Long-Term Lithium Treatment for Aggressive Conduct Disorder

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Long-Term Lithium for Aggressive Conduct Disorder

Conditions
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Conduct Disorder, Aggression

Intervention / Treatment
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* Drug: Lithium
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females Ages between 9 and 17 years. Conduct disorder according to DSM-IV (As rated on the DICA-IV). The aggression criterion at screening Exclusion Criteria: Mental Retardation. Pervasive Developmental Disorder(s). Major Depressive Disorder or Dysthymic Disorder. Bipolar Disorder. Psychotic Disorder (including Schizophreniform Disorder and Schizophrenia). Major medical problem such as cardiac, renal, and thyroid diseases, or seizure disorder. History of psychoactive medication in the previous 2 weeks. Current Pregnancy in females. History of Substance Dependence in the past month. Prior to the proposed study, a history of lithium treatment with serum lithium levels of 0.4 mEq/L or higher for a cumulative period of greater than 10 days.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Lithium 600 mg to 2700 mg per day | Drug: Lithium<br>* Lithium 600 mg to 2700 mg per day<br>|
| Placebo Comparator: 2<br>Matching placebo | Drug: Placebo<br>* Matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| DOTES |  | Weekly in short term phase, Monthly in long-term phase | 
| TESS |  | Weekly in short term phase, Monthly in long-term phase | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aggressive conduct disorder, Adolescence, Child, Conduct Disorder, Female, Lithium, Male, Placebos, Conduct Disorder -- *drug therapy, Lithium -- *therapeutic use