Acute Treatment of Bipolar II Depression

Condition(s) targeted: Bipolar Depression

Intervention: Lithium (Drug); Lamotrigine (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: National Institute of Mental Health (NIMH)

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

Official title: Acute Treatment of Bipolar II Depression

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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.

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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

University of Texas Southwestern Medical Center at Dallas, Dallas, Texas 75390-9121, United States

Starting date: May 2003
Last updated: February 20, 2007