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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00693212
First received: June 3, 2008
Last updated: June 5, 2008
Last verified: June 2008
  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 3

University of Utah has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Further Studies of Attention Deficit Disorder - Residual Type

Resource links provided by NLM:


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
Experimental: a
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.
Other Name: ritalin
Experimental: 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
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
Other Name: ritalin
Placebo Comparator: 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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Paul H Wender, MD University of Utah
  More Information

No publications provided

Responsible Party: Paul H. Wender MD Director Mood Disorders Clinic, University of Utah; Mood Disorders Clinic
ClinicalTrials.gov Identifier: NCT00693212     History of Changes
Other Study ID Numbers: IRB 1491
Study First Received: June 3, 2008
Last Updated: June 5, 2008
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

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Methylphenidate
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014