Status:
COMPLETED
A Double-Blind Comparison of Concerta and Placebo in Adults With Attention Deficit Hyperactivity Disorder
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Conditions:
ADHD
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
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 (...
Detailed Description
Concerta was specially developed to replace three-times-a-day IR methylphenidate, making it an ideal option for patients with ADHD. Moreover, the once-a-day administration of Concerta secures a steady...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
297 Patients enrolled
Trial Details
Trial ID
NCT00181571
Start Date
June 1 2003
End Date
August 1 2007
Last Update
June 27 2013
Active Locations (1)
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1
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138