Efficacy of antidepressants in preventing recurrence of mood episodes in bipolar disorder
- Conditions
- Health Condition 1: null- Bipolar disorderHealth Condition 2: F313- Bipolar disorder, current episodedepressed, mild or moderate severity
- Registration Number
- CTRI/2015/01/005441
- Lead Sponsor
- Canadian Institutes of Health Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 156
Patients meeting all of the following criteria will be eligible to be included in the double-blind study phase:
1.Taking escitalopram 10-30 mg/day or bupropion XL 150-450 mg/day, in addition to either a mood stabilizing medication (lithium, serum level 0.6-1.2 mEq/L, divalproex, serum level 350-700 mM or carbamazepine, serum level 20-50 umol/L), an SGA (risperidone 1-6 mg/day; olanzapine 5-30 mg/day; quetiapine IR or XR 150-900 mg/day; aripiprazole 10-30 mg/day; or ziprasidone 80-160 mg/day), two mood stabilizers, a mood stabilizer plus an SGA (including asenapine 5-20 mg/day), or a mood stabilizer or SGA plus lamotrigine (100-400 mg/day).
2.Has adequately tolerated the combination of antidepressant plus mood stabilizer, and is currently in remission for >= 2 weeks and <= 8 weeks.
3.If female and of childbearing potential, is using an adequate method of contraception.
Patients meeting any of the following criteria will be excluded from the double-blind study phase:
1.Has a history of rapid cycling, defined as >= 4 mood episodes in the preceding 12 months.
2.Has current manic, hypomanic, or subsyndromal hypomanic symptoms, defined as a YMRS score >= 8 at the screening or baseline visits.
3.Has active substance dependence, other than caffeine or nicotine dependence, in the preceding 3 months. Otherwise, patients with comorbid substance abuse or other comorbid psychiatric illnesses will be eligible to participate in the study.
4.Is at high risk for suicide, as defined by a score of >= 4 on the suicide item of the MADRS, or in the opinion of the investigator.
5.Has an unstable medical illness, as defined by a change in medication or other treatment in the past 4 weeks, or in the opinion of the investigator.
6.Has significant abnormalities on an electrocardiogram.
7.Is pregnant or lactating.
8.Has experienced an episode of mania, hypomania, or a mixed episode during antidepressant treatment of the acute depression, defined as a YMRS score of >= 16 at any open-label study visit, or in the opinion of the study psychiatrist.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method In clinically representative patients with bipolar disorder (BD) depression who respond to acute treatment with escitalopram or bupropion XL in combination with anti-manic medication(s), does continuing antidepressant treatment for 12 months reduce the risk of relapse into any mood episode, including depression, mania, and hypomania, compared to discontinuing the antidepressant and substituting it with placebo after 2 months?Timepoint: Open label phase up to 16 weeks and double-blind phase up to 52 weeks
- Secondary Outcome Measures
Name Time Method â?¢Does 12-month antidepressant treatment reduce the risk of relapse into depression? <br/ ><br>â?¢Does 12-month antidepressant treatment increase the risk of mania / hypomania? <br/ ><br>â?¢Do rates of subsyndromal symptoms and adverse events differ between patients who continue antidepressant treatment compared to those who stop the antidepressant after 2 months? <br/ ><br>â?¢Does antidepressant treatment improve overall health and quality of life for patients? <br/ ><br>Timepoint: 16 weeks of open label and 52 weeks of double-blind