None listed
Conditions
Brief summary
Study approved
Interventions
Addition of trial medication (aripiprazole) to existing treatment for a period of 8 weeks
Sponsors
Bristol-Myers Squibb Pharmaceuticals
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A DSM-IV diagnosis of Bipolar I disorder, orA diagnosis of Bipolar II (with 2 days hypomania rather than the 4 day minimum as defined by DSM-IV); Mood episodes over the previous 12 months (one hypomania); Regarded as being unstable by their treating clinician to warrant an additional mood stabiliser;Female patients of childbearing potential must use a medically accepted means of contraception;Provide written informed consent;Able to understand and comply with the requirements of the study.
Exclusion criteria
Use of any prohibited medication, including antipsychotic meds other than aripiprazole, within 7 days of Week 4Use of depot antipsychotics during last 8 weeks. ECT within past 3 monthsPregnancy or lactation, or intention to become pregnantUnstable or inadequately treated clinically significant medical illness, as judged by the investigatorCurrent DSM-IV diagnosis of MDD, schizophrenia or schizoaffective disorder or organic mental disorder or substance or alcohol dependence at enrolment. Co-morbid anxiety disorder may be includedJudged to be at significant risk for suicide.
Outcome results
None listed