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| Sponsored by: |
National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00276965 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder Depression |
Drug: Sertraline Drug: Lithium carbonate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment |
| Official Title: | 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 |
| Estimated Enrollment: | 70 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | September 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
Participants will take lithium only.
|
Drug: Lithium carbonate
Lithium or placebo for lithium starting at 150 mg per day; target dose of 900mg per day. Maximum dose based on clinical response and serum levels (maximum serum level of 1.2 mEq/L).
|
|
B: Experimental
Participants will take lithium and sertraline.
|
Drug: Sertraline
Sertraline or placebo for sertraline starting at 25 mg per day, up to maximum of 200 mg per day
Drug: Lithium carbonate
Lithium or placebo for lithium starting at 150 mg per day; target dose of 900mg per day. Maximum dose based on clinical response and serum levels (maximum serum level of 1.2 mEq/L).
|
|
C: Experimental
Participants will take sertraline only.
|
Drug: Sertraline
Sertraline or placebo for sertraline starting at 25 mg per day, up to maximum of 200 mg per day
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Susan L. McElroy, MD | 513-536-0700 | susan.mcelroy@lindnercenter.org |
| Contact: Brian E Martens, MS | 513-536-0720 | brian.martens@lindnercenter.org |
| United States, California | |
| UCLA | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact 310-794-6663 | |
| Principal Investigator: Lori Altshuler, MD | |
| Stanford University - Bipolar Research Program | Not yet recruiting |
| Palo Alto, California, United States, 94304 | |
| Contact: Mylea Charvat 650-849-0161 tsuppes@stanford.edu | |
| Contact: Grace Fisher (650) 493-5000 ext 67570 | |
| Principal Investigator: Trisha Suppes, MD, PhD | |
| United States, Ohio | |
| Lindner Center of HOPE, affliated with University of Cincinnati Medical Center | Recruiting |
| Mason, Ohio, United States, 45040 | |
| Contact: Brian Martens, MS, LSW 513-536-0720 brian.martens@lindnercenter.org | |
| Principal Investigator: Sue McElroy, MD | |
| Principal Investigator: | Susan L. McElroy, MD | Lindner Center of HOPE, University of Cincinnati Medical Center |
More Information
| Responsible Party: | Experimental Therapeutics Branch, NIMH ( Mi Hillefors, MD, PhD, Program Officer ) |
| Study ID Numbers: | R01 MH074707, DATR A5-ETMA |
| Study First Received: | January 12, 2006 |
| Last Updated: | October 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00276965 |
| Health Authority: | United States: Federal Government |
|
Bipolar II Depression |
|
Affective Disorders, Psychotic Depression Mental Disorders Bipolar Disorder Mood Disorders Sertraline |
Lithium Carbonate Psychotic Disorders Depressive Disorder Serotonin Lithium Behavioral Symptoms |
|
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Enzyme Inhibitors |
Antimanic Agents Antipsychotic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Therapeutic Uses Central Nervous System Agents Antidepressive Agents |
