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Sponsors and Collaborators: |
University of Utah National Institute of Mental Health (NIMH) |
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Information provided by: | University of Utah |
ClinicalTrials.gov Identifier: | NCT00693212 |
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.
Condition | Intervention | Phase |
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Attention Deficit Hyperactivity Disorder |
Drug: methylphenidate Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Further Studies of Attention Deficit Disorder - Residual Type |
Enrollment: | 116 |
Study Start Date: | February 1986 |
Study Completion Date: | November 1994 |
Primary Completion Date: | November 1994 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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a: Experimental
This arm was only open to subjects entering the second, open-label phase. All subjects were given open-label methylphenidate. Dosing was flexible.
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Drug: methylphenidate
Dosing was flexible and dependent on clinical judgement, AEs and treatment response.
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MPH: Experimental
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
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Drug: methylphenidate
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
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PBO: Placebo Comparator
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.
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Drug: placebo
Dosing is identical to the MPH arm except that the pills will contain no active medication.
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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.
Ages Eligible for Study: | 21 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Utah | |
Univ of Utah, School of Medicine, Mood Disorders Clinic | |
SLC, Utah, United States, 84132 |
Principal Investigator: | Paul H Wender, MD | University of Utah |
Responsible Party: | University of Utah; Mood Disorders Clinic ( Paul H. Wender MD Director Mood Disorders Clinic ) |
Study ID Numbers: | IRB 1491 |
Study First Received: | June 3, 2008 |
Last Updated: | June 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00693212 |
Health Authority: | United States: Food and Drug Administration |
ADHD Adult crossover randomized |
Long-term Open-label methylphenidate Social adjustment |
Signs and Symptoms Dopamine Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood |
Methylphenidate Neurologic Manifestations Attention Deficit and Disruptive Behavior Disorders Hyperkinesis Dyskinesias |
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Disease Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs |
Central Nervous System Stimulants Pharmacologic Actions Pathologic Processes Therapeutic Uses Dopamine Agents Central Nervous System Agents |