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1.
N Engl J Med ; 389(5): 430-440, 2023 Aug 03.
Article in English | MEDLINE | ID: mdl-37530824

ABSTRACT

BACKGROUND: Antidepressants are used to treat acute depression in patients with bipolar I disorder, but their effect as maintenance treatment after the remission of depression has not been well studied. METHODS: We conducted a multisite, double-blind, randomized, placebo-controlled trial of maintenance of treatment with adjunctive escitalopram or bupropion XL as compared with discontinuation of antidepressant therapy in patients with bipolar I disorder who had recently had remission of a depressive episode. Patients were randomly assigned in a 1:1 ratio to continue treatment with antidepressants for 52 weeks after remission or to switch to placebo at 8 weeks. The primary outcome, assessed in a time-to-event analysis, was any mood episode, as defined by scores on scales measuring symptoms of hypomania or mania, depression, suicidality, and mood-episode severity; additional treatment or hospitalization for mood symptoms; or attempted or completed suicide. Key secondary outcomes included the time to an episode of mania or hypomania or depression. RESULTS: Of 209 patients with bipolar I disorder who participated in an open-label treatment phase, 150 who had remission of depression were enrolled in the double-blind phase in addition to 27 patients who were enrolled directly. A total of 90 patients were assigned to continue treatment with the prescribed antidepressant for 52 weeks (52-week group) and 87 were assigned to switch to placebo at 8 weeks (8-week group). The trial was stopped before full recruitment was reached owing to slow recruitment and funding limitations. At 52 weeks, 28 of the patients in the 52-week group (31%) and 40 in the 8-week group (46%) had a primary-outcome event. The hazard ratio for time to any mood episode in the 52-week group relative to the 8-week group was 0.68 (95% confidence interval [CI], 0.43 to 1.10; P = 0.12 by log-rank test). A total of 11 patients in the 52-week group (12%) as compared with 5 patients in the 8-week group (6%) had mania or hypomania (hazard ratio, 2.28; 95% CI, 0.86 to 6.08), and 15 patients (17%) as compared with 35 patients (40%) had recurrence of depression (hazard ratio, 0.43; 95% CI, 0.25 to 0.75). The incidence of adverse events was similar in the two groups. CONCLUSIONS: In a trial involving patients with bipolar I disorder and a recently remitted depressive episode, adjunctive treatment with escitalopram or bupropion XL that continued for 52 weeks did not show a significant benefit as compared with treatment for 8 weeks in preventing relapse of any mood episode. The trial was stopped early owing to slow recruitment and funding limitations. (Funded by the Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT00958633.).


Subject(s)
Bipolar Disorder , Humans , Bipolar Disorder/drug therapy , Bipolar Disorder/diagnosis , Mania , Bupropion/adverse effects , Depression , Escitalopram , Canada , Neoplasm Recurrence, Local/drug therapy , Antidepressive Agents/adverse effects , Double-Blind Method , Treatment Outcome
4.
Indian J Psychiatry ; 60(1): 84-89, 2018.
Article in English | MEDLINE | ID: mdl-29736068

ABSTRACT

CONTEXT: Mental health has currently shifted focus from "deficit" to strength-based approaches such as Resilience. Coping styles and personality factors have been well studied in Wives of persons with Alcoholism (WopA) but not Resilience. Alcohol dependence in spouse is seen as an adversity. AIMS: To evaluate Resilience in the WopA and explore its relationship with marital quality and clinical variables of Alcohol Dependence in their husbands. SETTINGS AND DESIGN: A cross-sectional study in a tertiary care hospital in Bangalore, Karnataka. SUBJECTS AND METHODS: WopA (n=34) between 25-55 years, were assessed for Resilience using Resilience Scale for Adults (RSA), while marital quality was assessed using Marital Quality Scale (MQS). The Severity of Alcohol Dependence, Age of onset of Initiation, Age of onset of Problem Drinking, and Age of onset of Dependence were evaluated in their husbands. STATISTICAL ANALYSIS: Independent sample t-test, Chi-square test, and Pearson's correlation were used. RESULTS: Majority of the WopA (82%) scored low on the RSA. Low Resilience (LR) WopA scored significantly lower on all factors of RSA except the perception of future; in comparison to High Resilience (HR) WopA. Additionally, the LR WopA reported significantly poorer marital quality. CONCLUSIONS: Most WopA had low Resilience. LR WopA also had significantly poor marital quality. These findings need to be studied further in a larger population with culturally appropriate scales. The low scoring Resilience factors amongst WopA may be utilized in strength-based psychotherapeutic approaches. There is a need to improve the understanding of Resilience and its assessment in this population.

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