Phase 4 Completed N=86 Randomized Quadruple-blind Treatment

Maintenance Treatment of Bipolar Depression

Bipolar Disorder · Depression

Source: ClinicalTrials.gov NCT00183469 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2015

Primary outcomePrimary: Mania Rating Scale — 4.54; 5.57 units on a scale

Summary

This study will compare two different antidepressant treatment regimens to determine which is more effective in reducing symptoms of bipolar depression.

Outcome Measures

Outcome	Result	p-value
PRIMARY Mania Rating Scale	4.54; 5.57	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.