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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: | NCT00000385 |
This study will examine the long-term effects of lithium used to treat children and adolescents with aggressive conduct disorder (severe aggression).
Condition | Intervention | Phase |
---|---|---|
Conduct Disorder Aggression |
Drug: Lithium Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Long-Term Lithium for Aggressive Conduct Disorder |
Enrollment: | 59 |
Study Start Date: | September 1997 |
Study Completion Date: | June 2005 |
Primary Completion Date: | December 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Lithium 600 mg to 2700 mg per day
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Drug: Lithium
Lithium 600 mg to 2700 mg per day
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2: Placebo Comparator
Matching placebo
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Drug: Placebo
Matching placebo
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Psychotherapeutic agents are often administered without sufficient testing to children and adolescents, often on a long-term basis, to reduce aggression. Many pressures, including managed care, will increase the utilization of pharmacotherapy in the outpatient setting to treat serious problems. Lithium is the most promising agent for the treatment of aggression in children and adolescents. However, it has not been shown that lithium is an effective treatment for these patients in the outpatient (non-hospital) setting, or on a long-term basis. The purpose of this study is to examine the long-term effects of lithium used to treat children and adolescents with aggressive conduct disorder (severe aggression).
The proposed study is a two-phased clinical trial of lithium for the treatment of aggression in conduct disorder. Both phases are double-blind and placebo-controlled with randomization and employ a parallel groups design. Phase 1 contains a short-term 8-week controlled trial, with twice as many subjects randomized to lithium as placebo, increasing the pool of potential lithium responders to continue to Phase 2. In Phase 2, lithium responders from Phase 1 enter a 6-month long-term controlled trial. Every attempt is made to define responders to lithium.
Ages Eligible for Study: | 9 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Drexel University College of Medicine at Friends Hospital | |
Philadelphia, Pennsylvania, United States, 19124 |
Principal Investigator: | Richard P. Malone, MD | Drexel University College of Medicine |
Responsible Party: | Drexel University College of Medicine ( Richard P. Malone, MD ) |
Study ID Numbers: | R29 MH57093, DSIR CT-M |
Study First Received: | November 2, 1999 |
Last Updated: | April 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00000385 |
Health Authority: | United States: Federal Government |
Aggressive conduct disorder Adolescence Child Conduct Disorder Female |
Lithium Male Placebos Conduct Disorder -- *drug therapy Lithium -- *therapeutic use |
Conduct Disorder Mental Disorders Mental Disorders Diagnosed in Childhood Lithium Carbonate |
Attention Deficit and Disruptive Behavior Disorders Aggression Lithium Behavioral Symptoms |
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 |