OROS Methylphenidate (Concerta) in the Treatment of Adult ADHD
|ClinicalTrials.gov Identifier: NCT02215538|
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : August 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder||Drug: OROS methylphenidate Drug: Placebo||Phase 2 Phase 3|
ADHD affects from 3 to 5% of children, persists into adolescence 40 to 70% of these children and continues into adulthood in at least 50% of affected adolescents. Pharmacotherapy for ADHD in adults has paralleled that used for children, with generally positive results (Spencer, 1998). Never-the-less, it is not clear that the dimensions of medication response in adults are the same as in children. The extent to which the symptoms change with age remains open to question. This trial is created to include a variety of outcome measures which will enhance the number of symptoms assessed.
Methylphenidate was the first medication shown to be effective in treatment for adults with ADHD and continues to be widely used. Several studies have demonstrated the usefulness of methylphenidate in adult ADHD (Wender et al, 1985, Spencer et al, 1995). These studies have not shown any unexpected drawbacks to treatment with methylphenidate. The extended release formulations represent an improvement over the immediate release versions for many patients.
This is a double-blind, placebo-controlled, randomized, crossover trial comparing OROS methylphenidate with placebo. The double-blind trial will be preceded by an enrollment period consisting of a screening visit followed by a baseline visit. Patients who continue to meet admission criteria at baseline will be randomized into the first of two 4-week treatment periods. We will attempt to reach the highest tolerated dose size within 2 weeks and then observe the response over the last two weeks of each crossover phase. The double-blind period will be followed by a 180 day open-treatment, flexible-dose phase designed to assess long-term effects.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Concerta in the Treatment of Adult ADHD and a Comparison of Four Adult ADHD Scales and Effects on Personality|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||February 2006|
|Actual Study Completion Date :||June 2006|
Experimental: OROS methylphenidate
This was a 4-week double-blind arm. Medication was initiated at 18 mg/day and increased every 2 or 3 days by 9 mg based on treatment response and side effects. Maximum dose - 90 mg/day. Patients were seen weekly. Generally a stable dose was seen in 2 weeks and maintained the last 2 weeks of the arm. Side effects were assessed at each visit.
Drug: OROS methylphenidate
Other Name: concerta
Placebo Comparator: placebo
This arm was identical to the active medication arm except that placebo replaced the active medication.
Placebo medication appears identical to the active medication OROS methylphenidate
- Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) [ Time Frame: Baseline visit, Double-blind phase Week 4 each arm, Open-Label months 1-6 ]This is an investigator rated scale which assessed the 7 domains of the Utah Criteria of Adult ADHD
- Clinical Global Impressions-Improvement (CGI-I) [ Time Frame: Baseline; Double-blind phase Week 4 each arm: Open-Label months 1-6 ]This is a global measure in improvement in symptoms that is a Likert type scale
- Clinical Global Impression - Severity (CGI-S) [ Time Frame: Baseline visit; Double-blind phase Week 4 each arm: Open-Label months 1-6 ]This is a general measure of symptom severity assessed using a Likert type scale.
- ADHD rating scale (ADHD-RS) [ Time Frame: Baselinevisit; Double-blind phase Week 4 each arm: Open-Label final visit month 6 ]This is an investigator rated scale which assesses the DSM-IV symptoms.
- Self Report Wender-Reimherr Adult Attention Deficit Disorder Scale (SR-WRAADDS) [ Time Frame: Baseline; Double-blind phases Week 4 each arm: Final visit of Open-Label period month 6 ]This is a patient rated scale that assesses the 7 domains of the Utah Criteria for adult ADHD as well as ODD, Social functioning and Learning difficulties.
- Wisconsin Personality Inventory - IV (WISPI-IV) [ Time Frame: Baseline visit; Final Open-Label visit month 6 ]This is a computerized personality inventory completed by the patients. It consists of 214 items which address the 10 DSM-IV personality disorders plus passive aggressive personality disorder.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215538
|United States, Utah|
|Mood Disorders Clinic|
|Salt Lake City, Utah, United States, 84105|
|Principal Investigator:||Frederick W Reimherr, MD||Univeristy of Utah Dept of Psychiatry|