A Phase 3 interventional study of methylphenidate and methylphenidate in Attention Deficit Hyperactivity Disorder, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 21 Years to 55 Years. Per ClinicalTrials.gov, last updated 2008-06-06.
Sponsored by University of Utah · Phase 3, Interventional, and Treatment
The first phase was a double-blind crossover design of methylphenidate in the treatment of adult ADHD. The second phase consisted of an open-label extension trial of methylphenidate in adult ADHD. It was hypothesized that methylphenidate would prove more effective than placebo in treating ADHD symptoms during the first phase. It was also hypothesized that methylphenidate responders from the double-blind trial would continue to benefit from treatment in the second phase. Improvement would include both ADHD symptoms and social adjustment.
All patients received a single-blind week on placebo, followed by a double-blind random assignment crossover trial of methylphenidate and placebo, with each double-blind phase lasting two weeks. Subjects who experienced moderate or marked improvement on methylphenidate would be allowed to enter a long-term, open-label trial. ADHD symptom severity was measured monthly by a structured interview, the Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS), Clinical Global Impression - Improvement (CGI-I) and Global Assessment of Functioning (GAF). Social functioning was assessed by the clinician administered version of the Weissman Social Adjustment Scale (WSAS). Dosing was determined by clinical judgement, symptom improvement and AEs.
1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.
This study's enrollment of 116 is above the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.
Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.
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Exclusion Criteria:
This arm was only open to subjects entering the second, open-label phase. All subjects were given open-label methylphenidate. Dosing was flexible.
Drug: methylphenidate
This is the active treatment arm of the double-blind placebo controlled phase. Patients were begun at 10 mg t.i.d. and the dose increased as necessary until a maximum dose of 60 mg/day was administered. Frequency could be increased and some patients had dosage schedules of 4 to 6 times per day
Drug: methylphenidate
This 2 week arm is the placebo part of the crossover design. Subjects receive placebo in a manner similar to the MPH arm. It lasts 2 weeks.
Drug: placebo
Dosing was flexible and dependent on clinical judgement, AEs and treatment response.
Also known as: ritalin
Patients were begun at 10 mg t.i.d. and the dose increased as necessary until a maximum dose of 60 mg/day was administered. Frequency could be increased and some patients had dosage schedules of 4 to 6 times per day
Also known as: ritalin
Dosing is identical to the MPH arm except that the pills will contain no active medication.
Wender-Reimherr Adult Attention Deficit Disorder Scale
Time frame: Monthly
Clinical Global Impression - Improvement
Time frame: monthly
The Global Assessment of Functioning (GAF).
Time frame: monthly
The Weissman Social Adjustment Scale (WSAS)
Time frame: At termination
This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.
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Attention Deficit Disorder with Hyperactivity→
University of Utah