A Study to Test the Safety and Efficacy of MK0249 in Patients With ADHD (0249-018)(COMPLETED)
Condition: Attention-Deficit/Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: MK0249; Concerta (methylphenidate); Placebo
Intervention description: MK-0249, 10 mg per day was taken orally daily. If patients were unable to tolerate 10 mg per day, they were allowed to titrate down to 5 mg per day.; Titration of Concerta began with two 18-mg capsules (36 mg) for 3 consecutive days, followed by three 18-mg capsules (54 mg) for another 3 consecutive days, ending with four 18-mg capsules (72 mg) for the remainder of the treatment period. If patients were unable to tolerate 72 mg per day, they were allowed to titrate down to 54 mg per day. Concerta was taken orally once daily.; For 4 of the 6 treatment sequences, patients had one 4-week treatment period with placebo of MK-0249 (tablets) and placebo of Concerta (capsules). For patients assigned to active treatments of MK-0249 or Concerta, in order to preserve the blind, placebo of the non-active component was provided, ie, if MK was assigned (tablets), then placebo of Concerta (capsules) was also provided. Each patient was to dose with tablets and capsules, either active or placebo. Placebo was taken orally once daily.
Intervention MeSH terms: Methylphenidate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

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.
    

Eligibility 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