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Pharmacological Treatment of Children and Adolescents With Severe Mood Dysregulation

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT00825552
First received: January 16, 2009
Last updated: January 20, 2009
Last verified: January 2009
History of Changes
  Purpose

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


Condition Intervention
Severe Mood Dysregulation
 Drug: Risperidone

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Pharmacological Treatment of Children and Adolescents With Severe Mood Dysregulation. An Open Trial With Risperidone.

Resource links provided by NLM:

Drug Information available for: Risperidone
U.S. FDA Resources

Further study details as provided by Federal University of Rio Grande do Sul:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: January 2009
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Risperidone
    0,5-4 mg/day for 8 weeks (twice a day)
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.

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Bipolar disorder
  • IQ<70
  • Psychosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00825552

Locations
Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90000-010
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
  More Information

Additional Information:
Program of Bipolar Children and adolescents  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Luis Augusto Rohde, Federal University of Rio Grande do Sul, Brazil
ClinicalTrials.gov Identifier: NCT00825552     History of Changes
Other Study ID Numbers: 19091979
Study First Received: January 16, 2009
Last Updated: January 20, 2009
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of Rio Grande do Sul:
Risperidone
Severe mood dysregulation
bipolar
children

Additional relevant MeSH terms:
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
 Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 16, 2013