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Comparing 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
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.
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, people experience especially energetic or anxious moods, and their thoughts are more sporadic than usual, but they do not experience the severity of mania. Symptoms of BD II are known to impair daily functioning as well as cause distress and even suicide. Antidepressant medication alone is not recommended for people with bipolar disorder because manic symptoms usually worsen. It is unknown whether the same recommendation should apply to people with BD II. Sertraline is a selective serotonin reuptake inhibitor (SSRI) antidepressant that increases levels of serotonin, helping the brain to maintain mental stability. It is often used to treat depression, panic attacks, and other disorders. Lithium is a mood stabilizing medication that decreases abnormal brain activity and is used to treat and prevent recurring episodes of mania in people with bipolar disorders. This study will evaluate the effectiveness of lithium alone, sertraline alone, and lithium with sertraline to treat symptoms of BD II. Participation in this double-blind study will last up to 18 weeks. Participants will be randomly assigned to receive either lithium, sertraline, or lithium and sertraline. Both medications will initially be given at a low dose and then gradually increased over 2 weeks. For the remainder of the study, dosages will be adjusted as necessary. Study visits will occur every week for the first 6 weeks and then every other week for the remaining 10 weeks. During all study visits, participants will complete a psychiatric assessment and questionnaires about their current mood and any treatment side effects. Urine and blood collection may occur at selected times during the study.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
September 1, 2006
Primary Completion Date
March 1, 2012
Completion Date
July 1, 2012
Last Updated
May 10, 2013
139
ACTUAL participants
Sertraline
DRUG
Lithium carbonate
DRUG
Lead Sponsor
Lindner Center of HOPE
Collaborators
NCT07360600
NCT06793397
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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