NCT00297739

Brief Summary

Primary objectives:

  1. 1.To assess the short-term efficacy of risperidone augmentation for treatment-resistant aggression in children with ADHD.
  2. 2.To assess the short-term safety and tolerability of risperidone augmentation in the same group of subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2003

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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, 2003

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 1, 2006

Completed
Last Updated

March 16, 2006

Status Verified

March 1, 2006

First QC Date

February 28, 2006

Last Update Submit

March 15, 2006

Conditions

Aggression

Keywords

AggressionADHDAntipsychotic

Outcome Measures

Primary Outcomes (1)

  • Children' Aggression Scale

Secondary Outcomes (1)

  • Clinical Global Impressions

Interventions

RisperidoneDRUG

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Boys and girls ages 7 to 12 years, inclusive
  • Medical/neurological clearance
  • Meets DSM-IV diagnosis of ADHD
  • Treatment with a stimulant medication during the last three weeks
  • Failure to respond to stimulant medication as documented by:
  • Three acts of aggression in the past week, two of which must be acts of physical aggression against other people, objects, or self
  • Aggression Questionnaire (AQ) Predatory-Affective index score of 0 or below. This indicates primarily an affective or impulsive subtype of aggression
  • Minimum CGI scale rating of 4 (moderately ill)
  • IQ \> 75 -

You may not qualify if:

  • Major medical problems such as cardiac, renal, thyroid diseases, and seizure disorder
  • History of alcohol or substance abuse within the last 4 weeks
  • Previous adequate treatment with risperidone (2 mg/day for at least 4 weeks)
  • Acutely suicidal or homicidal
  • Unable to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jorge L. Armenteros, M.D., P.A.

Coral Gables, Florida, 33134, United States

Location

MeSH Terms

Conditions

AggressionAttention Deficit Disorder with Hyperactivity

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial BehaviorAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jorge L Armenteros, MD

    Jorge L. Armenteros, M.D., P.A.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV

Study Record Dates

First Submitted

February 28, 2006

First Posted

March 1, 2006

Study Start

January 1, 2003

Study Completion

April 1, 2005

Last Updated

March 16, 2006

Record last verified: 2006-03

Locations

US(1)