Status:
COMPLETED
Dopaminergic Effects on Cortical Function in Tourette's (Levodopa Protocol)
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Tourette Syndrome
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Dr. Kevin J. Black at Washington University is conducting a study to learn whether we can use MRI scans to test dopamine function in the brain and to determine whether the brain performs memory tasks ...
Detailed Description
Clinical observations suggest that in TS there is abnormal function in the brain's motor system that can be modified by manipulating dopamine. My colleagues and I have hypothesized that nonmotor brain...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00634556
Start Date
February 1 2006
End Date
October 1 2010
Last Update
February 12 2018
Active Locations (1)
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1
Washington Universisty School of Medicine,
St Louis, Missouri, United States, 63110