N-Acetylcysteine Augmentation in Treatment-Refractory Obsessive-Compulsive Disorder
Information source: Yale University
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obsessive-Compulsive Disorder
Intervention: N-Acetylcysteine (Drug); placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Yale University Official(s) and/or principal investigator(s):
Christopher J Pittenger, MD, Ph.D., Principal Investigator, Affiliation: Yale University
Overall contact:
Eileen Billingslea, MA, Phone: 203-974-7768, Email: eileen.billingslea@yale.edu
Summary
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.
Clinical Details
Official title: A Double-Blind Study of N-Acetylcysteine Augmentation in Serotonin Reuptake Inhibitor-Refractory Obsessive-Compulsive Disorder and Depression
Study design: Allocation: Randomized, Control: Placebo Control, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
Secondary outcome: Hamilton Depression Inventory (HAM-D)Clinical Global Impression (CGI) - Severity of Illness item Hamilton Anxiety Inventory (HAM-A)
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- DSM-IV diagnosis of OCD, confirmed by SCID-IV; symptoms of at least 1 year duration
- moderate to severe OCD symptoms (Y-BOCS > 16)
- documented failure of an adequate trial of an SSRI
- agreement to engage in a reliable form of birth control (women only)
Exclusion Criteria:
- primary diagnosis of a psychotic disorder
- active substance abuse or dependence
- unstable medical condition
- prior exposure to N-Acetylcysteine
- prior psychosurgery
- pregnancy, breastfeeding, or intent to become pregnant during study
- liver function tests (LFTs) elevated to more than 2x the upper limit of normal
- evidence of active liver disease
- seizure disorder
- active suicidal ideation
Locations and Contacts
Eileen Billingslea, MA, Phone: 203-974-7768, Email: eileen.billingslea@yale.edu
Yale OCD Research Clinic, New Haven, Connecticut 06519, United States; Recruiting
Suzanne Wasylink, RN, Phone: 203-974-7523
Christopher J Pittenger, MD, PhD, Principal Investigator
Gerard Sanacora, MD,PhD, Sub-Investigator
Vladimir Coric, MD, Sub-Investigator
Additional Information
link to research clinic at yale - then select OCD Research Clinic
Related publications: Pittenger C, Krystal JH, Coric V. Glutamate-modulating drugs as novel pharmacotherapeutic agents in the treatment of obsessive-compulsive disorder. NeuroRx. 2006 Jan;3(1):69-81. Review. Coric V, Taskiran S, Pittenger C, Wasylink S, Mathalon DH, Valentine G, Saksa J, Wu YT, Gueorguieva R, Sanacora G, Malison RT, Krystal JH. Riluzole augmentation in treatment-resistant obsessive-compulsive disorder: an open-label trial. Biol Psychiatry. 2005 Sep 1;58(5):424-8.
Starting date: June 2006
Last updated: January 13, 2010
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