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Divalproex Sodium (Depakote) for Explosive Tempers in Adolescents and Adults

Primary Purpose

Attention Deficit and Disruptive Behavior Disorders, Marijuana Abuse

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Divalproex Sodium
Placebo
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit and Disruptive Behavior Disorders focused on measuring ADHD, disruptive behavior disorder, marijuana abuse

Eligibility Criteria

12 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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per month Mood liability, defined as having multiple, daily, distinct shifts from normal to irritable mood with withdrawn or boisterous behavior Chronic symptoms, defined of at least 1 year duration when not receiving treatment Impairment from the above symptoms in two or more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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

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.

This is a parallel groups design lasting a total of six weeks. Participants will be on matching placebo for 250 mgs divalproex sodium (Depakote).

Outcomes

Primary Outcome Measures

Symptoms of disruptive behavior disorder
Measure symptoms of disruptive behavior disorder with the modified overt aggression scale throughout the study and at Week 6

Secondary Outcome Measures

Full Information

First Posted
September 16, 2005
Last Updated
August 8, 2017
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00218114
Brief Title
Divalproex Sodium (Depakote) for Explosive Tempers in Adolescents and Adults
Official Title
Parallel Groups Study of Divalproex Sodium (Depakote) for Irritable, Explosive Adults & Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
February 2000 (Actual)
Primary Completion Date
February 18, 2005 (Actual)
Study Completion Date
February 18, 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the effectiveness of divalproex sodium (Depakote) versus placebo in treating disruptive behavior disorder and explosive tempers in adolescents and adults.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit and Disruptive Behavior Disorders, Marijuana Abuse
Keywords
ADHD, disruptive behavior disorder, marijuana abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
This is a parallel groups design lasting a total of six weeks. Participants will be on matching placebo for 250 mgs divalproex sodium (Depakote).
Intervention Type
Drug
Intervention Name(s)
Divalproex Sodium
Other Intervention Name(s)
Depakote
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will be on matching placebo.
Primary Outcome Measure Information:
Title
Symptoms of disruptive behavior disorder
Description
Measure symptoms of disruptive behavior disorder with the modified overt aggression scale throughout the study and at Week 6
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Donovan, MD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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Divalproex Sodium (Depakote) for Explosive Tempers in Adolescents and Adults

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