Pharmacological Treatment of Children and Adolescents With Severe Mood Dysregulation

Federal University of Rio Grande do Sul

Status: Unknown

Conditions: Severe Mood Dysregulation

Treatments: Drug: Risperidone

Study type: Interventional

Funder types: Other

Identifiers

NCT00825552

19091979

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnose of Severe Mood Dysregulation
• 7-17 years
• IQ > 70

Exclusion criteria

• Bipolar disorder
• IQ<70
• Psychosis

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind