Phase 4
N=86
Maintenance Treatment of Bipolar Depression
Bipolar Disorder · Depression
Bottom Line
View on ClinicalTrials.gov: NCT00183469 ↗Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Mania Rating Scale — 4.54; 5.57 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lamotrigine (Drug); Divalproex (DIV) ER (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mania Rating Scale |
4.54; 5.57 | — |
Summary
This study will compare two different antidepressant treatment regimens to determine which is more effective in reducing symptoms of bipolar depression.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of bipolar disorder I or II
- Experiencing symptoms of depression at study entry OR have experienced symptoms of depression within 6 months prior to study entry
- Willing to use acceptable methods of contraception
- Parent or guardian willing to provide informed consent, if applicable
Exclusion Criteria
- History of liver disease
- History of substance abuse
- Previous treatment with lamotrigine or divalproex
- Lamotrigine or divalproex intolerance
Data sourced from ClinicalTrials.gov (NCT00183469). 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.