Long-Term Lithium Treatment for Aggressive Conduct Disorder

Aggression Clinical Trial

Official title: Long-Term Lithium for Aggressive Conduct Disorder

Status Completed

Clinical Trial Summary

This study will examine the long-term effects of lithium used to treat children and adolescents with aggressive conduct disorder (severe aggression).

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aggression
• Conduct Disorder
• Disease

• NCT number: NCT00000385
• Study type: Interventional
• Source: Drexel University
• Status: Completed
• Phase: Phase 3
• Start date: September 1997
• Completion date: June 2005