Long-Term Lithium Treatment for Aggressive Conduct Disorder

Aggression Clinical Trial

Official title:

Long-Term Lithium for Aggressive Conduct Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000385
• Other study ID #: R29MH057093
• Secondary ID: R29MH057093DSIR
• Status: Completed
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: November 25, 2013
• Start date: September 1997
• Est. completion date: June 2005

Study information

• Verified date: November 2013
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: June 2005
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 17 Years

Eligibility

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

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.

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

Intervention

Drug:
• Lithium
Lithium 600 mg to 2700 mg per day
• Placebo
Matching placebo

Locations

Country	Name	City	State
United States	Drexel University College of Medicine at Friends Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Drexel University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overt Aggression Scale-Modified		Weekly in short term phase, Monthly in long-term phase	No
Primary	Clinical Global Impressions-Improvement Item		Weekly in short term phase, Monthly in long-term phase	No
Secondary	Children's Psychiatric Rating Scale-Selected Items		Weekly in short term phase, Monthly in long-term phase	No
Secondary	IOWA		Weekly in short term phase, Monthly in long-term phase	No
Secondary	DOTES		Weekly in short term phase, Monthly in long-term phase	Yes
Secondary	TESS		Weekly in short term phase, Monthly in long-term phase	Yes