Long-Term Lithium Treatment for Aggressive Conduct Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Drexel University
ClinicalTrials.gov Identifier:
NCT00000385
First received: November 2, 1999
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Conduct Disorder
Aggression
Drug: Lithium
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long-Term Lithium for Aggressive Conduct Disorder

Resource links provided by NLM:


Further study details as provided by Drexel University:

Primary Outcome Measures:
  • Overt Aggression Scale-Modified [ Time Frame: Weekly in short term phase, Monthly in long-term phase ] [ Designated as safety issue: No ]
  • Clinical Global Impressions-Improvement Item [ Time Frame: Weekly in short term phase, Monthly in long-term phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Children's Psychiatric Rating Scale-Selected Items [ Time Frame: Weekly in short term phase, Monthly in long-term phase ] [ Designated as safety issue: No ]
  • IOWA [ Time Frame: Weekly in short term phase, Monthly in long-term phase ] [ Designated as safety issue: No ]
  • DOTES [ Time Frame: Weekly in short term phase, Monthly in long-term phase ] [ Designated as safety issue: Yes ]
  • TESS [ Time Frame: Weekly in short term phase, Monthly in long-term phase ] [ Designated as safety issue: Yes ]

Enrollment: 59
Study Start Date: September 1997
Study Completion Date: June 2005
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   9 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000385

Locations
United States, Pennsylvania
Drexel University College of Medicine at Friends Hospital
Philadelphia, Pennsylvania, United States, 19124
Sponsors and Collaborators
Drexel University
Investigators
Principal Investigator: Richard P. Malone, MD Drexel University College of Medicine
  More Information

No publications provided

Responsible Party: Richard P. Malone, MD, Drexel University College of Medicine
ClinicalTrials.gov Identifier: NCT00000385     History of Changes
Other Study ID Numbers: R29 MH57093, R29MH057093, DSIR CT-M
Study First Received: November 2, 1999
Last Updated: November 25, 2013
Health Authority: United States: Federal Government

Keywords provided by Drexel University:
Aggressive conduct disorder
Adolescence
Child
Conduct Disorder
Female
Lithium
Male
Placebos
Conduct Disorder -- *drug therapy
Lithium -- *therapeutic use

Additional relevant MeSH terms:
Disease
Aggression
Conduct Disorder
Pathologic Processes
Behavioral Symptoms
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Lithium
Lithium Carbonate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antimanic Agents
Antidepressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014