Long-Term Lithium Treatment for Aggressive Conduct Disorder

Sponsor

Drexel University (Other)

Overall Status

Completed

CT.gov ID

NCT00000385

Collaborator

National Institute of Mental Health (NIMH) (NIH)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Conduct Disorder Aggression	Drug: Lithium Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

59 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Long-Term Lithium for Aggressive Conduct Disorder

Study Start Date :

Sep 1, 1997

Actual Primary Completion Date :

Dec 1, 2003

Actual Study Completion Date :

Jun 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Lithium 600 mg to 2700 mg per day	Drug: Lithium Lithium 600 mg to 2700 mg per day
Placebo Comparator: 2 Matching placebo	Drug: Placebo Matching placebo

Arm

Intervention/Treatment

Experimental: 1

Lithium 600 mg to 2700 mg per day

Drug: Lithium

Lithium 600 mg to 2700 mg per day

Placebo Comparator: 2

Matching placebo

Drug: Placebo

Matching placebo

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.