Bipolar II Depression: Lithium, SSRI, or the Combination

Completed · Phase 3 · Has a placebo group

Conditions studied: Bipolar Disorder, Depression

In brief

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.

Key facts

Study ID

NCT00276965

Run by

Lindner Center of HOPE

People needed

139

Starts

2006-09-01

Expected to finish

2012-07-01

Last updated by the study team

2013-05-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCLA — Los Angeles, California, United States
• Stanford University - Bipolar Research Program — Palo Alto, California, United States
• Lindner Center of HOPE, affliated with University of Cincinnati Medical Center — Mason, Ohio, United States

Full record on ClinicalTrials.gov

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