Trial Outcomes & Findings for Methylphenidate for Attention Deficit Hyperactivity Disorder and Autism in Children (NCT NCT00178503)

Last Updated: 2013-05-09

Results Overview

The ADHD Index of the Conners' Teacher Rating Scale-Revised (CTRS-R) assesses symptoms associated with ADHD, including inattentiveness, hyperactivity and impulsivity. Lower T-scores on this subscale are associated with milder ADHD symptoms. T-scores have a mean of 50 and a SD of 10. Thus, T-scores of 70+ (i.e., 2 SD's over the mean) on the ADHD Index are suggestive of very significant ADHD symptomatology. Treatment-related changes of 5+ points are considered to be significant.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

24 participants

Primary outcome timeframe

Measured at each dosing week of the drug trial (placebo, low, medium, high)

Results posted on

2013-05-09

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
MPH Trial: Placebo STARTED	24
MPH Trial: Placebo COMPLETED	24
MPH Trial: Placebo NOT COMPLETED	0
MPH Trial: Low Dose STARTED	24
MPH Trial: Low Dose COMPLETED	24
MPH Trial: Low Dose NOT COMPLETED	0
MPH Trial: Med Dose STARTED	24
MPH Trial: Med Dose COMPLETED	24
MPH Trial: Med Dose NOT COMPLETED	0
MPH Trial: High Dose STARTED	24
MPH Trial: High Dose COMPLETED	24
MPH Trial: High Dose NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Methylphenidate for Attention Deficit Hyperactivity Disorder and Autism in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MPH Trial n=24 Participants 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
Age, Categorical <=18 years	24 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	8.8 years STANDARD_DEVIATION 1.7 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at each dosing week of the drug trial (placebo, low, medium, high)

Population: Although there were 24 participants who completed the trial, teacher ratings were only available for 18 participants due to 6 children being seen during the summer months.

Outcome measures

Outcome measures
Measure	MPH Trial-Placebo Week n=18 Participants All 24 participants with ASD-ADHD underwent 1 week of placebo in the MPH treatment phase	MPH Trial: Low Dose Week n=18 Participants All 24 participants with ASD-ADHD underwent 1 week at a low dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase	MPH Trial: Med Dose Week n=18 Participants All 24 participants with ASD-ADHD underwent 1 week at a medium dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase	MPH Trial: High Dose Week n=18 Participants All 24 participants with ASD-ADHD underwent 1 week at a high dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phasephase
Mean Conners' Teacher ADHD Index T Score by Dose	72.8 Units on a scale (T-scores) Standard Deviation 12.0	63.1 Units on a scale (T-scores) Standard Deviation 11.2	63.6 Units on a scale (T-scores) Standard Deviation 10.4	61.5 Units on a scale (T-scores) Standard Deviation 13.0

PRIMARY outcome

Timeframe: Measured at each dosing week of the drug trial (placebo, low, medium, high)

CPT is a measure of sustained attention using nonverbal stimuli (pictures). Participants are asked to click on the witch (target), which appears for 25% of the trials. Commission errors are measured by number of times they click for the non-target items.

Outcome measures

Outcome measures
Measure	MPH Trial-Placebo Week n=24 Participants All 24 participants with ASD-ADHD underwent 1 week of placebo in the MPH treatment phase	MPH Trial: Low Dose Week n=24 Participants All 24 participants with ASD-ADHD underwent 1 week at a low dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase	MPH Trial: Med Dose Week n=24 Participants All 24 participants with ASD-ADHD underwent 1 week at a medium dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase	MPH Trial: High Dose Week n=24 Participants All 24 participants with ASD-ADHD underwent 1 week at a high dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phasephase
Mean Continuous Performance Test (CPT)-Commission Errors by Dose	2.75 Total Errors Standard Deviation 3.49	1.11 Total Errors Standard Deviation 1.91	1.18 Total Errors Standard Deviation 1.71	1.24 Total Errors Standard Deviation 2.27

SECONDARY outcome

Timeframe: Measured at each dosing week of the drug trial (placebo, low, medium, high)

The ADHD Index of the Conners' Parent Rating Scale-Revised (CPRS-R) assesses symptoms associated with ADHD, including inattentiveness, hyperactivity and impulsivity. Lower T-scores on this subscale are associated with milder ADHD symptoms. T-scores have a mean of 50 and a SD of 10. Thus, T-scores of 70+ (i.e., 2 SD's over the mean) on the ADHD Index are suggestive of very significant ADHD symptomatology. Treatment-related changes of 5+ points are considered to be significant.

Outcome measures

Outcome measures
Measure	MPH Trial-Placebo Week n=24 Participants All 24 participants with ASD-ADHD underwent 1 week of placebo in the MPH treatment phase	MPH Trial: Low Dose Week n=24 Participants All 24 participants with ASD-ADHD underwent 1 week at a low dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase	MPH Trial: Med Dose Week n=24 Participants All 24 participants with ASD-ADHD underwent 1 week at a medium dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase	MPH Trial: High Dose Week n=24 Participants All 24 participants with ASD-ADHD underwent 1 week at a high dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phasephase
Mean Conners' Parent ADHD Index T Score by Week	70.1 Units on a scale (T-scores) Standard Deviation 12.0	64.9 Units on a scale (T-scores) Standard Deviation 9.3	62.3 Units on a scale (T-scores) Standard Deviation 10.0	59.9 Units on a scale (T-scores) Standard Deviation 10.5

Adverse Events

MPH Trial-Placebo

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

MPH Trial: Low Dose

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

MPH Trial: Med Dose

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

MPH Trial: High Dose

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Deborah A. Pearson, Ph.D.

University of Texas Medical School at Houston

Phone: 713-486-2588

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	MPH Trial-Placebo n=24 participants at risk Participants with ASD-ADHD who will undergo 1 week of placebo in the MPH treatment phase	MPH Trial: Low Dose n=24 participants at risk Participants with ASD-ADHD who will undergo 1 week at a low dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase	MPH Trial: Med Dose n=24 participants at risk Participants with ASD-ADHD who will undergo 1 week at a medium dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase	MPH Trial: High Dose n=24 participants at risk Participants with ASD-ADHD who will undergo 1 week at a high dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
Psychiatric disorders Repetitive Behaviors	50.0% 12/24 • over 4 weeks of the trial	45.8% 11/24 • over 4 weeks of the trial	50.0% 12/24 • over 4 weeks of the trial	37.5% 9/24 • over 4 weeks of the trial
Psychiatric disorders Repetitive Language	50.0% 12/24 • over 4 weeks of the trial	37.5% 9/24 • over 4 weeks of the trial	50.0% 12/24 • over 4 weeks of the trial	37.5% 9/24 • over 4 weeks of the trial
Psychiatric disorders Irritability	45.8% 11/24 • over 4 weeks of the trial	33.3% 8/24 • over 4 weeks of the trial	33.3% 8/24 • over 4 weeks of the trial	29.2% 7/24 • over 4 weeks of the trial
Psychiatric disorders Anxiety	16.7% 4/24 • over 4 weeks of the trial	16.7% 4/24 • over 4 weeks of the trial	25.0% 6/24 • over 4 weeks of the trial	8.3% 2/24 • over 4 weeks of the trial
Psychiatric disorders Sadness	12.5% 3/24 • over 4 weeks of the trial	8.3% 2/24 • over 4 weeks of the trial	16.7% 4/24 • over 4 weeks of the trial	4.2% 1/24 • over 4 weeks of the trial
Psychiatric disorders Euphoria	4.2% 1/24 • over 4 weeks of the trial	0.00% 0/24 • over 4 weeks of the trial	0.00% 0/24 • over 4 weeks of the trial	0.00% 0/24 • over 4 weeks of the trial
Psychiatric disorders Hair or skin pulling	8.3% 2/24 • over 4 weeks of the trial	4.2% 1/24 • over 4 weeks of the trial	4.2% 1/24 • over 4 weeks of the trial	8.3% 2/24 • over 4 weeks of the trial
Psychiatric disorders Facial or body tics	0.00% 0/24 • over 4 weeks of the trial	4.2% 1/24 • over 4 weeks of the trial	4.2% 1/24 • over 4 weeks of the trial	8.3% 2/24 • over 4 weeks of the trial
Psychiatric disorders Unusual Blinking	0.00% 0/24 • over 4 weeks of the trial	4.2% 1/24 • over 4 weeks of the trial	4.2% 1/24 • over 4 weeks of the trial	0.00% 0/24 • over 4 weeks of the trial
Psychiatric disorders Trouble sleeping	20.8% 5/24 • over 4 weeks of the trial	29.2% 7/24 • over 4 weeks of the trial	50.0% 12/24 • over 4 weeks of the trial	37.5% 9/24 • over 4 weeks of the trial
Skin and subcutaneous tissue disorders skin rash	0.00% 0/24 • over 4 weeks of the trial	4.2% 1/24 • over 4 weeks of the trial	4.2% 1/24 • over 4 weeks of the trial	4.2% 1/24 • over 4 weeks of the trial
Gastrointestinal disorders Stomach ache	4.2% 1/24 • over 4 weeks of the trial	4.2% 1/24 • over 4 weeks of the trial	12.5% 3/24 • over 4 weeks of the trial	8.3% 2/24 • over 4 weeks of the trial
Gastrointestinal disorders Loss of Appetite	4.2% 1/24 • over 4 weeks of the trial	29.2% 7/24 • over 4 weeks of the trial	37.5% 9/24 • over 4 weeks of the trial	37.5% 9/24 • over 4 weeks of the trial
Metabolism and nutrition disorders Dry Mouth	0.00% 0/24 • over 4 weeks of the trial	4.2% 1/24 • over 4 weeks of the trial	8.3% 2/24 • over 4 weeks of the trial	0.00% 0/24 • over 4 weeks of the trial
Nervous system disorders Staring	16.7% 4/24 • over 4 weeks of the trial	0.00% 0/24 • over 4 weeks of the trial	8.3% 2/24 • over 4 weeks of the trial	4.2% 1/24 • over 4 weeks of the trial
Cardiac disorders Racing heart	0.00% 0/24 • over 4 weeks of the trial	0.00% 0/24 • over 4 weeks of the trial	4.2% 1/24 • over 4 weeks of the trial	0.00% 0/24 • over 4 weeks of the trial
Nervous system disorders Drowsiness	4.2% 1/24 • over 4 weeks of the trial	4.2% 1/24 • over 4 weeks of the trial	4.2% 1/24 • over 4 weeks of the trial	8.3% 2/24 • over 4 weeks of the trial
Gastrointestinal disorders Nausea	4.2% 1/24 • over 4 weeks of the trial	0.00% 0/24 • over 4 weeks of the trial	0.00% 0/24 • over 4 weeks of the trial	0.00% 0/24 • over 4 weeks of the trial
Nervous system disorders Headache	8.3% 2/24 • over 4 weeks of the trial	8.3% 2/24 • over 4 weeks of the trial	16.7% 4/24 • over 4 weeks of the trial	8.3% 2/24 • over 4 weeks of the trial
Immune system disorders Fever	4.2% 1/24 • over 4 weeks of the trial	0.00% 0/24 • over 4 weeks of the trial	0.00% 0/24 • over 4 weeks of the trial	0.00% 0/24 • over 4 weeks of the trial