Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00523718
Status:
COMPLETED
Last Update Posted:
2020-03-06
First Post:
2007-08-29
Brief Title:
Riluzole Augmentation in Treatment-refractory Obsessive-compulsive Disorder
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
A Double-blind Study of Riluzole Augmentation in Serotonin Reuptake Inhibitor-refractory Obsessive-compulsive Disorder and Depression
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Gehrigs 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
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 Gehrigs 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R34MH083115 | NIH | None | httpsreporternihgovquickSearchR34MH083115 |