Long-Term Lithium Treatment for Aggressive Conduct Disorder

Long-Term Lithium for Aggressive Conduct Disorder

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

Study Overview

• Status: Completed
• Conditions: Aggression; Conduct Disorder
• Intervention / Treatment: Drug: Placebo; Drug: Lithium

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 Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19124
      • Drexel University College of Medicine at Friends Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Drexel University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Richard P. Malone, MD, Drexel University College of Medicine

Study record dates

Study Major Dates

• Study Start: September 1, 1997
• Primary Completion (Actual): December 1, 2003
• Study Completion (Actual): June 1, 2005

Study Registration Dates

• First Submitted: November 2, 1999
• First Submitted That Met QC Criteria: November 2, 1999
• First Posted (Estimate): November 3, 1999

Study Record Updates

• Last Update Posted (Estimate): November 26, 2013
• Last Update Submitted That Met QC Criteria: November 25, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Child; Placebos; Female; Male; Adolescence; Lithium; Conduct Disorder; Lithium -- *therapeutic use; Aggressive conduct disorder; Conduct Disorder -- *drug therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Aggression; Disease; Conduct Disorder; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Antimanic Agents; Lithium Carbonate
• Other Study ID Numbers: R29MH057093 (U.S. NIH Grant/Contract); DSIR CT-M