Potential Adjunctive Treatment for OCD Patients who do not Adequately Respond to Treatment with a Serotonin Reuptake Inhibitor
Need more help for your OCD? Many people with OCD experience only a partial response to currently available medications.
Montefiore Medical Center and multiple sites across the U.S. are seeking volunteers to participate in a clinical trial evaluating the effectiveness of low-dose ondansetron augmentation for the treatment of OCD in patients who have not adequately responded to their current SRI therapy after at least 12 weeks of stable treatment.
Eligible participants will be randomly assigned to receive ondansetron 0.5 mg, ondansetron 0.75 mg, or placebo, twice daily. Participants will continue the current SRI treatment and receive 12 weeks of augmentation. Participants completing the 12-week treatment may have the opportunity to continue treatment for up to one additional year. Treatment is provided at no cost.
Participants must have a DSM-IV-TR diagnosis of OCD as their primary disorder who have been on a stable treatment regimen of clomipramine, fluvoxamine, fluoxetine, paroxetine or sertraline for at least 6 weeks may be eligible for this study. Six additional weeks of stable SRI treatment, without adequate clinical response, will be required prior to randomization, after which the participant will receive SRI plus study drug, for a total of 12 more weeks.
Exclusion criteria include, but are not restricted to the following:
· Failure to respond to more than 2 SRI treatments prior to current SRI
· Hoarding as primary OCD symptom
· Current or past medical history of schizophrenia or other psychotic disorders, schizotypal personality disorder, bipolar disorder, Tourette syndrome, autism or autistic spectrum disorders, eating disorders, PTSD
· Requiring active behavioral therapy
· History of drug addiction or drug, alcohol or other substance abuse within the past 12 months
· Currently taking, or having taken within the previous 8 weeks, any of the following: other SRIs, antipsychotic drugs, lithium, benzodiazepines or other anxiolytics, carbamazepine, oxcarbazepine, phenytoin, or other anti-depressants (including St. John’s Wort)
· Likely to use triptans at any time during the study
· Believed to have suicidal or homicidal risk