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.
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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)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12605000666628
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