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

NCT ID: NCT00693212

Last Updated: 2008-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1986-02-28
• Study Completion Date: 1994-11-30

Brief Summary

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

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; Adult; crossover; randomized; Long-term; Open-label; methylphenidate; Social adjustment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

a

This arm was only open to subjects entering the second, open-label phase. All subjects were given open-label methylphenidate. Dosing was flexible.

Group Type: EXPERIMENTAL

methylphenidate

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

methylphenidate

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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

Interventions

methylphenidate

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

Intervention Type: 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

Intervention Type: DRUG

placebo

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

Intervention Type: DRUG

Other Intervention Names

ritalin; ritalin

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

University of Utah; Mood Disorders Clinic

Principal Investigators

Paul H Wender, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

Univ of Utah, School of Medicine, Mood Disorders Clinic

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

IRB 1491

Identifier Type: -

Identifier Source: org_study_id