Further Studies of Attention Deficit Disorder - Residual Type (RT)
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|ClinicalTrials.gov Identifier: NCT00693212|
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : June 6, 2008
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder||Drug: methylphenidate Drug: placebo||Phase 3|
Expanded Access : University of Utah has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||116 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Further Studies of Attention Deficit Disorder - Residual Type|
|Study Start Date :||February 1986|
|Actual Primary Completion Date :||November 1994|
|Actual Study Completion Date :||November 1994|
This arm was only open to subjects entering the second, open-label phase. All subjects were given open-label methylphenidate. Dosing was flexible.
Dosing was flexible and dependent on clinical judgement, AEs and treatment response.
Other Name: ritalin
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
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.
Dosing is identical to the MPH arm except that the pills will contain no active medication.
- Wender-Reimherr Adult Attention Deficit Disorder Scale [ Time Frame: Monthly ]
- Clinical Global Impression - Improvement [ Time Frame: monthly ]
- The Global Assessment of Functioning (GAF). [ Time Frame: monthly ]
- The Weissman Social Adjustment Scale (WSAS) [ Time Frame: At termination ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00693212
|United States, Utah|
|Univ of Utah, School of Medicine, Mood Disorders Clinic|
|SLC, Utah, United States, 84132|
|Principal Investigator:||Paul H Wender, MD||University of Utah|