Methylphenidate for Attention Deficit Hyperactivity Disorder and Autism in Children

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Deborah Pearson, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00178503
First received: September 12, 2005
Last updated: May 6, 2013
Last verified: May 2013
Results First Received: January 14, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Autism
Attention Deficit Disorder With Hyperactivity
Interventions: Drug: Methylphenidate-extended release
Drug: Methylphenidate-immediate release
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from January of 2006 to March of 2010. Sources of recruitment included our UT Department of Psychiatry Clinics, research registry, along with community referrals from local agencies, parent groups, and schools.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
129 children completed the initial psychological/screening assessment to confirm study eligibility. Of those 129 children, 94 children met full inclusion/exclusion criteria for the initial phase project. Of these, 28 were invited to participate in the MPH trial and 24 of these children were randomized into the trial.

Reporting Groups
  Description
MPH Trial 24 participants with autism spectrum disorder and ADHD underwent a randomized, placebo-controlled, cross-over designed trial, which included: 1 week of placebo, 1 week of low dose methylphenidate, 1 week of medium dose methylphenidate, 1 week of high dose methylphenidate.

Participant Flow for 4 periods

Period 1:   MPH Trial: Placebo
    MPH Trial  
STARTED     24  
COMPLETED     24  
NOT COMPLETED     0  

Period 2:   MPH Trial: Low Dose
    MPH Trial  
STARTED     24  
COMPLETED     24  
NOT COMPLETED     0  

Period 3:   MPH Trial: Med Dose
    MPH Trial  
STARTED     24  
COMPLETED     24  
NOT COMPLETED     0  

Period 4:   MPH Trial: High Dose
    MPH Trial  
STARTED     24  
COMPLETED     24  
NOT COMPLETED     0  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
MPH Trial 24 Participants with ASD-ADHD underwent 1 week of placebo, 1 week of Low dose, 1 week of Medium dose, and 1 week of High dose in the MPH treatment phase

Baseline Measures
    MPH Trial  
Number of Participants  
[units: participants]
  24  
Age  
[units: participants]
 
<=18 years     24  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  8.8  ± 1.7  
Gender  
[units: participants]
 
Female     5  
Male     19  
Region of Enrollment  
[units: participants]
 
United States     24  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Conners' Teacher ADHD Index T Score by Dose   [ Time Frame: Measured at each dosing week of the drug trial (placebo, low, medium, high) ]

2.  Primary:   Mean Continuous Performance Test (CPT)-Commission Errors by Dose   [ Time Frame: Measured at each dosing week of the drug trial (placebo, low, medium, high) ]

3.  Secondary:   Mean Conners' Parent ADHD Index T Score by Week   [ Time Frame: Measured at each dosing week of the drug trial (placebo, low, medium, high) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
We did not have teacher behavioral data for all of the children because some of them were seen during the summer, when teacher input was not available.


  More Information
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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: Deborah A. Pearson, Ph.D.
Organization: University of Texas Medical School at Houston
phone: 713-486-2588
e-mail: Deborah.A.Pearson@uth.tmc.edu


No publications provided


Responsible Party: Deborah Pearson, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00178503     History of Changes
Other Study ID Numbers: R01 MH072263, R01MH072263, DDTR B2-NDA
Study First Received: September 12, 2005
Results First Received: January 14, 2013
Last Updated: May 6, 2013
Health Authority: United States: Federal Government