NCT00825552

Pharmacological Treatment of Children and Adolescents With Severe Mood Dysregulation

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Federal University of Rio Grande do Sul · Academic / Other
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Mood Dysregulation

Interventions

Type	Name	Description
DRUG	Risperidone	0,5-4 mg/day for 8 weeks (twice a day)

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-01-01
• Completion: 2010-11-01
• First posted: 2009-01-21
• Last updated: 2009-01-21

Locations

2 sites across 1 country: Brazil