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 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT00634556
Eligibility Criteria:
Inclusion Criteria:
* Age 18-55.
* Tic subjects must meet DSM-IV-TR criteria for a chronic tic disorder.
* Controls are matched for age (within 4 years), sex, handedness (right-handed, non-right-handed), and education (within 2 years), and if possible for race and ethnicity
Exclusion Criteria:
* Inability to give competent informed consent.
* Lactation, pregnancy or possibility of pregnancy.
* Contraindication to MRI (pacemaker; nontrivial metallic foreign bodies; significant claustrophobia).
* Contraindication to levodopa or carbidopa (known allergy).
* Significant neurological disease (not counting the tic disorder).
* Current renal, cardiac or hepatic disease that would make study participation less safe.
* Head injury with loss of consciousness for more than 5 minutes or with neurological sequelae.
* Lifetime history of serious lifetime psychopathology or substance abuse. (Specific exclusions are: lifetime diagnosis of mental retardation, autism, psychosis, mania, somatization disorder, panic disorder, social phobia \[excludes symptoms present only when treated with a neuroleptic\], anorexia nervosa or bulimia, drug or alcohol dependence, antisocial personality disorder, or dementia, or current major depression.)
* Depot neuroleptics in the past 6 months.
* Other antipsychotics within the past 2 weeks.
* Behavioral therapy for Tics of OCD sx in the past 2 weeks.
* For one half of the subjects in each diagnostic group: any brain-active medications within the past 2 weeks. For the remaining subjects: neuroactive medications in the past 2 weeks other than SSRIs, alpha-2 agonists, norepinephrine reuptake inhibitors, or clonazepam.
* Additional exclusions for controls: No history of tic disorder, OCD or ADHD. If under age 25, no first-degree relative with a tic disorder. No exposure to neuroleptics in the past year and none ever for a period exceeding a week.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00634556
Study Brief:
Protocol Section:
NCT00634556