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

Summary

Study approved


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a medicine called aripiprazole, used as an add-on treatment, can help stabilise mood in people with Bipolar I or Bipolar II disorder. Many people with bipolar disorder need more than one medication to keep their mood stable. This 8-week open-label study will see how well aripiprazole works when added to a person's existing mood-stabilising treatment. You may be eligible if: - You are 18 years or older - You have been diagnosed with Bipolar I or Bipolar II disorder - You have had at least one hypomanic episode in the past 12 months - Your treating doctor feels your mood is currently unstable and you need an additional mood stabiliser - You are using an effective form of contraception (if you are a woman who could become pregnant) You may NOT be eligible if: - You have been on another antipsychotic medicine (other than aripiprazole) in the last 7 days before Week 4 - You have received a depot (long-acting injection) antipsychotic in the past 8 weeks - You have had ECT (electroconvulsive therapy) in the past 3 months - You are pregnant, breastfeeding, or planning to become pregnant - You have a main diagnosis of major depressive disorder, schizophrenia, or organic mental disorder - You have current alcohol or substance dependence - You are considered to be at significant risk of suicide Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

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

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


Locations(1)

Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12605000666628


Related Trials