Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-24 @ 10:08 PM
NCT ID:
NCT00783835
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00783835
Study Brief:
Protocol Section:
NCT00783835