study to evaluate the efficacy and quality of life of long-acting methylphenidate in adults with attention deficit hyperactivity disorder (adhd)

Conditions: Attention Deficit Hyperactivity Disorder

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.

this is an open-label (all people know the identity of the intervention), multi-center (when more than one hospital or medical school team work on a medical research study), single arm study of multiple doses of long-acting methylphenidate in participants with adhd. the study will consist of 2 phases; a screening phase and a treatment phase. the duration of participation in the study for an individual participant will be up to 12 weeks. participants will be given 18 milligram (mg) of long-acting methylphenidate daily in the morning and titrated up (slow increase in drug dosage guided by participant's responses) to 36 mg per day (mg/day) on day 8. depending on response, tolerability and clinician's judgment, the dose could be escalated to the next dose level of 54 mg/day on day 28 to a maximum of 72 mg/day on day 56, until each participant achieved optimal dose. participant's safety will be monitored throughout the study.

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)

Keywords: attention deficit hyperactivity disorder methylphenidate concerta conqol