A Double-Blind Comparison of Concerta and Placebo in Adults With Attention Deficit Hyperactivity Disorder

NCT00181571 | Completed Phase 4 DMC

• 1 other identifier: 2003-p-000037
• Study Type: interventional
• Target: 297
• Locations: 1 country
• Sites: 1

Brief Summary

This is a double-blind, placebo-controlled study using daily doses of up to 1.3 mg/kg/day of Concerta in the treatment of adults with the DSM-IV diagnosis of attention deficit hyperactivity disorder (ADHD) (childhood onset). We hypothesize ADHD symptomatology in adults with DSM-IV ADHD will be responsive to Concerta treatment and Concerta-associated response of ADHD symptomatology in adults will be sustained over time.

Conditions

ADHD

Keywords

ADHD; Adults; Concerta; Double-Blind

Outcome Measures

Primary Outcomes (1)

• Symptom reduction using ADHD-Clinical Global Impression and ADHD Symptom Checklist Severity scale administered at each visit.

  34 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Concerta

Drug: methylphenidate HCl (Concerta)

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

methylphenidate HCl (Concerta) DRUG

up to a maximum dose of 1.3 mg Concerta/kg/day, and not more than 144 mg/day for any subject regardless of weight.

Also known as: Concerta

1

Placebo DRUG

up to a maximum dose of 1.3 mg Placebo /kg/day, and not more than 144 mg/day for any subject regardless of weight.

2

Eligibility Criteria

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

You may qualify if:

• Male and female outpatients older than 18 and younger than 55 years of age.
• Subjects with the diagnosis of attention deficit hyperactivity disorder (ADHD), by DSM-IV, as manifested in clinical evaluation and confirmed by structured interview.
• ADHD Symptom Checklist score \> 24.
• Patients with past history of depression, bipolar disorder, anxiety disorder (including OCD) without current disorder for \> 3 months as ascertained through structured diagnostic interview and clinical exam.
• Subjects treated for anxiety disorders 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 scales below 15 (mild range).
• Subjects with a past history of tics but tic free for \> 1 year.
• Subjects with past history of substance use disorders but substance free for \> 6 months.
• Subjects receiving non-MAOI antidepressants (e.g., SSRI's, bupropion, venlafaxine) or benzodiazepines who have been on a stable regimen for \> 3 months for any of the conditions listed above.

You may not qualify if:

• Any clinically unstable psychiatric conditions including the following: acute psychosis, acute panic, acute OCD, acute mania, acute suicidality, bipolar disorder, acute substance use disorders (alcohol or drugs, sociopathy, criminality, or delinquency.
• Any metabolic, neurological, hepatic, renal, cardiovascular, hematological, opthalmic, or endocrine disease.
• 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.
• Mental retardation (IQ \<75).
• Organic brain disorders.
• Seizures or tics in the last year.
• Pregnant or nursing females.
• Subjects with current adequate treatment for ADHD or a history of a previous adequate trial of Concerta.
• Non-English speaking subjects will not be allowed into the study for the following reasons:
• the assessment instruments are unavailable and have not been adequately standardized in other languages;
• our clinical trials facility is located in Cambridge and not at the MGH main campus; thus translators are unavailable;
• even if such translation services were available, the assessments in the English language conducted by English-speaking clinicians and raters with English-speaking subjects are 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;
• 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

Related Publications (1)

• Biederman J, Mick E, Fried R, Wilner N, Spencer TJ, Faraone SV. Are stimulants effective in the treatment of executive function deficits? Results from a randomized double blind study of OROS-methylphenidate in adults with ADHD. Eur Neuropsychopharmacol. 2011 Jul;21(7):508-15. doi: 10.1016/j.euroneuro.2010.11.005. Epub 2011 Mar 9.

  PMID: 21303732 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

• Joseph Biederman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: June 1, 2003
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: June 27, 2013

Record last verified: 2013-06

Locations

US (1)