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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00667745 |
This study will evaluate whether lithium included as part of optimized medication treatment improves overall level of illness, symptoms of mania and depression, and quality of life in people with bipolar disorder.
Condition | Intervention | Phase |
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Bipolar Disorder |
Drug: Lithium Carbonate Drug: Optimized Treatment (OPT) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment |
Official Title: | Lithium Use for Bipolar Disorder (LiTMUS): A Randomized Controlled Effectiveness Trial |
Estimated Enrollment: | 264 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive lithium plus optimized medication treatment, as needed.
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Drug: Lithium Carbonate
Lithium will be started at 300 mg and then increased to 600 mg after 3 days. Lithium doses will be maintained at 600 mg per day for 8 weeks, but may be adjusted after that time as needed up to a serum level of 1.2 mEq/L.
Drug: Optimized Treatment (OPT)
The foundation of OPT is to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines.
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2: Active Comparator
Participants will only receive optimized medication treatment, as needed; lithium will not be used.
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Drug: Optimized Treatment (OPT)
The foundation of OPT is to maintain treatment that will typically include at least one FDA-approved mood stabilizer other than lithium (e.g., divalproex, carbamazepine, risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone) and to follow the recommendations summarized in the evidence-based stages of the Texas Implementation of Medication Algorithm (TIMA) revised guidelines.
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Bipolar illness, a brain disorder that causes dramatic changes in a person's mood and energy, affects about 2.6% of adults in the United States. Bipolar disorder is characterized by cyclical periods of extreme highs and lows, known as episodes of mania and depression. A person undergoing an episode of mania often experiences euphoric moods, increased energy, and aggressive behaviors, while a person in a depressed state often experiences low moods, lack of energy, and feelings of sadness. Lithium is a widely used mood stabilizing medication that has been shown to reduce the occurrence and intensity of manic episodes and may lessen depressive episodes as well. Including lithium as a part of a personalized medication treatment approach may be the most effective means of improving symptoms of bipolar disorder. This study will evaluate whether lithium included as part of optimized medication treatment improves overall level of illness, symptoms of mania and depression, and quality of life in people with bipolar disorder.
Participation in this study will last 6 months. All participants will first undergo initial assessments that will include an interview and questionnaires to confirm a diagnosis of bipolar disorder, vital sign measurements, a blood draw, and if female, a pregnancy test. Eligible participants will then be assigned randomly to receive either optimized medication plus lithium or optimized medication without lithium. Participants in both groups will undergo 6 months of monitored treatment with their medication regimens, as prescribed by their study doctor. Participants will attend study visits every 2 weeks for the first 8 weeks and then once a month for 4 more months. These visits will last between 45 and 60 minutes and will include medication adjustments and questions about symptoms, side effects, and quality of life.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Louisa G. Sylvia, PhD | 617-643-4804 | lsylvia2@partners.org |
United States, California | |
Stanford University | Recruiting |
Stanford, California, United States, 94035-5723 | |
Contact: Shelley Hill 650-498-4801 shill@stanford.edu | |
Principal Investigator: Terence Ketter, MD | |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Christine Kansky, BA 617-726-7591 ckansky@partners.org | |
Principal Investigator: Dan Iosifescu, MD | |
United States, Ohio | |
Case Western Reserve University | Recruiting |
Cleveland, Ohio, United States, 44106 | |
Contact: Carla Conroy 216-844-2871 carla.conroy@Uhhospitals.org | |
Principal Investigator: Joseph Calabrese, MD | |
United States, Pennsylvania | |
University of Pennsylvania | Not yet recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Marna Barnett, PhD 215-898-4301 msb@mail.med.upenn.edu | |
Principal Investigator: Michael Thase, MD | |
University of Pittsburgh Medical Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Luann Shutt 412-246-5762 shuttls@upmc.edu | |
Principal Investigator: Edward Friedman, MD | |
United States, Texas | |
University of Texas Health Science Center | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Melissa Hernandez 210-567-0780 Hernandezma0@uthscsa.edu | |
Principal Investigator: Charles Bowden, MD |
Responsible Party: | Massachusetts General Hospital ( Andrew A. Nierenberg, MD ) |
Study ID Numbers: | N01 MH80001-01, DSIR AT |
Study First Received: | April 24, 2008 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00667745 |
Health Authority: | United States: Federal Government |
Lithium Symptoms Medication Changes |
Bipolar Disorder Benzocaine Olanzapine Risperidone Lithium Carbonate Affective Disorders, Psychotic Quetiapine |
Carbamazepine Mental Disorders Mood Disorders Psychotic Disorders Aripiprazole Ziprasidone Lithium |
Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Enzyme Inhibitors |
Antipsychotic Agents Antimanic Agents Pharmacologic Actions Pathologic Processes Therapeutic Uses Central Nervous System Agents Antidepressive Agents |