Status:
COMPLETED
Bipolar II Depression: Lithium, SSRI, or the Combination
Lead Sponsor:
Lindner Center of HOPE
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
University of California, Los Angeles
Conditions:
Bipolar Disorder
Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This study will compare the safety and effectiveness of a mood stabilizing medication, an antidepressant medication, and a combination of both medications to treat symptoms of bipolar type II depressi...
Detailed Description
Bipolar type II depression (BD II) is a less severe type of bipolar disorder. BD II is characterized by one or more depressive episodes and at least one hypomanic episode. During hypomanic episodes, p...
Eligibility Criteria
Inclusion
- Meets DSM-IV criteria for bipolar type II disorder by Structured Clinical Interview for DSM-IV (SCID)
- Meets DSM-IV criteria for current depressive episode
- Inventory of Depressive Symptomology (IDS-C) score greater than 22
- Clinical Global Impression Scale for Bipolar Illness (CGI-BP) depression subscale score greater than 3 (mildly ill or greater) and mania subscale score of 1 (not ill)
- Young Mania Rating Scale (YMRS) score less than 8
- Willing to discontinue antidepressant medication
- Considered stable and does not require adjustments in treatment for other conditions or illnesses
- Willing to use an effective form of birth control throughout the study
- Speaks English
Exclusion
- Pregnant or breastfeeding
- Unsuccessfully treated for more than 6 weeks with sertraline or lithium for depression
- Suicidal
- Significant alcohol or substance abuse or dependence within 3 months of study entry
- Diagnosed with Axis II borderline personality disorder
- Psychotic
- Organic mood disorder (e.g., head trauma or cerebrovascular accident preceding mood episode)
- Active hepatitis, liver failure, or kidney failure
- Creatinine greater than 1 mg/dL
- Liver function tests greater than 3 times the upper limit of normal
- Abnormal thyroid-stimulating hormone
- Unstable medical condition
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT00276965
Start Date
September 1 2006
End Date
July 1 2012
Last Update
May 10 2013
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
UCLA
Los Angeles, California, United States, 90095
2
Stanford University - Bipolar Research Program
Palo Alto, California, United States, 94304
3
Lindner Center of HOPE, affliated with University of Cincinnati Medical Center
Mason, Ohio, United States, 45040