Trial | NCT00693212  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    methylphenidate ...

  • Study Participants

    116
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.
Study Started
Feb 28
1986
Primary Completion
Nov 30
1994
Study Completion
Nov 30
1994
Last Update
Jun 06
2008
Estimate

Drug methylphenidate

Dosing was flexible and dependent on clinical judgement, AEs and treatment response.

  • Other names: ritalin

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 names: ritalin

Drug placebo

Dosing is identical to the MPH arm except that the pills will contain no active medication.

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.

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

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.

Criteria 

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.
No Results Posted