Duration of Adjunctive Antidepressant Maintenance in Bipolar I Depression.

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.).

Determinants of family functioning in caregivers of persons with obsessive-compulsive disorder.

BACKGROUND: Obsessive-compulsive disorder (OCD) is known to cause significant burden to patients and their caregivers. However, there is limited data on its impact on family functioning, especially from families with an adult member having OCD. METHODS: Four hundred subjects, which included treatment-seeking adult OCD patients (n = 200) and their caregivers (n = 200) were recruited. Patients were evaluated using the Mini International Neuropsychiatric Interview (MINI) and the Yale-Brown Obsessive-Compulsive Scale (YBOCS). Caregivers were evaluated using the MINI, the Caregiver Strain Index (CSI), the Hamilton Anxiety Rating Scale (HAM-A), the Hamilton Depression Rating Scale (HAM-D), the Socio-Occupational Functioning Assessment Scale (SOFAS), the Family Accommodation Scale (FAS) and the Connor-David Resilience scale (CD-RISC) in a cross-sectional interview. Family functioning was measured using the OCD Family Functioning (OFF) Scale. Structural equation modeling (SEM) was carried out to evaluate the relationships between the patient and caregiver variables to predict family functioning. RESULTS: From the best-fitting path model, we ascertained that OCD symptoms did not have a direct relationship with family dysfunction. Their effects were in turn was mediated by family accommodation, anxiety, caregiver stress/burden and depression. "Contamination & washing" was the only significant symptom dimension within the model. Caregiver resilience was found to predict only their individual functioning, and not family functioning. LIMITATIONS: Study sample included patients from a tertiary care OCD service, only one caregiver from each patient's family was interviewed. CONCLUSIONS: Evaluating family functioning, addressing it as part of interventional modules for patients and caregivers may help improving treatment outcomes.