NCT00825552

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 21, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

January 21, 2009

Status Verified

January 1, 2009

Enrollment Period

1 year

First QC Date

January 16, 2009

Last Update Submit

January 20, 2009

Conditions

Severe Mood Dysregulation

Keywords

RisperidoneSevere mood dysregulationbipolarchildren

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

RisperidoneDRUG

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

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnose of Severe Mood Dysregulation
  • years
  • IQ \> 70

You may not qualify if:

  • Bipolar disorder
  • IQ\<70
  • Psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90000-010, Brazil

Location

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90350-903, Brazil

Location

Related Links

MeSH Terms

Interventions

Risperidone

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Rohde A Luis, Phd

    Federal University of Rio Grande do Sul

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 16, 2009

First Posted

January 21, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2010

Study Completion

November 1, 2010

Last Updated

January 21, 2009

Record last verified: 2009-01

Locations

BR(2)