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

NCT00693212 | Completed Phase 3

• 1 other identifier: IRB 1491
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Wender-Reimherr Adult Attention Deficit Disorder Scale

  Monthly

Secondary Outcomes (3)

• Clinical Global Impression - Improvement

  monthly

• The Global Assessment of Functioning (GAF).

  monthly

• The Weissman Social Adjustment Scale (WSAS)

  At termination

Study Arms (3)

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.

Drug: methylphenidate

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

Drug: methylphenidate

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.

Drug: placebo

Interventions

methylphenidate DRUG

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

Also known as: ritalin

a

placebo DRUG

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

PBO

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• Patients with other axis-I and axis-II diagnoses were excluded as were patients with significant medical problems.

Sponsors & Collaborators

• University of Utah: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Univ of Utah, School of Medicine, Mood Disorders Clinic

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Social Adjustment

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Paul H Wender, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Expanded Access: Yes

Study Record Dates

• First Submitted: June 3, 2008
• First Posted: June 6, 2008
• Study Start: February 1, 1986
• Primary Completion: November 1, 1994
• Study Completion: November 1, 1994
• Last Updated: June 6, 2008

Record last verified: 2008-06

Locations

US (1)