Long-Term Lithium Treatment for Aggressive Conduct Disorder

Phase 3

Completed

• Conditions: Aggression; Conduct Disorder
• Interventions: Drug: Placebo; Drug: Lithium

• Registration Number: NCT00000385
• Lead Sponsor: Drexel University

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 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 Timeline

• Study Start: 1997-09
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 1999-11-02
• Study First Posted: 1999-11-03
• Primary Completion: 2003-12
• Study Completion: 2005-06
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-25
• Last Update Posted: 2013-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

1. Males and females
2. Ages between 9 and 17 years.
3. Conduct disorder according to DSM-IV (As rated on the DICA-IV).
4. The aggression criterion at screening

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Exclusion Criteria

1. Mental Retardation.
2. Pervasive Developmental Disorder(s).
3. Major Depressive Disorder or Dysthymic Disorder.
4. Bipolar Disorder.
5. Psychotic Disorder (including Schizophreniform Disorder and Schizophrenia).
6. Major medical problem such as cardiac, renal, and thyroid diseases, or seizure disorder.
7. History of psychoactive medication in the previous 2 weeks.
8. Current Pregnancy in females.
9. History of Substance Dependence in the past month.
10. 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Matching placebo
1	Lithium	Lithium 600 mg to 2700 mg per day

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Drexel University College of Medicine at Friends Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States