Status:
TERMINATED
Mood Stabilizer (MS)+ Antidepressant vs MS + Placebo in Maintenance of Bipolar Disorder.
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
GlaxoSmithKline
Conditions:
Bipolar I Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
Patients with bipolar I disorder (BD) experience depression 3 times more frequently than mania, and antidepressants are prescribed as adjuncts to mood stabilizers in up to 70% of patients. However, no...
Detailed Description
Study Design: The investigators propose a multicentre, randomized, double-blind, placebo-controlled trial in patients with BD who are currently experiencing a depressive episode. The trial will consi...
Eligibility Criteria
Inclusion
- OPEN-LABEL ACUTE TREATMENT PHASE
- Diagnosed with BD, current episode depressed, with a MADRS score ≥ 20 at both the screening and baseline assessments
- The duration of the current depressive episode is ≥ 2 weeks but ≤ 52 weeks
- Taking or initiating treatment with an anti-manic medication at a therapeutic dose. Anti-manic medications and therapeutic doses are: lithium, serum level 0.6-1.4 mEq/L; divalproex, serum level 350-700 mM; risperidone 1-6 mg/day; olanzapine 5-30 mg/day; quetiapine IR or XR 300-900 mg/day; aripiprazole 10-30 mg/day; and ziprasidone 80-160 mg/day. Combinations of these medications as outlined above, or the combination of any of them with lamotrigine 100-400 mg daily, or the combination of a mood stabilizer plus asenapine 5-20 mg/day, are also permitted.
- If taking any other psychoactive medication (other than lorazepam ≤ 4 mg/day or equivalent), is agreeable to tapering and discontinuing it over a period of ≤ 4 weeks
- If female and of childbearing potential, is using an adequate method of contraception.
- Aged 18-70 years, inclusive
- Fluent in English and capable of providing informed consent
- DOUBLE-BLIND MAINTENANCE TREATMENT PHASE
- • Patients meeting all of the following criteria will be eligible to be included in the double-blind study phase:
- Taking escitalopram 10-30 mg/day or bupropion XL 150-450 mg/day, in addition to their anti-manic medication.
- Has adequately tolerated the combination of antidepressant plus mood stabilizer, and is currently in remission for ≥ 2 weeks and ≤ 8 weeks
- If female and of childbearing potential, is using an adequate method of contraception
Exclusion
- OPEN-LABEL ACUTE TREATMENT PHASE
- Has a history of rapid cycling, defined as ≥ 4 mood episodes in the preceding 12 months
- Has current manic, hypomanic, or subsyndromal hypomanic symptoms, defined as a Young Mania Rating Scale (YMRS) score ≥ 8 at the screening or baseline visits
- Has previously been refractory to treatment with both escitalopram and bupropion XL, or has been unable to tolerate both medications due to intolerable side effects or an allergic reaction
- Is taking monoamine oxidase inhibitors, such as phenelzine or tranylcypromine
- Escitalopram is contraindicated in patients taking pimozide or ziprasidone. Patients on pimozide or ziprasidone can participate in the study and will be prescribed bupropion XL
- Bupropion XL is contraindicated in patients taking other preparations containing bupropion, in patients with active eating disorders, including anorexia nervosa and bulimia nervosa; and in patients with seizure disorders. Patients with any of these can still participate in the study and will be prescribed Escitalopram
- 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
- 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
- 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
- Has significant abnormalities on an electrocardiogram
- Is pregnant or lactating
- DOUBLE-BLIND MAINTENANCE TREATMENT PHASE
- Has a history of rapid cycling, defined as ≥ 4 mood episodes in the preceding 12 months
- Has current manic, hypomanic, or subsyndromal hypomanic symptoms, defined as a YMRS score ≥ 8 at the screening or baseline visits
- 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
- 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
- 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.
- Has significant abnormalities on an electrocardiogram
- Is pregnant or lactating
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2020
Estimated Enrollment :
237 Patients enrolled
Trial Details
Trial ID
NCT00958633
Start Date
November 1 2010
End Date
May 20 2020
Last Update
May 15 2025
Active Locations (1)
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1
University of British Columbia
Vancouver, British Columbia, Canada, V6T 2A1