Pharmacological Treatment of Children and Adolescents With Severe Mood Dysregulation

• Sponsor: Federal University of Rio Grande do Sul (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00825552
• Collaborator: (none)
• Enrollment: 20
• Locations: 2
• Duration (Months): 22
• Patients Per Site: 10
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Severe Mood Dysregulation	Drug: Risperidone	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Pharmacological Treatment of Children and Adolescents With Severe Mood Dysregulation. An Open Trial With Risperidone.
• Study Start Date: Jan 1, 2009
• Anticipated Primary Completion Date: Jan 1, 2010
• Anticipated Study Completion Date: Nov 1, 2010

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnose of Severe Mood Dysregulation

• 7-17 years

• IQ > 70

Exclusion Criteria:

• Bipolar disorder

• IQ<70

• Psychosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande do Sul	Brazil	90000-010
2	Hospital de Clinicas de Porto Alegre	Porto Alegre	RS	Brazil	90350-903

Sponsors and Collaborators

• Federal University of Rio Grande do Sul

Investigators

• Study Chair: Rohde A Luis, Phd, Federal University of Rio Grande do Sul

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Program of Bipolar Children and adolescents

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00825552
• Other Study ID Numbers: 19091979
• First Posted: Jan 21, 2009
• Last Update Posted: Jan 21, 2009
• Last Verified: Jan 1, 2009

• Keywords provided by , ,: Risperidone; Severe mood dysregulation; bipolar; children
• Additional relevant MeSH terms: Risperidone

Study Results

No Results Posted as of Jan 21, 2009