Summary:
A multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of low-dose ondansetron for adjunctive therapy in adult patients with obsessive compulsive disorder who have not adequately responded to treatment with a selective serotonin reuptake inhibitor.
Qualified Participants Must:
• Be 18 years of age or older
•
Be able to understand the study and provide informed consent
•
Be fluent in English
•
Be willing and able to comply with the requirements of the protocol and follow directions from the clinic staff
•
Have a body mass index (BMI) ≥18 and ≤ 40 kg/m2 (wearing indoor clothing without shoes)
•
For female patients only: Female patients will be included if they are post-menopausal or sterilized, or if they are of childbearing potential, they are not breastfeeding, their pregnancy test is negative, they have no intention of becoming pregnant during the course of the study, and are using adequate contraceptive drugs or devices. Medically acceptable methods of contraception that may be used by the patient and/or her partner are: oral contraceptives, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization or abstinence. Females using oral contraception must have started using the medication at least 8 weeks prior to screening. Surgical sterilization must have occurred at least 6 weeks prior to screening
•
Have documented diagnosis of OCD as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria
•
Have documented history of stable and current regimen of one of the following four SSRIs for at least 6 weeks prior to screening at the minimum daily dosage listed: fluvoxamine (Luvox®) 200 mg, fluoxetine (Prozac®) 40 mg, paroxetine (Paxil®) 40 mg, sertraline (Zoloft®) 100 mg, Y-BOCS score of ≥ 24, HAM-D score of < 20
•
Additional inclusion criteria for randomization to double-blind treatment period: Patients must meet the following criteria at Day -1 to qualify for randomization: Demonstrated failure to adequately respond to SSRI treatment, defined by the following
Qualified Participants May Receive:
Free physical, free medication, free treatment for OCD and will be compensated for their time and travel.