OCD (Obsessive Compulsive Disorder) - Oceanside CA

Summary:

Study Synopsis: Randomized, Double Bind, of Troriluzole for Obsessive Compulsive Disorder 

Study Drug: 2 arms- Placebo or Troriluzole (280mg QD, after 2 weeks = 200mg QD) taken in the morning with food but can be changed to evenings per Doctor’s permission.  

Study Length: total treatment period is 10 weeks, with a 42-day screen and 14 day follow up.  

Compensation: $100 after each completed appointment

Key Points: 

• Subjects can roll over into extension study for 48 weeks after 

Inclusionary: 

• 18-65 years old 

• DSM5 Dx of OCD ≥ 1 year 

• Currently on an SSRI at least 8 weeks at screening and 12 weeks at baseline 

• Currently experiencing non-response or inadequate response to their current SOC medication 

• Stable dose of other medications for at least 12 weeks prior to screen 

• CGI-S score of ≥ 4 at screening and baseline, “pass” the SAFER interview performed by CTNI, and a minimum of 6 years of education. 

Exclusionary: 

• No history of psychosurgery, substance abuse, stroke/seizure 

• No history of liver disease, heart, gastrointestinal, hematologic, or diabetes 

• No BMI >40 kg/m2 

• No vitamin B12/folate deficiency 

• No positive cannabis or drug test 

• No other psychological diagnosis than OCD 

• Total BABS score >17  

• No active MDD or anxiety 

• No suicidal behavior in the last 12 months 

Allowed ConMeds: 

- Zolpidem tartrate (Ambien): up to 10 mg at bedtime (HS) as needed (prn);  

-  Zolpidem tartrate extended-release (Ambien CR): up to 12.5 mg at HS prn;  

- Zaleplon (Sonata): up to 20 mg at HS prn  

- Eszopiclone (Lunesta): up to 3 mg at HS prn.  

- Oral contraceptives which contain ethinyl estradiol 

- Lorazepam (up to 1 mg/day) or equivalent benzodiazepine for sleep and anxiety is allowed if used at a stable dose for at least 3 months prior to screening 

Disallowed ConMeds up to 4 weeks prior: 

-stimulants, neuroleptics, mood stabilizer and glutamate agents (e.g. gabapentin, pregabalin, topiramate, lamotrigine, N- acetylcysteine, ketamine, memantine, sodium 

Disallowed ConMeds minimum 5 half-lives prior: 

- Strong to moderate CYP1A2 inhibitors like Fluvoxamine 

- Strong to moderate CYP1A2 inducers  

- Hepatotoxic drugs (e.g., allopurinol, methyldopa, sulfaszalzine)  

Qualified Participants May Receive:

- Compensation: $100 after each completed appointment.

- Placebo or Troriluzole (280mg QD, after 2 weeks = 200mg QD) in combination with current ADT.

-Travel assistance if participants need a ride.