Marijuana Abuse Clinical Trial
Official title:
Parallel Groups Study of Divalproex Sodium (Depakote) for Irritable, Explosive Adults & Adolescents
Verified date | August 2017 |
Source | New York State Psychiatric Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | February 18, 2005 |
Est. primary completion date | February 18, 2005 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 55 Years |
Eligibility |
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per month - Mood liability, defined as having multiple, daily, distinct shifts from normal to irritable mood with withdrawn or boisterous behavior - Chronic symptoms, defined of at least 1 year duration when not receiving treatment - Impairment from the above symptoms in two or more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 |
Country | Name | City | State |
---|---|---|---|
United States | New York State Psychiatric Institute | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York State Psychiatric Institute | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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