drugset / Trial / NCT02989727

Melancholic Symptoms in Bipolar Depression and Responsiveness to Lamotrigine

NCT02989727 ↗

Phase 4 Completed 150 enrolled University of Saskatchewan GlaxoSmithKline · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to determine if patients with melancholic bipolar II depression are more responsive to lamotrigine than patients with non-melancholic bipolar II depression. To do this, the investigators will re-analyze a previous clinical trial that evaluated lamotrigine as a treatment for bipolar II depression (GSK-SCA100223; NCT00274677).

Timeline

Start
2003-11
Primary completion
2005-08
Completion
2017-12

Outcome

Mixed primary results

registry analysis (superiority test); Lamotrigine - Melancholic Depression vs Placebo - Melancholic Depression vs Lamotrigine - Nonmelancholic Depression vs Placebo - Nonmelancholic Depression; p = .59 NCT02989727 ↗

registry analysis (superiority test); Lamotrigine - Melancholic Depression vs Placebo - Melancholic Depression vs Lamotrigine - Nonmelancholic Depression vs Placebo - Nonmelancholic Depression; p = .84 NCT02989727 ↗

registry analysis (superiority test); Lamotrigine - Melancholic Depression vs Placebo - Melancholic Depression; p = .08 NCT02989727 ↗

registry analysis (superiority test); Lamotrigine - Nonmelancholic Depression vs Placebo - Nonmelancholic Depression; p = .53 NCT02989727 ↗

registry analysis (superiority test); Lamotrigine - Melancholic Depression vs Placebo - Melancholic Depression; p = .02; Cox Proportional Hazard 1.27; Regression, Cox NCT02989727 ↗

registry analysis (superiority test); Lamotrigine - Nonmelancholic Depression vs Placebo - Nonmelancholic Depression; p = .73; Cox Proportional Hazard 1.05; Regression, Cox NCT02989727 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Lamotrigine Small molecule 200 mg —