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| Sponsor: | Yale University |
|---|---|
| Information provided by: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00539513 |
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 researchers 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 N-Acetylcysteine, whose glutamatergic antagonistic properties may be effective in reducing the glutamatergic hyperactivity that is thought to contribute to the pathophysiology of OCD and major depressive disorder (MDD).
Riluzole, which is FDA approved for amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease) is also a glutamatergic agent. There is evidence that riluzole possesses anti-depressant, anti-obsessional, and anti-anxiety properties.
The modulation of glutamatergic activity is a promising new approach to the treatment of mood disorders. The researchers are therefore now recruiting patients to participate in a double-blind, placebo-controlled trial of N-Acetylcysteine, added to whatever other OCD medications they are taking.
| Condition | Intervention | Phase |
|---|---|---|
|
Obsessive-Compulsive Disorder |
Drug: N-Acetylcysteine Drug: placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
| Official Title: | A Double-Blind Study of N-Acetylcysteine Augmentation in Serotonin Reuptake Inhibitor-Refractory Obsessive-Compulsive Disorder and Depression |
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
N-Acetylcysteine: Experimental
Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment
|
Drug: N-Acetylcysteine
3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks
|
|
placebo: Placebo Comparator
Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
|
Drug: placebo
placebo, 2 capsules PO AM, 3 capsules PO PM, 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 |
| United States, Connecticut | |
| Yale OCD Research Clinic | Recruiting |
| New Haven, Connecticut, United States, 06519 | |
| Contact: Suzanne Wasylink, RN 203-974-7523 | |
| Principal Investigator: Christopher J Pittenger, MD, PhD | |
| Sub-Investigator: Gerard Sanacora, MD,PhD | |
| Sub-Investigator: Vladimir Coric, MD | |
| Principal Investigator: | Christopher J Pittenger, MD, Ph.D. | Yale University |
More Information
| Responsible Party: | Yale University ( Christopher Pittenger, MD, PhD; Principal Investigator ) |
| Study ID Numbers: | YOCD-2 |
| Study First Received: | October 2, 2007 |
| Last Updated: | January 13, 2010 |
| ClinicalTrials.gov Identifier: | NCT00539513 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
obsessive-compulsive disorder OCD glutamate N-Acetylcysteine augmentation |
|
Acetylcysteine N-monoacetylcystine Anti-Infective Agents Respiratory System Agents Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Antioxidants Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Protective Agents Antiviral Agents |
Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Pathologic Processes Anxiety Disorders Mental Disorders Expectorants Therapeutic Uses Free Radical Scavengers Obsessive-Compulsive Disorder Antidotes |