A study of bitopertin (RO4917838) in combination with selective serotonin reuptake inhibitors in patients with obsessive-compulsive disorder
Clinicaltrials.gov identifier: NCT01674361
12/22/2014- This study is no longer recruiting participants.
12/16/2015- Data analysis and reporting procedures are in progress.
Several recent studies suggest a glutamate imbalance in some OCD patients. Medications that modulate glutamate, directly or indirectly, represent a potential new avenue to treat OCD symptoms. We have recently begun a Phase-II trial of bitopertin (F. Hoffmann-La Roche Ltd), a glutamate modulator with a novel mechanism of action: inhibition of glycine reuptake. We have proposed that inhibition of glycine reuptake may modulate glutamate transmission in ways that will be therapeutic in OCD; small studies with glycine itself and with the transport inhibitor sarcosine have yielded promising results. We are excited to study this new agent in patients with OCD and are hopeful that it will provide relief for some of those whose symptoms are refractory to standard treatment approaches.
The study will investigate the efficacy of adding bitopertin to a stable dose of a selective serotonin reuptake inhibitor (SSRI), such as fluoxetine (Prozac), sertraline (Zoloft), or escitalopram (Lexapro).
Yale is one of twelve sites across the country collaborating on this effort.
Riluzole augmentation in treatment-refractory OCD
Clinicaltrials.gov identifier: NCT00523718
*Update: This study has been completed and is no longer recruiting participants. Results have been published.
Several lines of evidence suggest that the neurotransmitter glutamate is out of balance in at least some cases of OCD. Medications that modulate glutamate in the brain may therefore represent a new avenue to treat OCD symptoms, and may be of use in patients whose symptoms do not respond well to established methods of treatment. Some years ago, the Yale OCD Research Clinic began investigating the glutamate-modulating drug riluzole (Rilutek®), which is FDA-approved for the treatment of the neurological disease amyotrophic lateral sclerosis. In early studies, without a control group, we found this medication to be helpful to a number of patients with severe, treatment-refractory OCD. In a follow-up study with another group of patients – still without a control group – we found that this benefit can persist for over a year after initial treatment. Another group of investigators, working at the National Institute of Health, has recently published preliminary evidence that riluzole may be of benefit in pediatric OCD.
If this is to be established as a viable treatment for refractory OCD, benefit to patients must be shown in a placebo-controlled study. We have recently begun such a study, and are seeking patients to participate in it. With this pilot controlled study, we hope to confirm our promising but preliminary early results and better establish whether or not riluzole has a role in the treatment of OCD after first-line medication has been tried.
This study is supported by a grant from the National Institute of Mental Health (R34MH083115)