FAAH Inhibitor Trial for Adults With Tourette Syndrome
- Registration Number
- NCT02134080
- Lead Sponsor
- Yale University
- Brief Summary
The purpose of this trial is to examine the safety, tolerability and feasibility in the use of a FAAH inhibitor for the treatment of adults with Tourette syndrome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
Inclusion Criteria
- Adult between 18-60 years of age
- Meet DSM IV criteria for the diagnosis of Tourette's syndrome
- Significant current tic symptoms: YGTSS total tic score greater than or equal to 22 at baseline
- On stable psychiatric medication regimen for a minimum of 4 weeks prior to beginning the trial.
- Accepted method of birth control
Exclusion Criteria
- Comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental disorder or intellectual disability (IQ<70).
- Current use of medications that have significant effects on the cannabinoid or dopamine systems. Subjects will be specifically excluded for recent use (within last 8 weeks) of antipsychotic medications, dopamine agonists or psychostimulants.
- Recent change (less than 4 weeks) in other medications that have potential effects on tic severity (such as alpha-2 agonists (guanfacine, clonidine or prazosin), SSRIs, clomipramine, naltrexone, lithium, anxiolytics, topiramate, baclofen etc.). Medication change is defined to include dose changes or medication discontinuation.
- Recent change in behavioral treatment for Tourette syndrome or comorbid conditions (i.e. OCD) within the last 4 weeks or initiation of behavioral therapy for tics within the last 12 weeks.
- Positive pregnancy test or drug screening test
- History of cannabis dependence
- Significant Medical Comorbidity
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo (sugar pill) will be administered orally at 4mg daily for four weeks. PF-04457845 PF-04457845 PF-04457845 will be administered orally at 4mg daily for four weeks.
- Primary Outcome Measures
Name Time Method Improvement in Tic Severity Evaluated each time subject seen over approximately 12 weeks Yale Global Tic Severity Scale (Total Tic Score)
- Secondary Outcome Measures
Name Time Method Improvement in Obsessive Compulsive Disorder (OCD) Severity Evaluated every two weeks over the course of approximately 12 weeks Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
Self-Report of Tic Severity Evaluated each time subject seen over approximately 12 weeks Tourette Syndrome Symptom List (TSSL)
Video-Tape Ratings of Tic Severity Evaluated every two weeks over the course of approximately 12 weeks Modified Rush Video Rating Scale
ADHD Severity Evaluated every two weeks over the course of approximately 12 weeks Connors Adult Attention Deficit Hyperactivity Rating Scale
Improvement of Premonitory Urges Evaluated each time subject seen over approximately 12 Weeks Premonitory Urge for Tics Scale (PUTS)
Depression Severity Evaluated every two weeks over the course of approximately 12 weeks Hamilton Rating Scale for Depression
Anxiety Severity Evaluated every two weeks over the course of approximately 12 weeks Hamilton Rating Scale for Anxiety
Overall improvement Evaluated each time subject seen over approximately 12 Weeks Clinical Global Improvement Scale
Number of Adverse Events Evaluated each time subject seen over approximately 12 Weeks Adverse Events Rating Scale
Trial Locations
- Locations (1)
Connecticut Mental Health Center
🇺🇸New Haven, Connecticut, United States