alabama. US military veterans who met DSM-IV criteria for PTSD were randomly assigned to placebo (n = 39) or mirtazapine (n = 39) titrated up to 45 mg/d for an 8-week double-blind period followed by an 8-week open-label phase of mirtazapine treatment. The primary outcome efficacy measure was the Structured Interview for Posttraumatic Stress Disorder (SIP). Secondary measures included other measures of PTSD, depression, and sleep. Analyses of treatment groups involved mixed-model procedures using a random intercept to test the hypotheses that mirtazapine would be more effective than placebo in reducing symptoms of PTSD and depression and improving quality of sleep. RESULTS: Seventy-eight participants were randomized with 61 completing the 8-week controlled phase and 48 completing the open-label phase. No significant differences were observed between groups on the primary outcome of SIP scores during the controlled phase (P = .418). In secondary outcomes, significant improvements per the Clinical Global Impressions-Improvement scale were found for the mirtazapine group compared to the placebo group (P = .041). The 8-week open-label phase demonstrated significant symptom improvement in SIP total score (P = .0003) and in scores on the SIP re-experiencing (P = .0007), avoidance (P = .0309), and hyperarousal (P = .0014) subscales. There were no significant differences in the occurrence of adverse events between groups. CONCLUSIONS: This study did not show efficacy of mirtazapine monotherapy in the treatment of PTSD. Identification of more effective treatments, either as monotherapy or adjunctive, for PTSD is imperative. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00302107.

2.
J Clin Psychiatry ; 81(4)2020 06 23.
Artigo em Inglês | MEDLINE | ID: mdl-32603560

RESUMO

OBJECTIVE: To determine whether concurrent posttraumatic stress disorder (PTSD) should affect whether to augment or switch medications when major depressive disorder (MDD) has not responded to a prior antidepressant trial. METHODS: Patients at 35 Veterans Health Administration medical centers from December 2012 to May 2015 with nonpsychotic MDD (N = 1,522) and a suboptimal response to adequate antidepressant treatment were randomly assigned to 3 "next step" treatments: switching to bupropion, augmenting the current antidepressant with bupropion, and augmenting with the antipsychotic aripiprazole. Blinded ratings with the 16-item Quick Inventory of Depressive Symptomatology-Clinician Rated (QIDS-C16) determined remission and response by 12 weeks and relapse after remission. Survival analyses compared treatment effects in patients with concurrent PTSD diagnosed with the Mini-International Neuropsychiatric Interview (n = 717, 47.1%) and those without PTSD (n = 805, 52.9%). RESULTS: Patients diagnosed with PTSD showed more severe depressive symptoms at baseline and were less likely to achieve either remission or response by 12 weeks. Augmentation with aripiprazole was associated with greater likelihood of achieving response (68.4%) than switching to bupropion (57.7%) in patients with PTSD (relative risk [RR] = 1.26; 95% CI, 1.01-1.59) as well as in patients without PTSD (RR = 1.29; 95% CI, 1.05-1.97) (78.9% response with aripiprazole augmentation vs 66.9% with switching to bupropion). Treatment comparisons with the group receiving augmentation with bupropion were not significant. There was no significant interaction between treatment group and PTSD on remission (P = .70), response (P = .98), or relapse (P = .15). CONCLUSIONS: Although PTSD was associated with poorer overall outcomes, the presence of concurrent PTSD among Veterans in this trial did not affect the comparative effectiveness of medications on response, remission, or relapse after initial remission. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01421342.


Assuntos
Transtorno Depressivo Maior/tratamento farmacológico , Transtorno Depressivo Resistente a Tratamento/tratamento farmacológico , Transtornos de Estresse Pós-Traumáticos/tratamento farmacológico , Adolescente , Adulto , Antidepressivos/uso terapêutico , Aripiprazol/uso terapêutico , Bupropiona/uso terapêutico , Transtorno Depressivo Maior/complicações , Resistência a Medicamentos/efeitos dos fármacos , Quimioterapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Método Simples-Cego , Transtornos de Estresse Pós-Traumáticos/complicações , Adulto Jovem
3.
BMC Med Res Methodol ; 20(1): 33, 2020 02 17.
Artigo em Inglês | MEDLINE | ID: mdl-32066380

RESUMO

BACKGROUND: This article describes the design and baseline sample of a single-site trial comparing Individual Placement and Support (IPS) supported employment delivered within a Veterans Health Administration (VHA) primary care Patient Aligned Care Team (PACT) to treatment-as-usual vocational rehabilitation (TAU-VR) that includes transitional work. METHODS: Unemployed U.S. military veterans receiving care in a VHA PACT who were seeking competitive work, otherwise eligible for vocational rehabilitation, and diagnosed with a mental health condition other than a psychotic or bipolar I disorder were prospectively randomized to receive either IPS or TAU-VR. Employment outcomes and measures of quality of life, self-esteem, and community reintegration are being collected for 12 months. RESULTS: The participant sample (n = 119) is comprised of 17.6% female, 73.1% African-Americans, and 1.7% Hispanic. Average age is 38.2 (SD ± 8.41) years; 80.7% served in the military since 2001; 78% are receiving or applying for U.S. Department of Veterans Affairs (VA) service-connected disability; 26.9% have not held a competitive job in the past 3 years; and the average length of pre-randomization unemployment is 1.4 (SD ± 2.3) years. CONCLUSIONS: Unique design features include evaluating the efficacy of evidenced-based IPS within the primary care setting, having broad diagnostic eligibility, and defining the primary outcome criterion as "steady employment", i.e. holding a competitive job for ≥26 weeks of the 12-month follow-up period. The findings illustrate the characteristics of a primary care veteran sample in need of employment services. TRIAL REGISTRATION: www.clinicaltrials.gov Identifier: NCT02400736.

4.
JAMA ; 318(2): 132-145, 2017 Jul 11.
Artigo em Inglês | MEDLINE | ID: mdl-28697253

RESUMO

Importance: Less than one-third of patients with major depressive disorder (MDD) achieve remission with their first antidepressant. Objective: To determine the relative effectiveness and safety of 3 common alternate treatments for MDD. Design, Setting, and Participants: From December 2012 to May 2015, 1522 patients at 35 US Veterans Health Administration medical centers who were diagnosed with nonpsychotic MDD, unresponsive to at least 1 antidepressant course meeting minimal standards for treatment dose and duration, participated in the study. Patients were randomly assigned (1:1:1) to 1 of 3 treatments and evaluated for up to 36 weeks. Interventions: Switch to a different antidepressant, bupropion (switch group, n = 511); augment current treatment with bupropion (augment-bupropion group, n = 506); or augment with an atypical antipsychotic, aripiprazole (augment-aripiprazole group, n = 505) for 12 weeks (acute treatment phase) and up to 36 weeks for longer-term follow-up (continuation phase). Main Outcomes and Measures: The primary outcome was remission during the acute treatment phase (16-item Quick Inventory of Depressive Symptomatology-Clinician Rated [QIDS-C16] score ≤5 at 2 consecutive visits). Secondary outcomes included response (≥50% reduction in QIDS-C16 score or improvement on the Clinical Global Impression Improvement scale), relapse, and adverse effects. Results: Among 1522 randomized patients (mean age, 54.4 years; men, 1296 [85.2%]), 1137 (74.7%) completed the acute treatment phase. Remission rates at 12 weeks were 22.3% (n = 114) for the switch group, 26.9% (n = 136)for the augment-bupropion group, and 28.9% (n = 146) for the augment-aripiprazole group. The augment-aripiprazole group exceeded the switch group in remission (relative risk [RR], 1.30 [95% CI, 1.05-1.60]; P = .02), but other remission comparisons were not significant. Response was greater for the augment-aripiprazole group (74.3%) than for either the switch group (62.4%; RR, 1.19 [95% CI, 1.09-1.29]) or the augment-bupropion group (65.6%; RR, 1.13 [95% CI, 1.04-1.23]). No significant treatment differences were observed for relapse. Anxiety was more frequent in the 2 bupropion groups (24.3% in the switch group [n = 124] vs 16.6% in the augment-aripiprazole group [n = 84]; and 22.5% in augment-bupropion group [n = 114]). Adverse effects more frequent in the augment-aripiprazole group included somnolence, akathisia, and weight gain. Conclusions and Relevance: Among a predominantly male population with major depressive disorder unresponsive to antidepressant treatment, augmentation with aripiprazole resulted in a statistically significant but only modestly increased likelihood of remission during 12 weeks of treatment compared with switching to bupropion monotherapy. Given the small effect size and adverse effects associated with aripiprazole, further analysis including cost-effectiveness is needed to understand the net utility of this approach. Trial Registration: clinicaltrials.gov Identifier: NCT01421342.


Assuntos
Antidepressivos/administração & dosagem , Antipsicóticos/uso terapêutico , Aripiprazol/uso terapêutico , Bupropiona/administração & dosagem , Transtorno Depressivo Maior/tratamento farmacológico , Substituição de Medicamentos , Adulto , Antidepressivos/uso terapêutico , Resistência a Medicamentos , Sinergismo Farmacológico , Quimioterapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Indução de Remissão , Estados Unidos , Veteranos
5.
Psychopharmacol Bull ; 46(2): 8-17, 2016 Aug 15.
Artigo em Inglês | MEDLINE | ID: mdl-27738377

RESUMO

OBJECTIVE: Selective serotonin reuptake inhibitors (SSRIs) remain the first-line treatment for posttraumatic stress disorder (PTSD). However, adjunctive atypical antipsychotics are often used to target residual or refractory symptoms. Asenapine is a novel atypical antipsychotic that possesses a high serotonin (5-HT2A) to dopamine (D2) affinity ratio and alpha-adrenergic antagonism, which may be advantageous in treating PTSD. This pilot study aimed to identify the therapeutic potential of asenapine as an adjunctive treatment for PTSD. METHOD: Eighteen subjects initiated treatment in this single-site prospective, open-label, 12-week trial of flexibly-dosed asenapine in Veterans with PTSD who had not responded to an adequate course of treatment with an SSRI, venlafaxine, or mirtazapine. Subjects remained on their antidepressant medication and were started on adjunctive asenapine 5 mg sublingual at bedtime, which was gradually titrated to a maximum of 10 mg twice per day, as tolerated. The primary outcome measure was the Clinician Administered PTSD Scale (CAPS) for DSM-IV. RESULTS: Fifteen subjects finished at least 4 weeks and eleven completed the 12 week study. There was a significant and clinically meaningful decrease in CAPS from baseline (77.56 ± 14.48) to week 4 (48.7 ± 30.6), and to week 12 (35.3 ± 19.7). Six participants experienced adverse events possibly related to asenapine; however, only three participants discontinued early due to related adverse events. CONCLUSION: This pilot study demonstrated that adjunctive treatment with asenapine may provide additional benefit to some patients experiencing residual PTSD symptoms in spite of optimal antidepressant therapy. A larger efficacy study may be warranted.


Assuntos
Antipsicóticos/uso terapêutico , Compostos Heterocíclicos de 4 ou mais Anéis/uso terapêutico , Transtornos de Estresse Pós-Traumáticos/tratamento farmacológico , Humanos , Projetos Piloto , Estudos Prospectivos , Escalas de Graduação Psiquiátrica , Resultado do Tratamento
6.
J Affect Disord ; 206: 232-240, 2016 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-27479536

RESUMO

OBJECTIVE: Finding effective and lasting treatments for patients with Major Depressive Disorder (MDD) that fail to respond optimally to initial standard treatment is a critical public health imperative. Understanding the nature and characteristics of patients prior to initiating "next-step" treatment is an important component of identifying which specific treatments are best suited for individual patients. We describe clinical features and demographic characteristics of a sample of Veterans who enrolled in a "next-step" clinical trial after failing to achieve an optimal outcome from at least one well-delivered antidepressant trial. METHODS: 1522 Veteran outpatients with nonpsychotic MDD completed assessments prior to being randomized to study treatment. Data is summarized and presented in terms of demographic, social, historical and clinical features and compared to a similar, non-Veteran sample. RESULTS: Participants were largely male and white, with about half unmarried and half unemployed. They were moderately severely depressed, with about one-third reporting recent suicidal ideation. More than half had chronic and/or recurrent depression. General medical and psychiatric comorbidities were highly prevalent, particularly PTSD. Many had histories of childhood adversity and bereavement. Participants were impaired in multiple domains of their lives and had negative self-worth. LIMITATIONS: These results may not be generalizable to females, and some characteristics may be specific to Veterans of US military service. There was insufficient data on age of clinical onset and depression subtypes, and three novel measures were not psychometrically validated. CONCLUSIONS: Characterizing VAST-D participants provides important information to help clinicians understand features that may optimize "next-step" MDD treatments.


Assuntos
Antidepressivos/uso terapêutico , Transtorno Depressivo Maior/tratamento farmacológico , Transtorno Depressivo Maior/psicologia , Transtorno Depressivo Resistente a Tratamento/tratamento farmacológico , Veteranos/psicologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Antidepressivos/efeitos adversos , Aripiprazol/uso terapêutico , Bupropiona/uso terapêutico , Comorbidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estados Unidos , Adulto Jovem
7.
Psychiatr Rehabil J ; 37(2): 107-9, 2014 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-24708195

RESUMO

OBJECTIVE: To explore whether psychosocial challenges impact effects of vocational rehabilitation in Veterans with Posttraumatic Stress Disorder (PTSD). METHODS: A post hoc exploratory analysis of possible moderators of treatment was conducted on outcomes from a randomized, controlled trial of Individual Placement and Support in Veterans with PTSD. RESULTS: When examining groups within each moderator, there was a greater IPS supportive employment benefit in gaining competitive employment for those with inadequate transportation (number needed to treat [NNT] = 1.5) and inadequate housing (NNT = 1.5) compared with the main finding of the pilot study (NNT = 2.07). Compared with the main finding of the pilot study, there was no greater advantage of IPS for those with adequate transportation (NNT = 2.4) or adequate housing (NNT = 2.4). Compared with the main finding in the pilot study, those without a family care burden had a greater benefit from IPS (NNT = 1.4) and those with family care burden had a reduced treatment effect (NNT = 3.3). CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: These results are exploratory and are not intended to guide clinical decision-making, but rather offer a potentially useful strategy in the design of larger trials of IPS.


Assuntos
Reabilitação Vocacional/métodos , Transtornos de Estresse Pós-Traumáticos/reabilitação , Veteranos/psicologia , Emprego/psicologia , Emprego/estatística & dados numéricos , Readaptação ao Emprego/métodos , Habitação , Humanos , Projetos Piloto , Transtornos de Estresse Pós-Traumáticos/psicologia , Transportes , Veteranos/estatística & dados numéricos
8.
J Correct Health Care ; 20(2): 95-104, 2014 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-24532812

RESUMO

Correctional facilities are a major provider of mental health care throughout the United States. In spite of the numerous benefits of providing care in this setting, clinicians are sometimes concerned about entering into correctional care because of uncertainty in prescribing practices. This article provides an introduction to prescription drug use, abuse, and diversion in the correctional setting, including systems issues in prescribing, commonly abused prescription medications, motivation for and detection of prescription drug abuse, and the use of laboratory monitoring. By understanding the personal and systemic factors that affect prescribing habits, the clinician can develop a more rewarding correctional practice and improve care for inmates with mental illness.


Assuntos
Assistência à Saúde/normas , Transtornos Mentais/tratamento farmacológico , Desvio de Medicamentos sob Prescrição , Prisões/organização & administração , Psicotrópicos/provisão & distribução , Adulto , Assistência à Saúde/economia , Assistência à Saúde/métodos , Humanos , Masculino , Adesão à Medicação/estatística & dados numéricos , Transtornos Mentais/economia , Transtornos Mentais/epidemiologia , Prisões/economia , Prisões/normas , Psicotrópicos/economia , Psicotrópicos/normas , Detecção do Abuso de Substâncias/métodos , Estados Unidos/epidemiologia
9.
Depress Anxiety ; 29(2): 111-22, 2012 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-22495941

RESUMO

BACKGROUND: The co-occurrence of substance use disorder (SUD) and major depressive disorder (MDD) is common and is often thought to impair response to antidepressant therapy. These patients are often excluded from clinical trials, resulting in a significant knowledge gap regarding optimal pharmacotherapy for the treatment of MDD with concurrent SUD. METHODS: In the Combining Medications to Enhance Depression Outcomes study, 665 adult outpatients with chronic and/or recurrent MDD were prospectively treated with either escitalopram monotherapy (escitalopram and placebo) or an antidepressant combination (venalfaxine-XR and mirtazapine or escitalopram and bupropion-SR). Participants with MDD and concurrent SUD (13.1%) were compared to those without SUD (86.9%) on sociodemographic and clinical characteristics at baseline and treatment response at 12- and 28-week endpoints. RESULTS: The participants with MDD and SUD were more likely to be male and have current suicidal thoughts/plans, and had a greater lifetime severity and number of suicide attempts, and a higher number of concurrent Axis I disorders, particularly concurrent anxiety disorders. There were no significant differences between the MDD with or without SUD groups in terms of dose, time in treatment, response or remission at week 12 and 28. Furthermore, no significant differences in response or remission rates were noted between groups on the basis of the presence or absence of SUD and treatment assignment. CONCLUSIONS: Although significant baseline sociodemographic and clinical differences exist, patients with MDD and concurrent SUD are as likely to respond and remit to a single or combination antidepressant treatment as those presenting without SUD.


Assuntos
Antidepressivos/administração & dosagem , Transtorno Depressivo Maior/tratamento farmacológico , Transtornos Relacionados ao Uso de Substâncias/tratamento farmacológico , Adolescente , Bupropiona/administração & dosagem , Doença Crônica , Citalopram/administração & dosagem , Cicloexanóis/administração & dosagem , Diagnóstico Duplo (Psiquiatria) , Quimioterapia Combinada , Humanos , Mianserina/administração & dosagem , Mianserina/análogos & derivados , Mirtazapina , Recidiva , Índice de Gravidade de Doença , Tentativa de Suicídio , Resultado do Tratamento , Cloridrato de Venlafaxina , Adulto Jovem
11.
Acad Psychiatry ; 27(2): 93-9, 2003.
Artigo em Inglês | MEDLINE | ID: mdl-12824109

RESUMO

OBJECTIVE: The authors sought to determine how often psychiatric residents encountered completed suicide, how it affected them, and what supports were available and most useful to them. METHODS: Psychiatric residents completed questionnaires about their encounters with completed suicide during residency. Questionnaire items asked about the resident's relationship to the deceased, the impact of the suicide on the resident, what supports were available and useful to residents, and whether residents had received education about suicide. Postgraduate education directors were similarly surveyed about their programs. RESULTS: Of 197 respondents, 61.4% had encountered one or more completed suicides during their residency. Of the suicides, 61% were by patients and 16.5% by a colleague, friend, or relative; 22.3% of the residents had encountered both. The most common context was suicide by a patient the resident had seen on call or in consultation; next was suicide by a fellow physician. The greatest impact on residents was on their emotional health, followed by how they assess patients and their medicolegal view of psychiatry. Friends and fellow residents were identified as significant supports. Residents were reluctant to use employee assistance programs, citing confidentiality and insurance issues. Only one-third of residents received education on the impact of suicide on trainees. Postgraduate education directors' responses closely reflected those of residents. Only one-third of postgraduate education directors reported having a policy in place in the event of suicide. CONCLUSIONS: Suicide is a commonly encountered, stressful event for trainees. Additional supports, education, and policies should be implemented to address this issue.


Assuntos
Internato e Residência , Psiquiatria/educação , Suicídio , Adulto , Coleta de Dados , Emoções , Feminino , Humanos , Masculino , Relações Médico-Paciente , Apoio Social , Estresse Psicológico
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