Acute Treatment of Bipolar II Depression

Phase 3 Completed 102 enrolled Stanford University National Institute of Mental Health (NIMH) · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This study will compare the medications lithium and lamotrigine (Lamictal®) in treating depression in individuals with bipolar II disorder.

Timeline

Start: 2003-05
Primary completion: 2007-10
Completion: 2007-10

Outcome

Missed primary endpoint

paper Both groups showed significant improvement from baseline to endpoint on the Ham-D(17) (p<0.0001), with no between group differences (p=0.95). PMID 18358540 ↗

Publications

Results Suppes T, Marangell LB, Bernstein IH, Kelly DI, Fischer EG, Zboyan HA, Snow DE, Martinez M, Al Jurdi R, Shivakumar G, Sureddi S, Gonzalez R. A single blind comparison of lithium and lamotrigine for the treatment of bipolar II depression. J Affect Disord. 2008 Dec;111(2-3):334-43. doi: 10.1016/j.jad.2008.02.004. Epub 2008 Mar 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lamotrigine	Small molecule	200 mg	—
Subject	Lithium	Unknown	900 mg	—