A Study to Test the Safety and Efficacy of MK0249 in Patients With ADHD (0249-018)(COMPLETED)

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the safety and efficacy of an investigational treatment for Attention Deficit Hyperactivity Disorder (ADHD) when compared to placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

• Patient is between 18 and 55 years of age (inclusive)

• Patient is an adult with a current DSM-IV diagnosis of ADHD of inattentive or combined subtype, as assessed via a structured interview using the ACDS and AISRS

• Females of child-bearing potential must use acceptable methods of birth control during the study and for 1 month post-therapy

Exclusion Criteria:

• Patient has a history of a neurological disorder resulting in ongoing impairment

• Patient has a lifetime history of a psychotic disorder, bipolar disorder, or post-traumatic stress disorder

• Patient has evidence of ongoing depression

• Patient is sensitive or allergic to methylphenidate

• Patient has glaucoma

• Patient has a previous history of narrowing or blockage of the GI tract

• Patient has a history of a sleep disorder (e.g., insomnia, sleep apnea, nightmares, or night terrors) within 6 months prior to screening

• Patient has a history of a cardiovascular disorder within 6 months prior to screening

• Patient has moderate or severe persistent asthma

• Patient has a history of substance abuse or dependence not in sustained full remission for at least one year according to DSM-IV

• Patient has taken part in a research study within the past 30 days of signing informed consent