Pharmacological Treatment of Children and Adolescents With Severe Mood Dysregulation

NCT ID: NCT00825552

Last Updated: 2009-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Severe Mood Dysregulation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Interventions

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Risperidone

0,5-4 mg/day for 8 weeks (twice a day)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Bipolar disorder
* IQ\<70
* Psychosis
Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Rio Grande do Sul

OTHER

Sponsor Role lead

Responsible Party

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Federal University of Rio Grande do Sul, Brazil

Principal Investigators

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Rohde A Luis, Phd

Role: STUDY_CHAIR

Federal University of Rio Grande do Sul

Locations

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Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Related Links

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http://www.ufrgs.br/procab

Program of Bipolar Children and adolescents

Other Identifiers

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19091979

Identifier Type: -

Identifier Source: org_study_id

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