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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: | NCT00183443 |
This study will determine the effectiveness of three different drug therapies in treating the symptoms of mania.
Condition | Intervention | Phase |
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Bipolar Disorder Schizophrenia |
Drug: Divalproex-extended release (DVP-ER) Drug: Lithium Drug: Quetiapine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Divalproex Extended Release and Placebo, Lithium, or Quetiapine for Mania |
Estimated Enrollment: | 105 |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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DVP + placebo: Placebo Comparator
Participants will receive divalproex ER at a therapeutic dose, plus placebo
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Drug: Divalproex-extended release (DVP-ER)
Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
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DVP + Quetiapine: Active Comparator
Participants will receive divalproex ER at a therapeutic dose, plus quetiapine up to 800 mg
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Drug: Divalproex-extended release (DVP-ER)
Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
Drug: Quetiapine
Quetiapine will be dosed to efficacy, provided in 50 mg, 100 mg, 200 mg, or 300 mg pills.
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DVP + Lithium: Active Comparator
Participants will receive divalproex ER at a therapeutic dose, plus lithium at a therapeutic blood level
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Drug: Divalproex-extended release (DVP-ER)
Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.
Drug: Lithium
Extended release lithium will be provided in 300 mg capsules. Participants will be dosed to a therapeutic blood level of lithium from 0.8 to 1.2 mcg/L.
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Mania is a serious condition characterized by extreme excitement, mental and physical hyperactivity, insomnia, and disconnected thoughts. Symptoms of mania are common in patients with schizophrenia or bipolar disorder. When associated with these conditions, mania reaches psychotic proportions and often includes hallucinations, paranoia, and feelings of omnipotence. Such symptoms may put individuals with mania and those around them at risk for physical harm. Drug therapies that can safely and effectively treat symptoms of mania are needed. This study will compare three drug combinations in their ability to treat symptoms of mania in people with schizophrenia or bipolar I disorder.
This study will last 26 weeks and will comprise two parts. In Part 1, participants will be randomly assigned to receive one of three treatments:
divalproex-extended release (DV-ER) and lithium, DV-ER and quetiapine, or DV-ER and placebo. Participants will receive their intervention for 12 weeks.
Participants will have weekly study visits for the first 4 weeks of Phase 1; biweekly study visits will occur for the following 8 weeks. After Phase 1, participants who have not responded to their drug regimen will complete their participation in the study.
Participants whose symptoms of mania have decreased will be enrolled in Phase 2. During this 14-week continuation phase, participants will continue the drug regimen they began in Phase 1. Participants will have biweekly study visits in Phase 2. During each study visit in Phases 1 and 2, participants will be interviewed about their mania symptoms. Mania, depression, quality of life, and overall functioning scales will assess participants at study entry, at the end of Phase 1, and at the end of Phase 2. Participants over 50 years of age will have an electrocardiogram (EKG) at study entry to determine cardiac function.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Grace Fischer | 650-493-5000 ext 67570 | eileen.fischer@va.gov |
United States, California | |
Stanford School of Medicine and VA Palo Alto Health Care System | Recruiting |
Palo Alto, California, United States, 94304 | |
Contact: Grace Fischer 650-493-5000 ext 67570 eileen.fischer@va.gov | |
Principal Investigator: Trisha Suppes, MD, PhD |
Principal Investigator: | Trisha Suppes, MD, PhD | Stanford School of Medicine and VA Palo Alto Health Care System |
Responsible Party: | Stanford Medical School and VA Palo Alto Health Care System ( Trisha Suppes, MD, PhD ) |
Study ID Numbers: | R01 MH069801, DSIR 83-ATSO |
Study First Received: | September 13, 2005 |
Last Updated: | April 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00183443 History of Changes |
Health Authority: | United States: Federal Government |
Mania Manic-depressive Psychotic disorder |
Neurotransmitter Agents Tranquilizing Agents Bipolar Disorder Psychotropic Drugs Central Nervous System Depressants Lithium Carbonate Antipsychotic Agents Antimanic Agents Valproic Acid |
Schizophrenia Affective Disorders, Psychotic Quetiapine Mental Disorders Mood Disorders Psychotic Disorders Anticonvulsants Schizophrenia and Disorders with Psychotic Features Lithium |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Bipolar Disorder Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Enzyme Inhibitors Antipsychotic Agents Antimanic Agents Valproic Acid Pharmacologic Actions |
Schizophrenia Affective Disorders, Psychotic Quetiapine Mental Disorders Therapeutic Uses Mood Disorders GABA Agents Central Nervous System Agents Anticonvulsants Schizophrenia and Disorders with Psychotic Features Lithium |