Treatment of Severe Childhood Aggression (The TOSCA Study)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Michael Aman, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00796302
First received: November 21, 2008
Last updated: May 18, 2016
Last verified: May 2016
Results First Received: February 18, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Attention Deficit Disorder With Hyperactivity
Interventions: Drug: Methylphenidate HCl
Drug: Risperidone
Behavioral: Parent Management Training (PMT)
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
256 participants were screened. 188 passed screening.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Between initial contact and randomization, 108 potential participants were lost for the following reasons: 68 subjects failed screen criteria, 4 were ineligible at Baseline, 10 withdrew consent, 4 were lost to follow-up, and 2 were unable to swallow medication.

Reporting Groups
  Description
Basic (Stimulant + PMT + Placebo) Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
Augmented (Stimulant + PMT + Risperidone) Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training.

Participant Flow:   Overall Study
    Basic (Stimulant + PMT + Placebo)     Augmented (Stimulant + PMT + Risperidone)  
STARTED     84     84  
COMPLETED     71     66  
NOT COMPLETED     13     18  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ADHD & severe physical aggression

Reporting Groups
  Description
Basic (Stimulant + PMT + Placebo) Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
Augmented (Stimulant + PMT + Risperidone) Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training.
Total Total of all reporting groups

Baseline Measures
    Basic (Stimulant + PMT + Placebo)     Augmented (Stimulant + PMT + Risperidone)     Total  
Number of Participants  
[units: participants]
  84     84     168  
Age  
[units: participants]
     
<=18 years     84     84     168  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  8.8  (1.98)     9.0  (2.05)     8.9  (2.01)  
Gender  
[units: participants]
     
Female     20     19     39  
Male     64     65     129  
Region of Enrollment  
[units: participants]
     
United States     84     84     168  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   NCBRF-TIQ D-Total Score   [ Time Frame: Measured at baseline and Weeks 3, 4, 5, 6, 7, 8, 9 ]

2.  Other Pre-specified:   Antisocial Behavior Scale - Reactive Aggression Subscale   [ Time Frame: Measured at baseline and Week 9 ]

3.  Other Pre-specified:   Clinical Global Impressions Scale for Improvement   [ Time Frame: Measured at endpoint visit ]

4.  Other Pre-specified:   Clinical Global Impressions Scale for Severity of Illness   [ Time Frame: Measured at endpoint visit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
These results were obtained with children selected for severity of aggression and disruptive behavior, and the risk-benefit ratio may well be decreased for children with milder disruptive behavior or no physical aggression.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Michael Aman
Organization: Ohio State University
phone: 614-688-4196
e-mail: Aman.1@osu.edu


Publications of Results:


Responsible Party: Michael Aman, The Ohio State University
ClinicalTrials.gov Identifier: NCT00796302     History of Changes
Other Study ID Numbers: R01MH077907 ( US NIH Grant/Contract Award Number )
DSIR 84-CTS
1R01MH077907-01A2 ( US NIH Grant/Contract Award Number )
1R01MH077676-01A2 ( US NIH Grant/Contract Award Number )
1R01MH077750-01A2 ( US NIH Grant/Contract Award Number )
1R01MH077997-01A2 ( US NIH Grant/Contract Award Number )
Study First Received: November 21, 2008
Results First Received: February 18, 2016
Last Updated: May 18, 2016
Health Authority: United States: Federal Government