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| Sponsor: | University of Utah |
|---|---|
| Collaborator: |
National Institute of Mental Health (NIMH) |
| Information provided by: | University of Utah |
| ClinicalTrials.gov Identifier: | NCT00693212 |
Purpose
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 |
|---|---|---|
|
Attention Deficit Hyperactivity Disorder |
Drug: methylphenidate Drug: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
|---|---|
|
Experimental: a
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.
Other Name: ritalin
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Experimental: MPH
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
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
Other Name: ritalin
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Placebo Comparator: PBO
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.
Eligibility| Ages Eligible for Study: | 21 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Paul H. Wender MD Director Mood Disorders Clinic, University of Utah; Mood Disorders Clinic |
| ClinicalTrials.gov Identifier: | NCT00693212 History of Changes |
| Other Study ID Numbers: | IRB 1491 |
| Study First Received: | June 3, 2008 |
| Last Updated: | June 5, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
ADHD Adult crossover randomized |
Long-term Open-label methylphenidate Social adjustment |
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Methylphenidate |
Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
