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Insulin - Mixed |
Humalog Mix 75/25; Humulin 50/50; Humulin 70/30; Iletin II Mixed; Novolin 70/30; NovoLog Mix |
Clinical Trial: A Multicenter, Double-Blind, Study on the Efficacy and Safety of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With a Recent Manic or Mixed Episode
This study is not yet open for patient recruitment.
Verified by Bristol-Myers Squibb January 2006
|
Purpose
The purpose of this study is to learn whether outpatients with Bipolar Mania who are treated with combination therapy of aripiprazole and lamotrigine can achieve stable symptoms compared to patients treated with placebo plus lamotrigine.
| Condition | Intervention | Phase |
|---|---|---|
| Bipolar I Disorder With a Recent Manic or Mixed Episode | Drug: aripiprazole in combination with lamotrigine | Phase IV |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Further study details as provided by Bristol-Myers Squibb:
Primary Outcomes: The primary efficacy measure will be the time from randomization to relapse to a manic or mixed episode
Secondary Outcomes: - Time to any relapse; - Time to depressive relapse; - 52 week completers
Expected Total Enrollment: 635
Secondary Outcomes: - Time to any relapse; - Time to depressive relapse; - 52 week completers
Expected Total Enrollment: 635
Study start: December 2005
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Men and women ≥ 18 of age meeting DSM-IV-TR criteria for Bipolar I Disorder, recently experiencing a manic or mixed episode with a history of one or more manic or mixed episodes of sufficient severity to require treatment with a mood stabilizer or antipsychotic
Exclusion Criteria:
- First manic episode
- Current manic or mixed episode with > 2 yr duration
- Treated with aripiprazole within past 3 months
- Allergic, intolerant, hypersensitive or refractory to aripiprazole or lamotrigine
Please refer to this study by ClinicalTrials.gov identifier NCT00277212
More Information
Study ID Numbers: CN138-392 ST
Last Updated: January 13, 2006
Record first received: January 13, 2006
ClinicalTrials.gov Identifier: NCT00277212
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-17
Last Updated: January 13, 2006
Record first received: January 13, 2006
ClinicalTrials.gov Identifier: NCT00277212
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-17
Resources
- Humalog Mix 75/25 (Drug Digest)
- Humulin 50/50 (Drug Digest)
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