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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

January 16, 2009
January 21, 2009
January 21, 2009
January 2009
January 2010   (Final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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.
The purpose of this study is to investigate whether Risperidone is effective in children and adolescents with severe mood dysregulation.

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.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Severe Mood Dysregulation
Drug: Risperidone
0,5-4 mg/day for 8 weeks (twice a day)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
20
Same as current
November 2010
January 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Bipolar disorder
  • IQ<70
  • Psychosis
Sexes Eligible for Study: All
7 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT00825552
19091979
Yes
Not Provided
Not Provided
Luis Augusto Rohde, Federal University of Rio Grande do Sul, Brazil
Federal University of Rio Grande do Sul
Not Provided
Study Chair: Rohde A Luis, Phd Federal University of Rio Grande do Sul
Federal University of Rio Grande do Sul
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP