Severe Mood Dysregulation Clinical Trial
Official title:
Pharmacological Treatment of Children and Adolescents With Severe Mood Dysregulation. An Open Trial With Risperidone.
Verified date | January 2009 |
Source | Federal University of Rio Grande do Sul |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ethics Committee |
Study type | Interventional |
The purpose of this study is to investigate whether Risperidone is effective in children and adolescents with severe mood dysregulation.
Status | Enrolling by invitation |
Enrollment | 20 |
Est. completion date | November 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 7 Years to 17 Years |
Eligibility |
Inclusion Criteria: - Diagnose of Severe Mood Dysregulation - 7-17 years - IQ > 70 Exclusion Criteria: - Bipolar disorder - IQ<70 - Psychosis |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital de Clinicas de Porto Alegre | Porto Alegre | Rio Grande do Sul |
Brazil | Hospital de Clinicas de Porto Alegre | Porto Alegre | RS |
Lead Sponsor | Collaborator |
---|---|
Federal University of Rio Grande do Sul |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | We use as the primary outcome the subscale of irritability of the Aberrant Checklist Behavior which measures the intensity of irritability, temper tantruns and hyperarousal symptoms | 11/2010 | Yes |
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