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:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 12:56 AM
NCT ID:
NCT05361993
Eligibility Criteria:
Inclusion Criteria:
* Meet the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders(Fifth Edition,DSM-5) for chronic tic disorder or Tourette syndrome（TS）;
* Ethnic group is Han nationality;
* Aged 8 \~ 16 years old;
* otal IQ of Wechsler Intelligence Scale for Children ≥ 80 points for subjects;
* Symptom severity score in Yale Global Severity Scale (YGTSS), TS patients \> 13, CTD \> 9;
* Did not receive any drug (including traditional Chinese medicine) treatment 4 weeks before enrollment;
* Obtain written informed consent from children and guardians
Exclusion Criteria:
* Epilepsy, cardiovascular disease
* Patients with schizophrenia, mental retardation, autism spectrum disorder, bipolar disorder and major depression who meet the DSM-5 diagnostic criteria;
* Receiving systematic traditional Chinese medicine treatment one month before enrollment or currently;
* Receiving systematic psychotherapy one month before enrollment or currently;
* Receive systematic physical therapy one month before enrollment or currently
* Those who cannot follow the doctor's advice or refuse to cooperate;
* Those with obvious abnormal laboratory test results (AST or ALT ≥ 2 times of the upper limit of normal value; bun ≥ 1.5 times of the upper limit of normal value; Cr ≥ 1.2 times of the upper limit of normal value);
* Prolongation of QTc interval (QTc ≥ 450 ms in men or ≥ 470 MS in women);
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
16 Years
Study:
NCT05361993
Study Brief:
Protocol Section:
NCT05361993