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

Sponsors and Collaborators:	University of Utah National Institute of Mental Health (NIMH)
Information provided by:	University of Utah
ClinicalTrials.gov Identifier:	NCT00693212

Purpose

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.

Condition	Intervention	Phase
Attention Deficit Hyperactivity Disorder	Drug: methylphenidate Drug: placebo	Phase III

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Methylphenidate hydrochloride Methylphenidate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Further Studies of Attention Deficit Disorder - Residual Type

Further study details as provided by University of Utah:

Primary Outcome Measures:

Wender-Reimherr Adult Attention Deficit Disorder Scale [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical Global Impression - Improvement [ Time Frame: monthly ] [ Designated as safety issue: No ]
The Global Assessment of Functioning (GAF). [ Time Frame: monthly ] [ Designated as safety issue: No ]
The Weissman Social Adjustment Scale (WSAS) [ Time Frame: At termination ] [ Designated as safety issue: No ]

Enrollment:	116
Study Start Date:	February 1986
Study Completion Date:	November 1994
Primary Completion Date:	November 1994 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Dosing was flexible and dependent on clinical judgement, AEs and treatment response.
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 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.	Drug: placebo Dosing is identical to the MPH arm except that the pills will contain no active medication.

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.

Eligibility

Ages Eligible for Study:	21 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00693212

Locations

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

Sponsors and Collaborators

University of Utah

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Paul H Wender, MD

University of Utah

More Information

Responsible Party:	University of Utah; Mood Disorders Clinic ( Paul H. Wender MD Director Mood Disorders Clinic )
Study ID Numbers:	IRB 1491
Study First Received:	June 3, 2008
Last Updated:	June 5, 2008
ClinicalTrials.gov Identifier:	NCT00693212
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Utah:

ADHD
Adult
crossover
randomized

Long-term
Open-label
methylphenidate
Social adjustment

Study placed in the following topic categories:

Signs and Symptoms
Dopamine
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood

Methylphenidate
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Disease
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs

Central Nervous System Stimulants
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009