Naturalistic Substitution of Concerta in Adult Subject With ADHD Receiving Immediate Release Methylphenidate

NCT00302406 | Completed Phase 4

• 1 other identifier: 2003-P-000038
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-blind study looking at the efficacy and satisfaction of Concerta substitution in adult subjects with ADHD receiving immediate release methylphenidate. Subjects will be administered a maximum dose of 1.3mg/kg/day of either methylphenidate or Concerta. The specific hypotheses of this study are: Hypothesis 1: ADHD symptomatology in adults with DSM-IV, ADHD will continue to be controlled in patients switched from MPH IR TID to Concerta. Hypothesis 2: Patient satisfaction will not decrease in patients switched from MPH IR TID to Concerta (ie., all patients will be equally or more satisfied on Concerta as compared with MPH IR TID.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• Primary Outcomes: maintenance of symptom control when switched from TID IR MPH to Concerta administered once a day in the AM and to assess if this differs from 100%, the value one would expect if Concerta maintained efficacy in all subjects.

Interventions

methylphenidate hydrochloride DRUG

OROS methylphenidate hydrochloride (CONCERTA) DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Signed written informed consent to participate in the study.
• Male and female outpatients older than 18 and younger than 55 years of age.
• If female, non-pregnant, non-nursing with a negative urine pregnancy test and using medically accepted means of birth control (abstinence, birth control pills, IUD, barrier devices, or progesterone rods stabilized for at least three months) while in this study.
• Responders to methylphenidate IR on stable treatment (Stable treatment is defined as a score on the NIMH CGI improvement scale of much or very improved (compared to pre-treatment) from a period of 4 weeks on a stable dose of MPH IR TID).
• Responders to methylphenidate IR on stable treatment who are satisfied with their treatment (satisfaction with treatment is defined as a score of 1 or 2 on the Treatment Satisfaction Rating scale from a period of 4 weeks on a stable dose of MPH IR TID).
• Responders to methylphenidate IR on stable treatment who tolerate their treatment (toleration of treatment is defined as a score on the Tolerability Index of 0 or 1) from a period of 4 weeks on a stable dose of MPH IR TID).
• Mild cases of asthma and allergy.
• Acid reflux syndrome.
• Hypercholesterolemia.
• Subjects with a past history of tics but tic free for \> 1 year.
• Subjects with past history of depression, anxiety disorder (including OCD) without current disorder for \> 6 months as ascertained through structured diagnostic interview and clinical exam.
• Subjects treated for anxiety disorders (including OCD), and depression who are on a stable medication regimen for at least three months, and who have a disorder specific CGI-severity score ≤ 3 (mildly ill) and who have a score on the Hamilton-Depression and Hamilton-anxiety rating scale below 15 (mild range) will be included in the study.
• Subjects receiving non-MAOI antidepressants (e.g., SSRI's, venlafaxine), benzodiazepines, on a stable regimen for \> 3 months for any of the conditions listed above.

You may not qualify if:

• Diagnosis of, or family history of Tourette's syndrome, or Autism.
• History of seizures.
• Subjects with history of tics in the past year.
• Subjects with a known recent history (within the past six (6) months) of illicit drug or alcohol dependence.
• Any clinically unstable psychiatric conditions including the following: bipolar disorder, acute psychosis, acute panic, acute OCD, acute mania, acute suicidality, acute substance use disorders (alcohol or drugs), acute OCD, sociopathy, criminality or delinquency.
• Subjects currently (within the past 4 weeks) receiving bupropion.
• Any metabolic, neurological, hepatic, renal, cardiovascular, hematological, opthalmic, or endocrine disease.
• Clinically significant abnormal baseline laboratory values, which include the following:
• Values larger than 20% above the upper range of the laboratory standard of a basic metabolic screen.
• Organic brain disorders.
• Mental impairment as evidenced by an I.Q. \<70 as determined by an abbreviated version of the Wechsler Adult Intelligence Scales (Wechsler Adult Intelligence Scales-Revised (WAIS-III) and the Wide Range Achievement Test (WRAT-III).
• Pregnancy or lactation.
• Glaucoma.
• Non English speaking subjects will not be allowed into the study for the following reasons: a) the assessment instruments are not available and have not been adequately standardized in other languages; b) our clinical trials facility is located in Cambridge and not in the MGH main campus without the availability of translators; and c) even if such translation services were to be available, the assessments in the English language conducted by English speaking clinicians and raters with English speaking subjects is already extremely time consuming lasting many hours making it unfeasible, unrealistic, and of dubious clinical validity to conduct them with a translator with non English speaking subjects; d) psychiatric questionnaires and evaluations are taxing and adding the complexity of a translator has the potential to make the patient experience even more exhausting.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.: collaborator

Study Sites (1)

Massachusetts General Hospital

Cambridge, Massachusetts, 02138, United States

Location

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

• Thomas Spencer, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 10, 2006
• First Posted: March 14, 2006
• Study Start: July 1, 2003
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: July 12, 2011

Record last verified: 2011-07

Locations

US (1)