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| ID | Type | Description | Link |
|---|---|---|---|
| R29MH057093 | U.S. NIH Grant/Contract | View source | |
| DSIR CT-M |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will examine the long-term effects of lithium used to treat children and adolescents with aggressive conduct disorder (severe aggression).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Lithium 600 mg to 2700 mg per day |
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| 2 | Placebo Comparator | Matching placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lithium | Drug | Lithium 600 mg to 2700 mg per day |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Overt Aggression Scale-Modified | Weekly in short term phase, Monthly in long-term phase | |
| Clinical Global Impressions-Improvement Item | Weekly in short term phase, Monthly in long-term phase |
| Measure | Description | Time Frame |
|---|---|---|
| Children's Psychiatric Rating Scale-Selected Items | Weekly in short term phase, Monthly in long-term phase | |
| IOWA | Weekly in short term phase, Monthly in long-term phase | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard P. Malone, MD | Drexel University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Drexel University College of Medicine at Friends Hospital | Philadelphia | Pennsylvania | 19124 | United States |
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| ID | Term |
|---|---|
| D019955 | Conduct Disorder |
| D000374 | Aggression |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D000096762 | Aberrant Motor Behavior in Dementia |
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| ID | Term |
|---|---|
| D008094 | Lithium |
| ID | Term |
|---|---|
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
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| Drug |
Matching placebo |
|
| DOTES |
| Weekly in short term phase, Monthly in long-term phase |
| TESS | Weekly in short term phase, Monthly in long-term phase |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012919 | Social Behavior |
| D008670 |
| Metals |