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

Phase 4

Recruiting

• Conditions: Bipolar II Disorder; Neurological - Other neurological disorders

• Registration Number: ACTRN12605000666628
• Lead Sponsor: Bristol-Myers Squibb Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified