Bipolar II Depression: Lithium, SSRI, or the Combination

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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 depression.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lindner Center of HOPE
• Collaborators: National Institute of Mental Health (NIMH); Stanford University; University of California, Los Angeles
• Treatments: Lithium Carbonate; Sertraline

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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