A Study to Evaluate the Efficacy and Safety of Two Doses of PF-03654746 in Adults With Attention Deficit Hyperactivity Disorder (ADHD).

Completed · Phase 2 · Has a placebo group

Conditions studied: Attention Deficit Hyperactivity Disorder

In brief

The purpose of this study is to determine whether PF-03654746 is effective in the treatment of Adult Attention Deficit Hyperactivity Disorder (ADHD). This will be a randomized, double-blind, crossover study in which adults with ADHD will receive 3 weeks of treatment with PF-03654746, either a low dose (1 mg), or flexible dose (0.50 mg titrated up to 2 mg), and 3 weeks of placebo. A washout period will separate the 2 treatment periods. Participants will be required to washout of prior ADHD medication before entering the study. Participants will be required to come to the site for 10 visits over approximately a 10-week period.

Key facts

Study ID

NCT00531752

Run by

Pfizer

People needed

66

Starts

2007-12-01

Expected to finish

2008-09-01

Last updated by the study team

2016-02-19

Who can join

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

You may qualify if…

• Subjects with a diagnosis of Attention Deficit Hyperactivity Disorder, based on clinical assessment and interview.
• Male and female outpatients. Subjects with a diagnosis of Attention Deficit Hyperactivity Disorder, based on clinical assessment and interview.
• Female subjects must be of non-childbearing potential.

You may not qualify if…

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular (including hypertension), hepatic, neurologic, or allergic disease.
• Current or lifetime history of psychosis or bipolar disorder; any current anxiety disorder (with the exception of social or specific phobia), or substance abuse or dependence in the past 6 months.
• Current episode of Major Depression or episode within the last 6 months.

Where it is running

• Bay Area Research Institute — Lafayette, California, United States
• Pharmacology Research Institute — Los Alamitos, California, United States
• Pharmacology Research Institute — Newport Beach, California, United States
• The University of Illinois at Chicago, Institute for Juvenile Research — Chicago, Illinois, United States
• Massachusetts General Hospital, ADHD Program — Cambridge, Massachusetts, United States
• New York University School of Medicine — New York, New York, United States
• NeuroScience, Inc — Herndon, Virginia, United States

Full record on ClinicalTrials.gov

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