Acute Treatment of Bipolar II Depression

Phase 3

Completed

• Conditions: Bipolar Disorder
• Interventions: Drug: Lithium; Drug: Lamotrigine

• Registration Number: NCT00074776
• Lead Sponsor: Stanford University

Brief Summary

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

Detailed Description

Bipolar II disorder (BDII) is a serious condition characterized by depressive and hypomanic episodes. The disability and suicide risk associated with BDII is equal to bipolar I disorder. However, there are no clinical trials for BDII, nor is the treatment of BDII addressed in current treatment guidelines. Data suggest that Li and LTG may be effective treatment options for BDII. This study will determine the safety, effectiveness, and tolerability of the two drugs in people with BDII.

Participants in this study will be randomly assigned to receive either Li or LTG for 16 weeks. Participants will be assessed every 2 weeks. One week after study completion, participants will have a follow-up visit. Measures of depression, mania, quality of life, functioning, and participant satisfaction will be taken.

Study Timeline

• Study Start: 2003-05
• Study First Submitted: 2003-12-19
• Study First Submitted QC: 2003-12-19
• Study First Posted: 2003-12-22
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-19
• Last Update Posted: 2012-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Current diagnosis of bipolar II disorder

Exclusion Criteria

• Use of lithium or lamotrigine
• Intolerance to lithium or lamotrigine
• Substance abuse or dependence within the last month
• Suicidal thoughts
• Unstable medical conditions
• Pregnancy or breast-feeding
• Stable on current medications
• Use of fluoxetine (Prozac) within 2 weeks of study
• Require an antipsychotic medication
• Do not speak or read English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 Lithium	Lithium	-
2 Lamotrigine	Lamotrigine	-

Primary Outcome Measures

Name	Time	Method
Change in depression symptoms, as measured by the Hamilton Rating Scale for Depression	Measured at baseline and Week 16

Secondary Outcome Measures

Name	Time	Method
Incidence and severity of hypomanic and depressive symptoms	Measured at baseline and Week 16
Medication tolerability, response (defined as a 50% reduction on the Ham-D), and remission (defined as Ham-D or MADRS score less than 12)	Measured at baseline and Week 16
Switch into hypomania, defined as a CGI-BP Mania severity score of 4 or greater	Measured at baseline and Week 16

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center at Dallas; 🇺🇸 Dallas, Texas, United States