Riluzole Augmentation in Treatment-Refractory Obsessive-Compulsive Disorder
Information source: Yale University
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obsessive-Compulsive Disorder
Intervention: riluzole (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:
Suzanne Wasylink, RN, Phone: 203-974-7523
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 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.
Clinical Details
Official title: A Double-Blind Study of Riluzole Augmentation in Serotonin Reuptake Inhibitor-Refractory Obsessive-Compulsive Disorder and Depression
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
Secondary outcome: Hamilton Depression Inventory (HAM-D)Hamilton Anxiety Inventory (HAM-A) Clinical Global Impression (CGI) - Severity of Illness item
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 riluzole
- 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
Suzanne Wasylink, RN, Phone: 203-974-7523
Yale OCD Research Clinic, New Haven, Connecticut 06508, United States; Recruiting
Suzane Wasylink, RN, Phone: 203-974-7523
Christoper J Pittenger, MD, Ph.D., Principal Investigator
Gerard Sanacora, MD, Ph.D., Sub-Investigator
Vladimir Coric, MD, Sub-Investigator
Additional Information
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: September 2006
Ending date: December 2010
Last updated: October 30, 2008
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