Long-Term Lithium Treatment for Aggressive Conduct Disorder - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00000385

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 III

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:

Drug Information available for: Lithium carbonate Lithium citrate

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

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:

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.

Contacts and Locations

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

National Institute of Mental Health (NIMH)

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, DSIR CT-M
Study First Received:	November 2, 1999
Last Updated:	April 15, 2008
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Aggressive conduct disorder
Adolescence
Child
Conduct Disorder
Female

Lithium
Male
Placebos
Conduct Disorder -- *drug therapy
Lithium -- *therapeutic use

Additional relevant MeSH terms:

Aggression
Conduct Disorder
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 February 12, 2012