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| Sponsor: | Yale University |
|---|---|
| Information provided by (Responsible Party): | Christopher Pittenger, Yale University |
| ClinicalTrials.gov Identifier: | NCT00523718 |
Purpose
Obsessive-compulsive disorder (OCD) affects 2-3% of the population and leads to a great deal of suffering. Many patients benefit from established treatments, the mainstay of which are cognitive behavioral therapy and a group of antidepressant medications known as serotonin reuptake inhibitors. However, 20-30% of patients get minimal benefit from these established therapeutic strategies. New avenues of treatment are urgently needed.
Existing medications for obsessive-compulsive disorder affect the neurotransmitters serotonin or dopamine; but increasing evidence suggests that functional disruptions of a different neurotransmitter, glutamate, may contribute to some cases of OCD. The investigators are therefore interested in using medications that target glutamate as novel treatment options for those OCD patients who do not benefit from established treatments.
One such medication is the drug riluzole, which is FDA approved for amyotrophic lateral sclerosis (ALS), or Lou Gehrig's disease, but may be of benefit to patients with psychiatric disorders due to its ability to moderate excessive glutamate. In preliminary studies, in which the investigators treated patients with riluzole (in addition to their established pharmacological regimen) in an open-label fashion (that is, without a placebo-treated control group), the investigators have found about 40-50% of patients to substantially improve over 2-3 months.
While immensely promising, these preliminary studies do not prove riluzole is truly a new beneficial medication for the treatment of OCD; a more rigorous placebo-controlled trial is needed for that purpose. The investigators are therefore now recruiting patients to participate in a double-blind, placebo-controlled trial of riluzole, added to whatever other OCD medications they are taking.
| Condition | Intervention | Phase |
|---|---|---|
|
Obsessive-compulsive Disorder Ocd |
Drug: riluzole Drug: placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-blind Study of Riluzole Augmentation in Serotonin Reuptake Inhibitor-refractory Obsessive-compulsive Disorder and Depression |
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: riluzole
Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment
|
Drug: riluzole
50 mg PO bid, 12 weeks
Other Name: Rilutek (Sanofi-Aventis)
|
|
Placebo Comparator: placebo
Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.
|
Drug: placebo
placebo, 1 capsule PO bid, 12 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Eileen Billingslea, MA | 203-974-7768 | eileen.billingslea@yale.edu |
| Contact: Suzanne Wasylink, BC-RN | 203-974-7523 | suzanne.wasylink@yale.edu |
| United States, Connecticut | |
| Yale OCD Research Clinic | Recruiting |
| New Haven, Connecticut, United States, 06508 | |
| Contact: Suzane Wasylink, RN 203-974-7523 | |
| Principal Investigator: Christoper J Pittenger, MD, Ph.D. | |
| Sub-Investigator: Gerard Sanacora, MD, Ph.D. | |
| Sub-Investigator: Vladimir Coric, MD | |
| Principal Investigator: | Christopher J Pittenger, MD, Ph.D. | Yale University |
More Information
| Responsible Party: | Christopher Pittenger, Principal Investigator, Yale University |
| ClinicalTrials.gov Identifier: | NCT00523718 History of Changes |
| Other Study ID Numbers: | YOCD-1 |
| Study First Received: | August 29, 2007 |
| Last Updated: | January 25, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
obsessive-compulsive disorder OCD glutamate |
riluzole augmentation treatment |
|
Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders Riluzole Serotonin Uptake Inhibitors Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Physiological Effects of Drugs Neuroprotective Agents Protective Agents Central Nervous System Agents Therapeutic Uses Anticonvulsants Neurotransmitter Uptake Inhibitors Serotonin Agents |