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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
5
PF-04457845 will be administered orally at 4mg daily for four weeks.
Placebo will be administered orally at 4mg daily for four weeks.
Connecticut Mental Health Center
New Haven, Connecticut, United States
Improvement in Tic Severity
Yale Global Tic Severity Scale (Total Tic Score)
Time frame: Evaluated each time subject seen over approximately 12 weeks
Improvement of Premonitory Urges
Premonitory Urge for Tics Scale (PUTS)
Time frame: Evaluated each time subject seen over approximately 12 Weeks
Improvement in Obsessive Compulsive Disorder (OCD) Severity
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
Time frame: Evaluated every two weeks over the course of approximately 12 weeks
Self-Report of Tic Severity
Tourette Syndrome Symptom List (TSSL)
Time frame: Evaluated each time subject seen over approximately 12 weeks
Video-Tape Ratings of Tic Severity
Modified Rush Video Rating Scale
Time frame: Evaluated every two weeks over the course of approximately 12 weeks
ADHD Severity
Connors Adult Attention Deficit Hyperactivity Rating Scale
Time frame: Evaluated every two weeks over the course of approximately 12 weeks
Depression Severity
Hamilton Rating Scale for Depression
Time frame: Evaluated every two weeks over the course of approximately 12 weeks
Anxiety Severity
Hamilton Rating Scale for Anxiety
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Time frame: Evaluated every two weeks over the course of approximately 12 weeks
Overall improvement
Clinical Global Improvement Scale
Time frame: Evaluated each time subject seen over approximately 12 Weeks
Number of Adverse Events
Adverse Events Rating Scale
Time frame: Evaluated each time subject seen over approximately 12 Weeks