Methylphenidate for Attention Deficit Hyperactivity Disorder and Autism in Children
This study has been completed.
Sponsor:
The University of Texas Health Science Center, Houston
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
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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
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
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
| 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) ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| 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. |
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 |
|---|
| 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. |
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
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 |