Pharmacological Treatment of Children and Adolescents With Severe Mood Dysregulation

Federal University of Rio Grande do Sul20 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Severe Mood Dysregulation

Interventions

RisperidoneDRUG

0,5-4 mg/day for 8 weeks (twice a day)

Eligibility

Sex: ALLMin age: 7 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnose of Severe Mood Dysregulation * 7-17 years * IQ \> 70 Exclusion Criteria: * Bipolar disorder * IQ\<70 * Psychosis

Locations (2)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

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

Data from ClinicalTrials.gov

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