OROS Methylphenidate (Concerta) in the Treatment of Adult ADHD

NCT02215538 | Completed Phase 2 DMC

• 1 other identifier: 00012246
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

This study will look at the effectiveness of osmotic release oral system (OROS) methylphenidate (Concerta) in treating attention deficit hyperactvity disorder (ADHD) in adults. Concerta has received FDA approval for childhood ADHD and there is documentation that it is effective in adult ADHD. However this trial will explore its effectiveness in treating symptoms not a part of the Diagnostic and Statistical Manual-III (DSM-III) criteria. Subjects will experience one screening visit and one baseline visit. Those who meet admission criteria will enter the double-blind phase. This will involve two 4-week treatment periods one of which will involve the use of Concerta and the other a placebo pill. Subjects who complete the double-blind phase will be allowed to enter a 180-day, open-label Concerta phase designed to assess long-term effects.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; adult; WRAADDS; OROS MPH; emotional dysregulation

Outcome Measures

Primary Outcomes (1)

• Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS)

  This is an investigator rated scale which assessed the 7 domains of the Utah Criteria of Adult ADHD

  Baseline visit, Double-blind phase Week 4 each arm, Open-Label months 1-6

Secondary Outcomes (5)

• Clinical Global Impressions-Improvement (CGI-I)

  Baseline; Double-blind phase Week 4 each arm: Open-Label months 1-6

• Clinical Global Impression - Severity (CGI-S)

  Baseline visit; Double-blind phase Week 4 each arm: Open-Label months 1-6

• ADHD rating scale (ADHD-RS)

  Baselinevisit; Double-blind phase Week 4 each arm: Open-Label final visit month 6

• Self Report Wender-Reimherr Adult Attention Deficit Disorder Scale (SR-WRAADDS)

  Baseline; Double-blind phases Week 4 each arm: Final visit of Open-Label period month 6

• Wisconsin Personality Inventory - IV (WISPI-IV)

  Baseline visit; Final Open-Label visit month 6

Study Arms (2)

OROS methylphenidate

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

This arm was identical to the active medication arm except that placebo replaced the active medication.

Drug: Placebo

Interventions

OROS methylphenidate DRUG

Also known as: concerta

OROS methylphenidate

Placebo DRUG

Placebo medication appears identical to the active medication OROS methylphenidate

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults meeting DSM-IV-Text Revision criteria for ADHD, the Utah Criteria for ADHD, and experiencing at least moderate impairment (a score of 4 or greater on the CGI-Severity Scale for ADHD at both Screening and Baseline visits) will be enrolled. Other criteria include:
• Subjects ages 18 to 65, inclusive;
• Female subjects are eligible to enter and participate in this study only if:
• She is of non-childbearing potential; has a male sexual partner who is surgically sterilized; is on implant of levonorgestrel, injectable progesterone, or an oral contraceptive; has an intrauterine device (IUD); or is sexually inactive with a male partner.
• Or agrees to use a double barrier method of contraception (any combination of physical and chemical methods) and has a negative urine pregnancy test at screening interview.
• Subject must be in general good health as determined by medical history, ECG, and other analysis that, in the judgment of the study physician, would confirm the patient's good health.
• Subjects must read and write at a level sufficient to provide written informed consent and complete study-related materials.

You may not qualify if:

• Subjects with other current DSM-IV Axis I Disorders including Current or lifetime history of psychosis, current bipolar disorder type I, current Major Depressive Disorder, and Current Anxiety Disorder (unless in the opinion of clinic physician ADHD is the primary disorder and causes the disability seen in the patient);
• Subjects with any other DSM-IV Axis II diagnosis so severe that it would suggest non-responsiveness to pharmacotherapy for ADHD or noncompliance with the protocol;
• Subjects at risk for suicide or a risk to harm others;
• History of Substance Dependence according to DSM-IV criteria within 3 months of screening;
• Subjects currently abusing illegal drugs or alcohol are excluded from the study;
• Positive urine screen for drugs of abuse at screening for patients who have a significant history of substance use but still meet criteria 4 and 5. Patients not at risk for substance abuse will not be given a urine drug screen;
• Subjects in whom stimulants would represent a risk such as those with a history of stimulant abuse,
• History of uncontrolled hypertension or significant cardiovascular disease;
• Any known or suspected significant medical or psychiatric illnesses (e.g., hepatic or renal insufficiency, pulmonary (asthma, chronic obstructive pulmonary disease, etc), gastrointestinal, endocrine, neurological or metabolic disturbances that, in the judgment of the investigator, may impair interpretation of study results or constitute a significant safety concern in the context of the clinical trial;
• Medications, including health food supplements judged by the investigator to be likely to have central nervous system activity (for example, St John's Wort, gingko leaf, and melatonin), are not permitted during the study. If the subject is taking the medication prior to study entry, there must be a 7 day washout period prior to Visit 2. We will ask for an honest report of all medications consumed between visits. In the event a medication with psychoactive properties is consumed, the patient will be counseled regarding the use of prohibited medications;
• Use of any medication not considered acceptable by the clinical investigator or the medical monitor during the 7-day period before the start of the study (Day 1);

Sponsors & Collaborators

• University of Utah: lead
• McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.: collaborator

Study Sites (1)

Mood Disorders Clinic

Salt Lake City, Utah, 84105, United States

Location

Related Publications (6)

• Marchant BK, Reimherr FW, Halls C, Williams ED, Strong RE. OROS methylphenidate in the treatment of adults with ADHD: a 6-month, open-label, follow-up study. Ann Clin Psychiatry. 2010 Aug;22(3):196-204.

  PMID: 20680193 RESULT

• Reimherr FW, Marchant BK, Williams ED, Strong RE, Halls C, Soni P. Personality disorders in ADHD Part 3: Personality disorder, social adjustment, and their relation to dimensions of adult ADHD. Ann Clin Psychiatry. 2010 May;22(2):103-12.

  PMID: 20445837 RESULT

• Robison RJ, Reimherr FW, Gale PD, Marchant BK, Williams ED, Soni P, Halls C, Strong RE. Personality disorders in ADHD Part 2: The effect of symptoms of personality disorder on response to treatment with OROS methylphenidate in adults with ADHD. Ann Clin Psychiatry. 2010 May;22(2):94-102.

  PMID: 20445836 RESULT

• Williams ED, Reimherr FW, Marchant BK, Strong RE, Halls C, Soni P, Gale PD, Robison RJ. Personality disorder in ADHD Part 1: Assessment of personality disorder in adult ADHD using data from a clinical trial of OROS methylphenidate. Ann Clin Psychiatry. 2010 May;22(2):84-93.

  PMID: 20445835 RESULT

• Reimherr FW, Williams ED, Strong RE, Mestas R, Soni P, Marchant BK. A double-blind, placebo-controlled, crossover study of osmotic release oral system methylphenidate in adults with ADHD with assessment of oppositional and emotional dimensions of the disorder. J Clin Psychiatry. 2007 Jan;68(1):93-101. doi: 10.4088/jcp.v68n0113.

  PMID: 17284136 RESULT

• Gift TE, Reimherr FW, Marchant BK, Steans TA, Wender PH. Personality Disorder in Adult Attention-Deficit/Hyperactivity Disorder: Attrition and Change During Long-term Treatment. J Nerv Ment Dis. 2016 May;204(5):355-63. doi: 10.1097/NMD.0000000000000470.

  PMID: 27082828 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Frederick W Reimherr, MD

  Univeristy of Utah Dept of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Mood Disorders Clinic

Study Record Dates

• First Submitted: August 8, 2014
• First Posted: August 13, 2014
• Study Start: November 1, 2004
• Primary Completion: February 1, 2006
• Study Completion: June 1, 2006
• Last Updated: August 13, 2014

Record last verified: 2014-08

Locations

US (1)