Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2025-12-24 @ 9:37 PM
NCT ID:
NCT00217932
Eligibility Criteria:
Inclusion Criteria:
* Meets criteria for Explosive Mood Disorder (EMD)
* Explosive temper as evidenced by four or more outbursts of rage, property destruction, or fighting per month
* Mood liability as evidenced by multiple, daily, distinct shifts from normal to irritable mood with withdrawn or boisterous behavior, occurring without a clear precipitant
* History of an EMD for one year without treatment
* EMD symptoms resulting in impairment in two or more of the following areas: school, the law, family, substance use, peers, or work
* EMD symptoms do not occur only during substance toxicity or withdrawal
* EMD symptoms are not confined to a single setting or context
* Parent and child willing to consent to study
* Inadequate response to an adequate trial (8 weeks) of psychotherapy and/or family therapy
Exclusion Criteria:
* Meets criteria for pervasive developmental disorder or childhood schizophrenia
* Seizure or other neurologic disturbance
* Pregnant
* Moderate to severe mental retardation
* Physical exam or laboratory results with significant abnormalities
* Positive Hepatitis screen test
* Liver dysfunction
* Active suicidal or homicidal ideation
* History of suicide attempts
* History of barbiturate use
* Unequivocal manic or hypomanic episode
* Meets criteria for attention deficit hyperactivity disorder (ADHD) and has not failed a trial of psychostimulants for ADHD
* Meets criteria for major depression in prepuberty
* If female, unwilling to use an effective method of contraception for the duration of the study
* Mitochondrial disease or family history of mitochondrial disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
11 Years
Study:
NCT00217932
Study Brief:
Protocol Section:
NCT00217932