Pharmacological Treatment of Children and Adolescents Wit... | NCT00825552

Studies
Pharmacological Treatment of Children and Adolescents With Severe Mood Dysregulation

NCT00825552

Sponsor

Federal University of Rio Grande do Sul

Status

Unknown status

Last Update Posted

Jan 21, 2009Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Severe Mood Dysregulation

Interventions

Risperidone

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jan 2010Estimated

Completion Date

Nov 2010Estimated

First Submitted Date

Jan 16, 2009

First Submission Date that Met QC Criteria

Jan 20, 2009

First Posted Date

Jan 21, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2009

Last Update Posted Date

Jan 21, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Name	Type	Description	Arm Group Labels	Other Names
Risperidone	Drug	0,5-4 mg/day for 8 weeks (twice a day)

Outcomes Module

Primary Outcomes

Measure	Description	Time 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 symptoms		11/2010

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Bipolar disorder
IQ<70
Psychosis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rohde A Luis, Phd	Federal University of Rio Grande do Sul	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Clinicas de Porto Alegre		Porto Alegre	Rio Grande do Sul	90000-010	Brazil
Hospital de Clinicas de Porto Alegre

Label	URL
Program of Bipolar Children and adolescents	View source

Intervention Browse Module

MeSH Terms

ID	Term
D018967	Risperidone

Ancestor Terms

ID	Term
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided