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Completed

NCT Number: NCT00693212

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

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Behavior Mental Disorders Neurodevelopmental Disorders Social Adjustment Social Behavior

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Univ of Utah, School of Medicine, Mood Disorders Clinic

Salt Lake City, Utah, 84132, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Methylphenidate

Drug

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

Other names: ritalin

Placebo

Drug

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

Primary outcomes

  1. Wender-Reimherr Adult Attention Deficit Disorder Scale

    Time frame: Monthly

Secondary outcomes

  1. Clinical Global Impression - Improvement

    Time frame: monthly

  2. The Global Assessment of Functioning (GAF).

    Time frame: monthly

  3. The Weissman Social Adjustment Scale (WSAS)

    Time frame: At termination

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Further Studies of Attention Deficit Disorder - Residual Type

Important dates

Study start
1986
Primary completion
1994
Study completion
1994
First posted
Jun 6, 2008
Registry last updated
Jun 6, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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