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Pharmacological Treatment of Children and Adolescents With Severe Mood Dysregulation

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ClinicalTrials.gov Identifier: NCT00825552
Recruitment Status : Unknown
Verified January 2009 by Federal University of Rio Grande do Sul.
Recruitment status was:  Enrolling by invitation
First Posted : January 21, 2009
Last Update Posted : January 21, 2009
Sponsor:
Information provided by:
Federal University of Rio Grande do Sul

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 : January 2009
Estimated Primary Completion Date : January 2010
Estimated Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Risperidone


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


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 [ Time Frame: 11/2010 ]


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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Bipolar disorder
  • IQ<70
  • Psychosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
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
First Posted: January 21, 2009    Key Record Dates
Last Update Posted: January 21, 2009
Last Verified: January 2009

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
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents