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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00825552
• Other study ID #: 19091979
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 16, 2009
• Last updated: January 20, 2009
• Start date: January 2009
• Est. completion date: November 2010

Study information

• 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

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

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

Intervention

Drug:
• Risperidone
0,5-4 mg/day for 8 weeks (twice a day)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

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

External Links

•   Program of Bipolar Children and adolescents