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Clinical Trials/NCT00825552
NCT00825552
Unknown
Not Applicable

Pharmacological Treatment of Children and Adolescents With Severe Mood Dysregulation. An Open Trial With Risperidone.

Federal University of Rio Grande do Sul1 site in 1 country20 target enrollmentJanuary 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Severe Mood Dysregulation
Sponsor
Federal University of Rio Grande do Sul
Enrollment
20
Locations
1
Primary Endpoint
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
Last Updated
17 years ago

Overview

Brief Summary

The purpose of this study is to investigate whether Risperidone is effective in children and adolescents with severe mood dysregulation.

Detailed Description

Severe Mood Dysregulation(SMD) is a new construct in children and adolescents characterized by persistent and non episodic irritability, hyperarousal and emotional reactivity. This is an open label trial using Risperidone in children and adolescents( 7-17 years old) diagnosed with SMD. We hypothesized that Risperidone would improve externalizing symptoms as well as depressive and/or maniac symptomatology. We also consider the effect of the pharmacological intervention in the co-morbid disorders especially ADHD.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
November 2010
Last Updated
17 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Federal University of Rio Grande do Sul

Eligibility Criteria

Inclusion Criteria

  • Diagnose of Severe Mood Dysregulation
  • 7-17 years

Exclusion Criteria

  • Bipolar disorder
  • Psychosis

Outcomes

Primary Outcomes

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

Time Frame: 11/2010

Study Sites (1)

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