NCT00218114

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2000

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2000

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

August 10, 2017

Status Verified

August 1, 2017

Enrollment Period

5.1 years

First QC Date

September 16, 2005

Last Update Submit

August 8, 2017

Conditions

Attention Deficit and Disruptive Behavior DisordersMarijuana Abuse

Keywords

ADHD, disruptive behavior disorder, marijuana abuse

Outcome Measures

Primary Outcomes (1)

  • Symptoms of disruptive behavior disorder

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

    6 weeks

Study Arms (2)

1

EXPERIMENTAL

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.

Drug: Divalproex Sodium

2

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Divalproex SodiumDRUG

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.

Also known as: Depakote
1
PlaceboDRUG

Participants will be on matching placebo.

2

Eligibility Criteria

Age12 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Attention Deficit and Disruptive Behavior DisordersMarijuana AbuseAttention Deficit Disorder with Hyperactivity

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersSubstance-Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Stephen Donovan, MD

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

February 1, 2000

Primary Completion

February 18, 2005

Study Completion

February 18, 2005

Last Updated

August 10, 2017

Record last verified: 2017-08

Locations

US(1)