- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00218114
Divalproex Sodium (Depakote) for Explosive Tempers in Adolescents and Adults
Parallel Groups Study of Divalproex Sodium (Depakote) for Irritable, Explosive Adults & Adolescents
Study Overview
Status
Intervention / Treatment
Detailed Description
Disruptive behavior disorders among children and adolescents are readily diagnosed; however, few individuals with such disorders receive drug treatment. Depakote is a mood stabilizing medication that may be beneficial in treating individuals with disruptive behavior disorders. The purpose of this study is to examine the effectiveness of Depakote in reducing temper outbursts and improving mood in individuals with disruptive behavior disorders. In addition, this study will determine the safety and effectiveness of Depakote in treating individuals with substance disorders who also have disruptive behavior disorders.
This study will last 6 weeks. Participants will be randomly assigned to receive treatment with Depakote or placebo. Medication will be given in a single evening dose if tolerated; otherwise, medication will be given twice per day. Participants will be assigned to a fixed-flexible dosing schedule and dosages will increase based on weight. All participants will attend weekly psychotherapy and family counseling sessions throughout the study. Participants who are substance abusers will also receive substance abuse counseling. Weekly study visits will include a physical exam, blood collection, and drug tests. Teachers and guidance counselors will be contacted to assess the participant's behavior from week to week. Some participants will complete a follow-up study, in which they will take part in phone interviews.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10032
- New York State Psychiatric Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Meets DSM-IV criteria for a disruptive behavior disorder (e.g., oppositional/defiant disorder, conduct disorder)
- Explosive temper, defined as four or more outbursts of rage, property destruction, or fighting per month
- Mood liability, defined as having multiple, daily, distinct shifts from normal to irritable mood with withdrawn or boisterous behavior
- Chronic symptoms, defined of at least 1 year duration when not receiving treatment
- Impairment from the above symptoms in two or more areas, including school, the law, family, substance use, peers, or work (as manifested by a GAF score of 55 or less)
- Symptoms not limited to a particular place or to particular intimate relationships
- General good health
- Custodial parent or guardian gives informed consent
Exclusion Criteria:
- History of non drug-induced psychosis
- Seizure or other neurologic disturbance
- Pregnant
- Moderate to severe mental retardation
- Sexually active females who refuse to use an adequate method of contraception for the duration of the study
- Significant medical problems
- Current suicidal or homicidal ideation
- Uses barbiturates
- Refusal to permit weekly contact with school officials
- Bipolar I or II disorder
- Major depressive disorder
- First degree relative with bipolar I or II disorder
- Attention deficit/hyperactivity disorder
- Post traumatic stress disorder
- Clinical evidence of hyperandrogenism in a female
- Liver disease
- Thrombocytopenia
- Pancreatic disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
Divalproex sodium (Depakote).
This is a parallel groups design lasting a total of six weeks.
Participants will be on a fixed-flexible dosing schedule.
The dose of depakote will be raised to 750mgs or 1000mgs, depending on weight, in two weeks to achieve blood levels between 50-130 micrograms per milliliter.
If a patient does not achieve this blood level on 750mgs or 1000 mgs, the dose may be raised during the second week.
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Participants are titrated over 2 weeks, as tolerated to 10 mgs / pound, and blood levels are checked to determine that the blood level is between 50-110 micrograms / ml.
Other Names:
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PLACEBO_COMPARATOR: 2
This is a parallel groups design lasting a total of six weeks.
Participants will be on matching placebo for 250 mgs divalproex sodium (Depakote).
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Participants will be on matching placebo.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptoms of disruptive behavior disorder
Time Frame: 6 weeks
|
Measure symptoms of disruptive behavior disorder with the modified overt aggression scale throughout the study and at Week 6
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6 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Stephen Donovan, MD, New York State Psychiatric Institute
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Chemically-Induced Disorders
- Substance-Related Disorders
- Neurodevelopmental Disorders
- Problem Behavior
- Mental Disorders
- Marijuana Abuse
- Attention Deficit and Disruptive Behavior Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Enzyme Inhibitors
- Tranquilizing Agents
- Psychotropic Drugs
- GABA Agents
- Anticonvulsants
- Antimanic Agents
- Valproic Acid
Other Study ID Numbers
- #4767R
- R01DA012234 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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