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 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT01065259
Eligibility Criteria:
Inclusion Criteria:
* Age between 6 to 16 years old. Body weight between 20 to 60 kg
* Meet ADHD criteria in tne Diagnostic and Statistic Manual of Mental Disorders, fourth edition (DSM-IV) through questionaire and interview
* Intelligence quotient (IQ) \>= 70
* Currently unmedicated or effectively medicated with immediately released methylphenidate (The maximum dosage no more than 60mg/d)
* The patient and the parent express their will to comply with the follow up including the clinical interview and all the test
* The parent or the guardian sign the written consent
* Can swallow the capsule
Exclusion Criteria:
* Have administered immediate release methylphenidate, OROS MPH or atomoxetine, but ADHD symptoms not improved.
* Bipolar I or II disorder, psychosis, or pervasive developmental disorder.
* Meet the DSM-IV anxiety disorder.
* Any seizure disorder (except for febrile convulsion) or electroencephalogram (EEG) abnormal associated with epilepsy, or currently taking anti-convulsion drugs.
* Depression disorder, tend to commit suicide, or comorbid depression symptoms which need immediate treatment.
* Tics disorder, or Tourette's syndrom（DSM-IV 307.23）, or family history of tics disorder.
* Narrow-angle glaucoma
* cardiovascular diseases, or any diseases may be deteriorated when the pulse or the blood pressure increased, including hypertension or those taking anti-hypertension drugs.
* Diseases significantly enhance the sympathetic nervous system activity, or taking sympathomimetic drug every day.
* Allergic to methylphenidate or atomoxetine, or serious allergic reaction to more than one drugs or adverse event to multiple drugs before.
* Serious gastrointestinal stenosis
* History of alcohol, drug or other substance abuse
* Those using unprescribed potential abuse drugs in screening.
* In the process of the trial, the patient need to take other psychotropic drug other than the experimental drugs, including health food with central nervous system (CNS) activity (e.g. melatonin).
* Might begin any structure psychological therapy addressed for ADHD in the process of the trial
* Have used other psychotropic drugs in the past 30 days, including monoamine oxidase inhibitor.
* Are participating other clinical trial.
* Have difficulty in following up in 8 weeks.
* Relatives of the investigator.
* Employee of Xi-an Jensen or Eli lilly company.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
16 Years
Study:
NCT01065259
Study Brief:
Protocol Section:
NCT01065259