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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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00825552
Enrollment
20
Registered
2009-01-21
Start date
2009-01-31
Completion date
2010-11-30
Last updated
2009-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Mood Dysregulation

Keywords

Risperidone, Severe mood dysregulation, bipolar, children

Brief summary

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

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.

Interventions

DRUGRisperidone

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

Sponsors

Federal University of Rio Grande do Sul
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Bipolar disorder * IQ\<70 * Psychosis

Design outcomes

Primary

MeasureTime frame
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 symptoms11/2010

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026