Status:
COMPLETED
Acute Treatment of Bipolar II Depression
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
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, ther...
Eligibility Criteria
Inclusion
- Current diagnosis of bipolar II disorder
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00074776
Start Date
May 1 2003
End Date
October 1 2007
Last Update
July 23 2012
Active Locations (1)
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1
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390-9121