We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharmacological Treatment of Children and Adolescents With Severe Mood Dysregulation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2009 by Federal University of Rio Grande do Sul.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00825552
First Posted: January 21, 2009
Last Update Posted: January 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Federal University of Rio Grande do Sul
  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: 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.

Resource links provided by NLM:


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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

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 Submitted: January 16, 2009
First Posted: January 21, 2009
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