Further Studies of Attention Deficit Disorder - Residual Type (RT)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Further Studies of Attention Deficit Disorder - Residual Type

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Drug: methylphenidate
* Drug: methylphenidate
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 21-55 years; male and female; met Utah Criteria for adult ADHD; 95th or higher percentile on the Parent Rating Scale and/or the Wender Utah Rating Scale; Exclusion Criteria: Patients with other axis-I and axis-II diagnoses were excluded as were patients with significant medical problems.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: a<br>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<br>* Dosing was flexible and dependent on clinical judgement, AEs and treatment response.<br>* Other names: ritalin;|
| Experimental: MPH<br>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<br>* 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<br>* Other names: ritalin;|
| Placebo Comparator: PBO<br>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<br>* Dosing is identical to the MPH arm except that the pills will contain no active medication.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wender-Reimherr Adult Attention Deficit Disorder Scale |  | Monthly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression - Improvement |  | monthly | 
| The Global Assessment of Functioning (GAF). |  | monthly | 
| The Weissman Social Adjustment Scale (WSAS) |  | At termination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, Adult, crossover, randomized, Long-term, Open-label, methylphenidate, Social adjustment