A Phase IV Study of the Safety and Efficacy 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

Official Title: “A Multicenter, Double-blind, Study of 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”

Efficacy of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients with Recent Manic or Mixed Episode

Intervention(s) in this Clinical Trial

• Drug: Lamotrigine + Aripiprazole
  • Tablets, Oral, once daily, Phase 1 (all subjects) - up to 24 weeks; Phase 2 - up to 52 weeks Lamotrigine 100-200 mg/day Aripiprazole 10-30 mg/day
• Drug: Lamotrigine + Placebo
  • Tablets, Oral, once daily, Phase 2 - up to 52 weeks Lamotrigine 100-200 mg/day placebo 0 mg/day

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A1
  • Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole ; Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole
• Placebo Comparator: A2
  • Phase 2 Double-Blind Treatment: Lamotrigine + Placebo

Primary Measures

• Proportion of Participants Not Experiencing Relapse Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2)
  • Time Frame: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
    Safety Issue?: No

Secondary Measures

• Proportion of Participants Not Experiencing Relapse (Manic, Mixed, Depressive) in the Double-blind Relapse Assessment Phase Phase 2
  • Time Frame: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
    Safety Issue?: No
• Proportion of Participants Not Experiencing a Depressive Relapse in the Double-blind Relapse Assessment Phase (Phase 2)
  • Time Frame: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
    Safety Issue?: No
• Proportion of Participants Without Discontinuation for Any Reason in the Double-blind Relapse Assessment Phase (Phase 2)
  • Time Frame: Weeks 0, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
    Safety Issue?: No
• Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Medication, Treatment-Emergent AEs and Treatment-Emergent Extrapyramidal Syndrome (EPS)-Related AEs
  • Time Frame: Throughout Phase 2 (up to 52 weeks)
    Safety Issue?: Yes
• Adjusted Mean Change From Baseline in Body Weight, Phase 2
  • Time Frame: Baseline, Week 52
    Safety Issue?: Yes
• Number of Participants Showing Clinically Relevant Weight Loss by Study Week
  • Time Frame: Weeks 12, 24, 36, 52
    Safety Issue?: Yes
• Number of Participants Showing Clinically Relevant Weight Gain by Study Week
  • Time Frame: Weeks 12, 24, 36, 52
    Safety Issue?: Yes
• Adjusted Mean Change From Baseline in BMI by Study Week
  • Time Frame: Baseline, Weeks 12, 24, 36, 52
    Safety Issue?: Yes
• Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities Occurring During Double-Blind Treatment
  • Time Frame: Throughout the study, up to Week 52
    Safety Issue?: Yes
• Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities Occurring During Double-Blind Treatment
  • Time Frame: Up to 52 Weeks
    Safety Issue?: Yes
• Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities Occurring During Double-Blind Treatment (Phase 2)
  • Time Frame: Throughout Phase 2 of the study, up to Week 52
    Safety Issue?: Yes
• Summary of Concomitant Medications, Phase 1
  • Time Frame: Phase 1 (9 to 24 Week Single-blind Stabilization Phase)
    Safety Issue?: Yes
• Summary of Concomitant Medications, Phase 2
  • Time Frame: Phase 2 (52 Week Double-blind Relapse Assessment Phase)
    Safety Issue?: Yes
• Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score
  • Time Frame: Baseline, Weeks 8, 24, 36, 52
    Safety Issue?: Yes
• Adjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score
  • Time Frame: Baseline, Weeks 8, 24, 36, 52
    Safety Issue?: Yes
• Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment,
  • Time Frame: Baseline, Weeks 8, 24, 36, 52
    Safety Issue?: Yes

Inclusion Criteria:

• Men and women ≥ 18 years of age meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision) (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 years duration
• Treated with aripiprazole within the past 3 months
• Allergic, intolerant, hypersensitive or refractory to aripiprazole or lamotrigine

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Bristol-Myers Squibb Industry

Overall Clinical Trial Officials and Contacts

Bristol-Myers Squibb Study Director Bristol-Myers Squibb  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00277212

Study ID Number: CN138-392 ST

ClinicalTrials.gov Identifier: NCT00277212

Health Authority: United States: Food and Drug Administration

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