search
Back to results

Long-Term Lithium Treatment for Aggressive Conduct Disorder

Primary Purpose

Conduct Disorder, Aggression

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lithium
Placebo
Sponsored by
Drexel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Conduct Disorder focused on measuring Aggressive conduct disorder, Adolescence, Child, Conduct Disorder, Female, Lithium, Male, Placebos, Conduct Disorder -- *drug therapy, Lithium -- *therapeutic use

Eligibility Criteria

9 Years - 17 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Drexel University College of Medicine at Friends Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Lithium 600 mg to 2700 mg per day

Matching placebo

Outcomes

Primary Outcome Measures

Overt Aggression Scale-Modified
Clinical Global Impressions-Improvement Item

Secondary Outcome Measures

Children's Psychiatric Rating Scale-Selected Items
IOWA
DOTES
TESS

Full Information

First Posted
November 2, 1999
Last Updated
November 25, 2013
Sponsor
Drexel University
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT00000385
Brief Title
Long-Term Lithium Treatment for Aggressive Conduct Disorder
Official Title
Long-Term Lithium for Aggressive Conduct Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
September 1997 (undefined)
Primary Completion Date
December 2003 (Actual)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Drexel University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conduct Disorder, Aggression
Keywords
Aggressive conduct disorder, Adolescence, Child, Conduct Disorder, Female, Lithium, Male, Placebos, Conduct Disorder -- *drug therapy, Lithium -- *therapeutic use

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Lithium 600 mg to 2700 mg per day
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Matching placebo
Intervention Type
Drug
Intervention Name(s)
Lithium
Intervention Description
Lithium 600 mg to 2700 mg per day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
Overt Aggression Scale-Modified
Time Frame
Weekly in short term phase, Monthly in long-term phase
Title
Clinical Global Impressions-Improvement Item
Time Frame
Weekly in short term phase, Monthly in long-term phase
Secondary Outcome Measure Information:
Title
Children's Psychiatric Rating Scale-Selected Items
Time Frame
Weekly in short term phase, Monthly in long-term phase
Title
IOWA
Time Frame
Weekly in short term phase, Monthly in long-term phase
Title
DOTES
Time Frame
Weekly in short term phase, Monthly in long-term phase
Title
TESS
Time Frame
Weekly in short term phase, Monthly in long-term phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard P. Malone, MD
Organizational Affiliation
Drexel University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drexel University College of Medicine at Friends Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19124
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Long-Term Lithium Treatment for Aggressive Conduct Disorder

We'll reach out to this number within 24 hrs