Pharmacological Treatment of Children and Adolescents With Severe Mood Dysregulation

Severe Mood Dysregulation Clinical Trial

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

Status Enrolling by invitation

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Severe Mood Dysregulation

• NCT number: NCT00825552
• Study type: Interventional
• Source: Federal University of Rio Grande do Sul
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 2009
• Completion date: November 2010