Study to Evaluate the Efficacy and Quality of Life of Long-Acting Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Cilag Farmaceutica Ltda.
• Treatments: Methylphenidate

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)