Trial · NCT00523718
Riluzole Augmentation in Treatment-refractory Obsessive-compulsive Disorder
NCT00523718, Phase 2, Completed, Yale University; results first posted 2016-03-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Riluzole Augmentation in Treatment-refractory Obsessive-compulsive Disorder. Trials, record NCT00523718. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00523718
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Riluzole Augmentation in Treatment-refractory Obsessive-compulsive Disorder
- NCT number
- NCT00523718
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- Yale University
- Conditions
- Obsessive-compulsive Disorder, Ocd
- Interventions
- riluzole, placebo
- First posted
- 2007-08-31
- Last updated
- 2020-03-06
- Results first posted
- 2016-03-23
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Partial Responders by Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) | 14 weeks | The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is a test to rate the severity of obsessive-compulsive disorder (OCD) symptoms. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms), yielding a total possible score range from 0 to 40. The results can be interpreted based on the total score: 0-7 is sub-clinical; 8-15 is mild; 16-23 is moderate; 24-31 is severe; 32-40 is extreme. Improvement was defined apriori as a 25% improvement from baseline |
| Secondary | Average Hamilton Depression Inventory (HAM-D) | 14 weeks | The HDRS (also known as the HAM-D) is the most widely used clinician-administered depression assessment scale. The HAM-D 17-item scale ranges from 0 (normal) to \>23 (very severe depression), with a maximum score of 52. The 24-item scale has a maximum score of 75. Severity of depression (e.g. "normal" or "very severe") is based upon the score in the first 17-items. |
| Secondary | Average Hamilton Anxiety Inventory (HAM-A) | 14 weeks | The Hamilton Anxiety Rating Scale (HARS or HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety. Total score ranges from 0 to 56. A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity. A score of 25 to 30 indicates a moderate to severe anxiety severity. A score of 31 or greater represents very severe anxiety severity. |
| Secondary | Clinical Global Impression (CGI) - Severity of Illness Item | 14 weeks | The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Partial Responders by Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) | 14 weeks | participants | NUMBER | |
| SECONDARY | Average Hamilton Depression Inventory (HAM-D) | 14 weeks | units on a scale | MEAN | |
| SECONDARY | Average Hamilton Anxiety Inventory (HAM-A) | 14 weeks | units on a scale | MEAN | |
| SECONDARY | Clinical Global Impression (CGI) - Severity of Illness Item | 14 weeks | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Partial Responders by Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) | Riluzole | 5 | participants | ||
| Partial Responders by Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) | Placebo | 2 | participants | ||
| Average Hamilton Depression Inventory (HAM-D) | Riluzole | 11.941 | Standard Deviation 6.91 | units on a scale | |
| Average Hamilton Depression Inventory (HAM-D) | Placebo | 12.53 | Standard Deviation 5.67 | units on a scale | |
| Average Hamilton Anxiety Inventory (HAM-A) | Riluzole | 14.176 | Standard Deviation 6.80 | units on a scale | |
| Average Hamilton Anxiety Inventory (HAM-A) | Placebo | 14.263 | Standard Deviation 6.19 | units on a scale | |
| Clinical Global Impression (CGI) - Severity of Illness Item | Riluzole | 3.94 | Standard Deviation 1.09 | units on a scale | |
| Clinical Global Impression (CGI) - Severity of Illness Item | Placebo | 3.95 | Standard Deviation 1.026 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Riluzole | 20 | |
| Overall Study | STARTED | Placebo | 18 | |
| Overall Study | COMPLETED | Riluzole | 17 | |
| Overall Study | COMPLETED | Placebo | 18 | |
| Overall Study | NOT COMPLETED | Riluzole | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Riluzole | 3 | 16 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 1 | 17 | |
| other | Poor Coordination | Nervous system disorders | Riluzole | 3 | 16 | |
| other | Poor Coordination | Nervous system disorders | Placebo | 1 | 17 | |
| other | Constipation | Gastrointestinal disorders | Riluzole | 1 | 16 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 6 | 17 | |
| other | Pounding Heart Beat | Cardiac disorders | Riluzole | 0 | 16 | |
| other | Pounding Heart Beat | Cardiac disorders | Placebo | 3 | 17 | |
| serious | Passively Suicidal | Psychiatric disorders | Riluzole | 1 | 19 | 1 |
| serious | Passively Suicidal | Psychiatric disorders | Placebo | 0 | 18 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Riluzole | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Riluzole | 7 | 16 |
| Total, other adverse events | Placebo | 11 | 17 |
| Total, serious adverse events | Riluzole | 1 | 19 |
| Total, serious adverse events | Placebo | 1 | 18 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R34MH083115 | Targeting Glutamate in OCD: A Placebo-Controlled, Double-Blind Augmentation Trial | PITTENGER, CHRISTOPHER JOHN | YALE UNIVERSITY | NATIONAL INSTITUTE OF MENTAL HEALTH | 2009 to 2011 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Riluzole vs Placebo: Partial Responders by Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) | Trial comparisons |
| Riluzole vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00523718
GET https://conductscience.org/api/trials/v1/NCT00523718/registered