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

Condition(s) targeted: Attention Deficit Hyperactivity Disorder

Intervention: methylphenidate (Drug); methylphenidate (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: University of Utah

Official(s) and/or principal investigator(s):
Paul H Wender, MD, Principal Investigator, Affiliation: University of Utah

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.

Official title: Further Studies of Attention Deficit Disorder - Residual Type

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study

Primary outcome: Wender-Reimherr Adult Attention Deficit Disorder Scale

Secondary outcome:

Clinical Global Impression - Improvement

The Global Assessment of Functioning (GAF).

The Weissman Social Adjustment Scale (WSAS)

Detailed description: 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.

Minimum age: 21 Years. Maximum age: 55 Years. Gender(s): Both.

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.

Univ of Utah, School of Medicine, Mood Disorders Clinic, SLC, Utah 84132, United States

Starting date: February 1986
Ending date: November 1994
Last updated: June 5, 2008