A Study of Repeat Dosing of OROS® Methylphenidate Hydrochloride (CONCERTA®) and Immediate Release Methylphenidate Hydrochloride in Healthy Adults

NCT00302458 | Completed Phase 4 Results

• 1 other identifier: 2005-P-001812
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This is a double-blind, randomized, placebo-controlled, five-period crossover study to examine the likability of a repeated administration of immediate release methylphenidate hydrochloride (IR-MPH 40 mg) and OROS®-MPH (CONCERTA® 72 mg) in healthy adults. Hypotheses are as follows:

• Hypothesis 1: the subjective feelings of detection and likeability will be greater for periods of IR-MPH administration than after OROS-MPH administration irregardless of sequence;
• Hypothesis 2: the greater ratings of feelings of detection and likeability will be associated with the periods of most rapid change in plasma d-MPH and not with the magnitude of plasma d-MPH concentration (other than the OROS-MPH to IR-MPH condition in which they coincide), and
• Hypothesis 3: the subjective feelings of dislike will be greatest for the two conditions in which IR-MPH is the second condition.

Conditions

Healthy

Keywords

healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Peak Plasma Concentration of d-Methylphenidate

  Objective measure determined from blood samples, measured 4 hours after the dose

  4 hours

Study Arms (5)

OROS-MPH + OROS-MPH

EXPERIMENTAL

OROS-Methylphenidate Will be administered during the first part of the day, and again during the separate part of the day.

Drug: OROS-Methylphenidate

IR MPH + IR MPH

EXPERIMENTAL

Immediate release methylphenidate will be administered in the first part of the day followed by Immediate release methylphenidate in the second part of the day.

Drug: Immediate Release Methylphenidate

Plabebo + Placebo

PLACEBO COMPARATOR

Placebo will be administered during the first part of the day, and again during the second part of the day.

Drug: Placebo

OROS MPH+ IR MPH

EXPERIMENTAL

Concerta will be administered in the first part of the day, followed by Immediate Release Methylphenidate in the second part of the day.

Drug: OROS-Methylphenidate; Drug: Immediate Release Methylphenidate

IR MPH + OROS MPH

EXPERIMENTAL

Immediate release Methylphenidate will be administered in the first part of the day, followed by Concerta in the second part of the day

Drug: OROS-Methylphenidate; Drug: Immediate Release Methylphenidate

Interventions

OROS-Methylphenidate DRUG

Each dose of OROS MPH will be 72 mg which will be supplied as two 36 mg overencapsulated capsules

Also known as: Concerta, OROS MPH

IR MPH + OROS MPH; OROS MPH+ IR MPH; OROS-MPH + OROS-MPH

Immediate Release Methylphenidate DRUG

Each dose of IR MPH will be 40 mg which will be supplied as two 20 mg overencapsulated capsules

Also known as: IR MPH, Ritalin

IR MPH + IR MPH; IR MPH + OROS MPH; OROS MPH+ IR MPH

Placebo DRUG

Placebo will be administered during the first part of the day, and again during the second part of the day.

Plabebo + Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males or non-pregnant, non-lactating females. With the exception of women who have been post-menopausal for a minimum of 12 months prior to screening and those who have undergone hysterectomy or bilateral oophorectomy, all female subjects must have a negative urine pregnancy test at both screening and at each admission to the research unit. All male and female subjects must have used a medically acceptable form of birth control for at least one month prior to screening and be willing to continue use during the study. Medically acceptable forms of birth control include abstinence, hormonal contraceptives, diaphragm with spermicide, condom with spermicide, intrauterine device, or surgical sterilization (including vasectomy of male partner\[s\]).
• Eighteen (18) to 45 years of age, inclusive
• Based on medical history, limited physical examination (neurologic and cardiac) and/or lab results, are considered healthy and free of any conditions that may interfere with participation in the study. Any abnormalities at screening on results of electrocardiogram (ECG) or any laboratory test must be determined to be not clinically significant by an investigator.
• Agree to not use prescription stimulants (except for the study medication) during the study
• Have venous access sufficient for blood sampling as determined by clinical examination
• Weigh at least 100 pounds at screening
• Agree and are available to return to the study center for five full-day (approximately 18 hours) study visits held five to 30 days apart within a 22-week period, and willing to complete all protocol-specified assessments.
• Able to read and comprehend English

You may not qualify if:

• Marked anxiety, tension, and agitation since the drug may aggravate these symptoms
• Known hypersensitivity to methylphenidate or other components of Concerta or Ritalin
• Subjects with glaucoma
• Motor tics or with a family history or diagnosis of Tourette's syndrome
• Treated with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuation of treatment with MAOIs
• Presence or history of any medically diagnosed, clinically significant Axis I psychiatric disorder (including substance use disorders, bipolar disorder, any psychotic disorder)
• Scores of Baseline Scales:
• Hamilton Depression Scale \> 17 (out of a possible 67 on the 21-item scale) (Hamilton 1960)
• Beck Depression Inventory \> 19 (out of a possible 63 on the 21-item scale) (Beck et al 1961)
• Hamilton Anxiety Scale \> 21 (out of a possible 56 on the 14-item scale) (Hamilton 1959)
• Any clinically significant chronic disease or unstable medical abnormality by history or physical examination, including hypertension, hyperthyroidism, a seizure disorder, history of myocardial infarction or stroke, or history of cardiac arrhythmia or heart murmur (other than uncomplicated mitral valve prolapse)
• Clinically significant abnormal baseline laboratory values which include the following:
• Values \> 20% above the upper range of the laboratory standard of a basic metabolic screen and complete blood count
• Currently taking or require any of the following medications:
• Clonidine or other alpha-2 adrenergic receptor agonists

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Ortho-McNeil Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Spencer TJ, Biederman J, Martin JM, Moorehead TM, Mirto T, Clarke A, Batchelder H, Faraone SV. Importance of pharmacokinetic profile and timing of coadministration of short- and long-acting formulations of methylphenidate on patterns of subjective responses and abuse potential. Postgrad Med. 2012 Jan;124(1):166-73. doi: 10.3810/pgm.2012.01.2529.

  PMID: 22314126 DERIVED

MeSH Terms

Interventions

Methylphenidate

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Thomas Spencer
• Organization: Massachusetts General Hospital

spencer@helix.mgh.harvard.edu

617-726-1731

Study Officials

• Thomas Spencer, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Director of the Clinical and Research Program in Pediatric Psychopharmacology

Study Record Dates

• First Submitted: March 13, 2006
• First Posted: March 14, 2006
• Study Start: January 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: February 29, 2016
• Results First Posted: January 7, 2014

Record last verified: 2016-02

Locations

US (1)