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

Completed · Phase 4 · Has a placebo group

Conditions studied: ADHD

In brief

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.

Key facts

Study ID

NCT00181571

Run by

Massachusetts General Hospital

People needed

297

Starts

2003-06-01

Expected to finish

2007-08-01

Last updated by the study team

2013-06-27

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

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.
• Exclusionary blood pressure > 140 (systolic) and 90 (diastolic).
• Exclusionary ECG parameters: QTC > 460 msec, QRS > 120 msec, and PR > 200 msec. Subjects having ECG evidence of ischemia or arrhythmia as reviewed by an independent cardiologist.
• 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

Where it is running

• Massachusetts General Hospital — Cambridge, Massachusetts, United States

Full record on ClinicalTrials.gov

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