Philadelphia, Pennsylvania 19124

  • Aggression

Purpose:

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


Study summary:

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.


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.


Study is Available At:


Original ID:

R29 MH57093


NCT ID:

NCT00000385


Secondary ID:

R29MH057093


Study Acronym:


Brief Title:

Long-Term Lithium Treatment for Aggressive Conduct Disorder


Official Title:

Long-Term Lithium for Aggressive Conduct Disorder


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

9 Years


Maximum Age:

17 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Drexel University


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

59


Enrollment Type:

Actual


Overall Contact Information

Official Name:Richard P. Malone, MD
Principal Investigator
Drexel University College of Medicine

Study Dates

Start Date:September 1997
Completion Date:June 2005
Completion Type:Actual
Primary Completion Date:December 2003
Primary Completion Type:Actual
Verification Date:November 2013
Last Changed Date:November 25, 2013
First Received Date:November 2, 1999

Study Outcomes

Outcome Type:Secondary Outcome
Measure:TESS
Time Frame:Weekly in short term phase, Monthly in long-term phase
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:DOTES
Time Frame:Weekly in short term phase, Monthly in long-term phase
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:IOWA
Time Frame:Weekly in short term phase, Monthly in long-term phase
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Children's Psychiatric Rating Scale-Selected Items
Time Frame:Weekly in short term phase, Monthly in long-term phase
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Clinical Global Impressions-Improvement Item
Time Frame:Weekly in short term phase, Monthly in long-term phase
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Overt Aggression Scale-Modified
Time Frame:Weekly in short term phase, Monthly in long-term phase
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Placebo
Description:Matching placebo
Arm Name:2
Intervention Type:Drug
Name:Lithium
Description:Lithium 600 mg to 2700 mg per day
Arm Name:1

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:2
Description:Matching placebo
Study Arm Type:Experimental
Arm Name:1
Description:Lithium 600 mg to 2700 mg per day

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Drexel University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Mental Health (NIMH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

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