A Study to Evaluate Effectiveness and Safety of Prolonged Release OROS Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit/ Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy of 2 fixed dosages of Prolonged Release
      (PR) OROS methylphenidate (54 and 72 mg/day) compared with placebo in adult patients with
      attention deficit/hyperactivity disorder (ADHD).
    

Detailed description: 
      The primary objective of this study is to evaluate the efficacy of 2 fixed dosages of
      Prolonged Release (PR) OROS methylphenidate (54 and 72 mg/day) compared with placebo in adult
      patients with attention deficit/hyperactivity disorder (ADHD). The primary efficacy criterion
      will be the change in the sum of the inattention and hyperactivity/impulsivity subscale
      scores of the investigator-rated Conners' Adult ADHD Rating Scale (CAARS), from start of
      treatment to the end of the double-blind treatment. Hypothesis of the primary objective
      states that either PR OROS methylphenidate dose is more effective than placebo after 13 weeks
      of treatment in adult patients with ADHD. This is a multicentre, double-blind, randomized,
      placebo-controlled, parallel group, dose-response study. Patients will be randomized into one
      of 3 treatment groups to receive oral dosages of PR OROS methylphenidate 54 or 72 mg, or
      placebo once daily. The study includes a treatment period of 13 weeks. Patients will be
      titrated from a starting dose of 36 mg/day for 7 days, to 54 or 72 mg/day at Day 8, after
      which treatment will be administered for 12 weeks. The study will include a screening period
      of up to 2 weeks, during which current therapy, not allowed during the study can be tapered
      down and discontinued (with the exception of fluoxetine or MAO (monoamine oxidase) inhibitors
      for which a maximum screening period of 4 weeks will be allowed). A post-study visit for
      collection of additional efficacy and safety data will be scheduled for one week after a
      patient's final dose of study drug. Adults with a diagnosis of ADHD according to DSM-IV
      criteria with some symptoms before age 7 years that continue to meet these criteria at the
      time of assessment will be enrolled in this study. ADHD is not diagnosed if the symptoms are
      better accounted for by another psychiatric disorder (e.g. mood disorder, anxiety disorder,
      psychotic disorder, personality disorder). The patient (and if possible, informant) must also
      describe a chronic course of ADHD symptomatology from childhood to adulthood. The description
      of this chronic course can be patient-based and previous documented diagnosis and/or
      treatment is not required. Approximately 300 patients (100 in each randomized treatment
      group) will participate in this study. The primary efficacy criterion will be the change in
      the sum of the inattention and hyperactivity/impulsivity subscale scores of the
      investigator-rated CAARS from baseline to the end of treatment (end of 13 weeks or last
      post-baseline assessment). This variable will be compared between each dosage group and
      placebo using an ANCOVA model. Other end points will include changes from baseline to the end
      of the treatment in the CAARS subscales and assessment of the clinical global impression -
      global change subscale (CGI-C). Onset of therapeutic effect and responder rate will also be
      determined. In addition, morning / evening (8 pm) CAARS-S:S assessments will be performed at
      baseline and on Days 34, 35, 90 and 91. Safety evaluations will include monitoring of adverse
      events (AEs), clinical laboratory tests (hematology; biochemistry), pregnancy testing, vital
      signs (supine and standing blood pressure, pulse) and weight, ECG. Patients will be
      randomized to receive PR OROS methylphenidate 54 or 72 mg, or placebo once daily. Study drug
      will be administered daily in the morning for up to 13 weeks. Since there is no food effect
      with methylphenidate, drug administration can be under fed or fasted conditions. Patients
      will start at a dosage of 36 mg. At Week 2, patients will receive 54 or 72 mg PR OROS
      methylphenidate for 12 weeks.
    

Intervention name(s): prolonged release (PR) OROS methylphenidate 54 mg; prolonged release (PR) OROS methylphenidate 72 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 18+36mg once daily for 13 weeks; 2x36mg once daily for 13 weeks; 2xplacebo once daily for 13 weeks
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adult; ADHD; Concerta