RecruitingPhase 4ACTRN12605000666628

Efficacy of 8 weeks open label aripiprazole as augmentation therapy in Bipolar II disorder

Sponsor

Bristol-Myers Squibb Pharmaceuticals

Enrollment

25 participants

Start Date

Jan 8, 2004

Study Type

Interventional

Conditions

Study approved

Sex: Both males and femalesMin Age: 18 Yearss

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.

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.

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Addition of trial medication (aripiprazole) to existing treatment for a period of 8 weeks

Australia

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ACTRN12605000666628