Phase 4
N=787
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
Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00277212 ↗Enrolled (actual)
787
Serious AEs
4.1%
Results posted
Oct 2010
Primary outcome: Primary: Proportion of Participants Not Experiencing Relapse Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2) — 1.00; 1.00; 0.98; 0.98 Proportion of Participants — p=0.058
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lamotrigine + Aripiprazole (Drug); Lamotrigine + Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants Not Experiencing Relapse Through Week 52 in the Double-Blind Relapse Assessment Phase (Phase 2) |
1.00; 1.00; 0.98; 0.98; 0.97; 0.96 | 0.058 |
| SECONDARY Proportion of Participants Not Experiencing Relapse (Manic, Mixed, Depressive) in the Double-blind Relapse Assessment Phase Phase 2 |
1.00; 1.00; 0.96; 0.95; 0.91; 0.91 | 0.055 |
| SECONDARY Proportion of Participants Not Experiencing a Depressive Relapse in the Double-blind Relapse Assessment Phase (Phase 2) |
1.00; 1.00; 0.98; 0.98; 0.94; 0.95 | 0.381 |
| SECONDARY Proportion of Participants Without Discontinuation for Any Reason in the Double-blind Relapse Assessment Phase (Phase 2) |
0.95; 0.99; 0.90; 0.91; 0.84; 0.84 | 0.295 |
| SECONDARY 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 |
0; 0; 9; 5; 0; 0 | — |
| SECONDARY Adjusted Mean Change From Baseline in Body Weight, Phase 2 |
-1.81; 0.43 | 0.001 sig |
| SECONDARY Number of Participants Showing Clinically Relevant Weight Loss by Study Week |
7; 9; 8; 9; 10; 6 | 0.073 |
| SECONDARY Number of Participants Showing Clinically Relevant Weight Gain by Study Week |
2; 4; 3; 10; 5; 14 | 0.007 sig |
| SECONDARY Adjusted Mean Change From Baseline in BMI by Study Week |
30.77; 30.13; -0.39; -0.03; -0.60; 0.14 | 0.467 |
| SECONDARY Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities Occurring During Double-Blind Treatment |
1; 1; 2; 0; 1; 0 | — |
| SECONDARY Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities Occurring During Double-Blind Treatment |
3; 1; 7; 5; 3; 0 | — |
| SECONDARY Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities Occurring During Double-Blind Treatment (Phase 2) |
3; 0; 2; 1; 0; 0 | — |
| SECONDARY Summary of Concomitant Medications, Phase 1 |
550; 2; 1; 3; 98; 12 | — |
| SECONDARY Summary of Concomitant Medications, Phase 2 |
120; 132; 1; 0; 21; 25 | — |
| SECONDARY Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score |
10.59; 10.58; -0.20; 0.05; -0.21; 0.03 | 0.971 |
| SECONDARY Adjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score |
0.21; 0.14; -0.05; 0.06; -0.01; 0.04 | 0.458 |
| SECONDARY Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment, |
0.22; 0.27; -0.12; 0.04; -0.09; -0.06 | 0.435 |
Summary
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00277212). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.