Methylphenidate Transdermal System (MTS) in the Treatment of Adult ADHD

NCT00506285 | Completed Phase 3 Results

• 2 other identifiers: 20405SPD485.420-Reimherr
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

This study will look at the effectiveness of Methylphenidate Transdermal System (MTS) in treating adult ADHD. MTS has received FDA approval for childhood ADHD but this is the first trial for adult ADHD. Subjects will experience two screening visits 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 MTS and the other a placebo patch. Subjects who complete the double-blind phase will be allowed to enter a 180-day, open-label MTS phase designed to assess long-term effects.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity Disorder; ADHD; Adult; Methylphenidate Transdermal System; Daytrana

Outcome Measures

Primary Outcomes (1)

• Wender Reimherr Adult Attention Deficit Disorder Scale

  This scale measures the 7 domains of the Utah Criteria for Adult ADHD. Total scores run from 0 to 28. Normative samples average below 5. The worst possible score is 28.

  Double-blind endpoints during MTS and placebo arms

Secondary Outcomes (1)

• Conners' Adult ADHD Rating Scales (CAARS)

  Double-blind endpoints for MTS and placebo arms

Study Arms (2)

A

EXPERIMENTAL

This arm was 4 weeks long. Subjects were treated using Methylphenidate Transdermal System. Patients were seen weekly, phone contact was made between visits and dosing could be adjusted as a result of the phone contact. MTS was initiated using a 12.5 cm patch. The dose was increased during the first 2 weeks based on treatment response and side effects to the largest tolerated dose/patch size. It was held steady the last 2 weeks.

Drug: Methylphenidate Transdermal System (MTS)

B

PLACEBO COMPARATOR

This arm was 4 weeks long. Placebo patch was initiated using a 12.5 cm patch and then increased to the largest tolerated patch size during the first 2 weeks and held steady the last two weeks. Subjects were seen weekly, phone contact was made between visits and dosing could be adjusted as a result of the phone visit.

Other: placebo patch

Interventions

Methylphenidate Transdermal System (MTS) DRUG

MTS is an advanced patch product that provides methylphenidate evenly mixed with the adhesive. This formulation allows good adhesion and a wide range of dose sizes. MTS patch sizes of 12.5, 18.75, 25 and 37.5cm2 are equivalent to nominal doses over a 9-hour wear time of 10, 15, 20 and 30mg of MPH.

Also known as: Daytrana

A

placebo patch OTHER

This patch is designed to appear identical to the actual intervention patch

B

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, COPD, 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);
• Subjects with high BMI (\>38) and those with high adipose tissue concentrations in the hip as judged by the clinician.

Sponsors & Collaborators

• University of Utah: lead
• Shire: collaborator

Study Sites (1)

University of Utah School of Medicine, Department of Psychiatry, Mood Disorders Clinic

Salt Lake City, Utah, 84132, United States

Location

Related Publications (3)

• Olsen JL, Reimherr FW, Marchant BK, Wender PH, Robison RJ. The effect of personality disorder symptoms on response to treatment with methylphenidate transdermal system in adults with attention-deficit/hyperactivity disorder. Prim Care Companion CNS Disord. 2012;14(5):PCC.12m01344. doi: 10.4088/PCC.12m01344. Epub 2012 Oct 11.

  PMID: 23469326 BACKGROUND

• Reimherr FW, Marchant BK, Olsen JL, Wender PH, Robison RJ. Oppositional defiant disorder in adults with ADHD. J Atten Disord. 2013 Feb;17(2):102-13. doi: 10.1177/1087054711425774. Epub 2011 Nov 18.

  PMID: 22100691 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

Results Point of Contact

• Title: Barrie K. Marchant
• Organization: Psychiatry Research Clinic

barriemarchant@aol.com

801 585-6663

Study Officials

• Frederick W. Reimherr, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: July 23, 2007
• First Posted: July 25, 2007
• Study Start: June 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: January 16, 2015
• Results First Posted: January 16, 2015

Record last verified: 2015-01

Locations

US (1)