Study to Evaluate the Efficacy and Quality of Life of Long-Acting Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Long-Acting Methylphenidate
Intervention description: Long-Acting Methylphenidate within the range of 18, 36, 54 and 76 milligram will be orally administered once daily up to Day 56.
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Attention Deficit Hyperactivity Disorder; Methylphenidate; Concerta; CONQoL

Summary:

      The purpose of this study is to evaluate the efficacy, safety and to assess the impact of the
      treatment on quality of life of long-acting methylphenidate in adult participants with
      Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a clinical condition beginning in
      childhood and is characterized by inadequate levels of attention, hyperactivity and
      impulsiveness.
    

Eligibility criteria:

        Inclusion Criteria

          -  Diagnosis of Attention Deficient Hyperactivity Disorder (ADHD) according to the
             Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV),
             obtained via interview with an adapted version of the Kiddie-Schedule of Affective
             Disorders and Schizophrenia-Epidemiologic Version (K-SADS E) module for ADHD

          -  Described chronic course of ADHD symptomatology from childhood to adulthood, with some
             symptoms present before age 7 years, which continue to meet DSM-IV criteria at the
             time of assessment. ADHD is not diagnosed if the symptoms are better accounted for by
             another psychiatric disorder [e.g. mood disorder (especially bipolar disorder),
             anxiety disorder, psychotic disorder, personality disorder]

          -  Clinical Global Impression-Severity (CGI-Severity) baseline score greater than or
             equal to (>=) 4 (at least moderate severity)

          -  Female participants must be postmenopausal (after the time in life when a woman stops
             having a menstrual period) for at least 1year, surgically sterile, or practicing an
             effective method of birth control (e.g., prescription oral contraceptives[compounds,
             usually hormonal, taken orally in order to block ovulation and prevent the occurrence
             of pregnancy], contraceptive injections [chemical substances that prevent or reduce
             the probability of pregnancy], intrauterine device [contraceptive devices placed high
             in the uterine fundus], double-barrier method, contraceptive patch, male partner
             sterilization) before entry and throughout the study; have a negative urine pregnancy
             test at baseline

          -  Participant agrees to take only the supplied study drug as treatment for ADHD during
             the study

        Exclusion Criteria

          -  Participant having allergy or hypersensitivity to methylphenidate

          -  Participants who are non-responder to methylphenidate in adequate doses (i.e., 0.8 -
             1.0 milligram per kilogram [mg/kg])

          -  Participant treated with any methylphenidate or amphetamine containing medication
             within 4 weeks of the screening visit

          -  Participant having Hamilton's Depression Scale, suicide item higher than 2

          -  Participant having any psychiatric condition including the following, but not limited
             to: acute mood disorder (disorders that have a disturbance in mood as their main
             feature), schizophrenia (a mixed psychiatric disorder relating to a complex psychotic
             state that has features of both schizophrenia and a mood disorder such as bipolar
             disorder), bipolar disorder I (disorder marked by severe mood swings (manic or major
             depressive episodes) and a tendency to remission [when a medical problem gets better
             or goes away at least for a while] and recurrence [happen again]), obsessive
             compulsive disorder (OCD) (an anxiety disorder characterized by recurrent, persistent
             obsessions or compulsions, anti-social personality disorder ( personality disorder
             whose essential feature is a pervasive pattern of disregard for, and violation of, the
             rights of others that begins in childhood or early adolescence and continues into
             adulthood)