Status:
TERMINATED
Low-Dose Adjunctive Aripiprazole in the Treatment of Bipolar Depression: Double-Blind Placebo-Controlled Pilot Study
Lead Sponsor:
Serge Beaulieu
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Bipolar Disorder
Depressive Episode
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Aripiprazole is a new antipsychotic agent which possesses unique capabilities compared to other antipsychotic agents, especially because of its partial dopaminergic agonistic activity. Moreover, like ...
Eligibility Criteria
Inclusion
- Age : 18-65
- Male or female
- Bipolar Disorder type I
- Current depressive episode (with MADRS ≥ 20 and item 2 (reported sadness) ≥ 3) for a minimum of 2 weeks but ≤ 52 weeks at screening visit and baseline visit)
- If female and of childbearing potential, is using an adequate method of contraception.
- Is treated with a mood stabilizer (lithium and/or valproate)
- Patient is able to give his consent
Exclusion
- Is at high risk of suicide as defined by a score of ≥ 3 to item 10 of MADRS and/or in the clinical opinion of the investigator
- Hypo(mania) episode with YMRS ≥ 8
- Psychotic symptoms as defined by a score of ≥ 4 to item 8 (content) of YMRS and/or in the opinion of the investigator
- Is treated with fluoxetine OR lamotrigine OR carbamazepine OR any antidepressants
- Is treated with risperidone OR olanzapine OR quetiapine OR ziprazidone OR any antipsychotics
- Is pregnant or lactating or absence of contraceptive treatment
- Drug abuse or dependence as per DSM-IV (MINI)
- Unstable medical condition
- Other psychiatric condition, organic brain disorder, unstable and/or untreated medical condition such as hypothyroidism, hyperthyroidism, diabetes, cardiac condition, hypertension
- Deficit in vitamin B12 or folate
- Alcohol or drug abuse
- Rapid cycling (more than 4 mood episodes per year)
- Active or history of difficulty to swallow
- Seizures not currently controlled with medications
- Orthostatic hypotension
- A history of clinically significant cardiovascular disorders and cardiac arrhythmias
- A low white blood cell count
- Known eye disease
- Involuntary, irregular muscle movements, especially in the face
- Known hypersensitivity to aripiprazole and any components of its formulation
- Known lactose intolerance or have hereditary galactose intolerance or glucose-galactose malabsorption, because ABILIFY tablets contain lactose
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01520350
Start Date
February 1 2012
End Date
June 1 2013
Last Update
July 29 2014
Active Locations (1)
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1
Douglas Mental Health University Institute
Montreal, Quebec, Canada, H4H 1R3