Clinical Trial: Long-Term Lithium Treatment for Aggressive Conduct Disorder

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Long-Term Lithium for Aggressive Conduct Disorder

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

Detailed Summary:

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.


Sponsor: Drexel University

Current Primary Outcome:

  • Overt Aggression Scale-Modified [ Time Frame: Weekly in short term phase, Monthly in long-term phase ]
  • Clinical Global Impressions-Improvement Item [ Time Frame: Weekly in short term phase, Monthly in long-term phase ]


Original Primary Outcome:

Current Secondary Outcome:

  • Children's Psychiatric Rating Scale-Selected Items [ Time Frame: Weekly in short term phase, Monthly in long-term phase ]
  • IOWA [ Time Frame: Weekly in short term phase, Monthly in long-term phase ]
  • DOTES [ Time Frame: Weekly in short term phase, Monthly in long-term phase ]
  • TESS [ Time Frame: Weekly in short term phase, Monthly in long-term phase ]


Original Secondary Outcome:

Information By: Drexel University

Dates:
Date Received: November 2, 1999
Date Started: September 1997
Date Completion:
Last Updated: November 25, 2013
Last Verified: November 2013