Trial · NCT01204918
Efficacy and Tolerability of Riluzole in Treatment Resistant Depression
NCT01204918, Phase 2, Completed, Yale University; results first posted 2018-02-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Tolerability of Riluzole in Treatment Resistant Depression. Trials, record NCT01204918. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01204918
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Tolerability of Riluzole in Treatment Resistant Depression
- NCT number
- NCT01204918
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 104 participants, actual
- Lead sponsor
- Yale University
- Conditions
- Depression
- Interventions
- Riluzole, placebo
- First posted
- 2010-09-17
- Last updated
- 2020-03-06
- Results first posted
- 2018-02-08
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Montgomery and Asberg Depression Rating Scale (MADRS) | 4 weeks of therapy (baseline to week 4) | This 10 item instrument is completed by the clinician by using a structured interview and defined anchor points, and aims to quantify the degree of depression over the past 7 days. The MADRS is a widely studied instrument for depression, and its reliability and validity are high. This instrument is administered at every study visit during the double-blind RCT, and at the screening, and baseline. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Usual cutoff points are: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression |
| Primary | Change in Montgomery and Asberg Depression Rating Scale (MADRS) | 4 weeks of therapy (week 4 to week 8) | This 10 item instrument is completed by the clinician by using a structured interview and defined anchor points, and aims to quantify the degree of depression over the past 7 days. The MADRS is a widely studied instrument for depression, and its reliability and validity are high. This instrument is administered at every study visit during the double-blind RCT, and at the screening, and baseline. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Usual cutoff points are: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression |
| Secondary | Responders Having at Least a 50% Improvement in MADRS Compared to the Baseline | 8 weeks therapy | Responders having at least a 50% improvement in MADRS compared to the baseline in the sequential parallel design |
| Secondary | Systematic Assessment for Treatment Emergent Events (SAFTEE-SI) | 8 weeks | A commonly used instrument originally developed by NIMH and adapted into a self-report instrument. The version of the scale that we plan to use examines in a systematic fashion all possible treatment-emergent side effects and probes specific adverse symptoms, including suicidal thoughts and behaviors, and self-injurious behavior. Presented below are counts of people that had experienced the event by 8 weeks. |
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 | Change in Montgomery and Asberg Depression Rating Scale (MADRS) | 4 weeks of therapy (baseline to week 4) | units on a scale | MEAN | |
| PRIMARY | Change in Montgomery and Asberg Depression Rating Scale (MADRS) | 4 weeks of therapy (week 4 to week 8) | units on a scale | MEAN | |
| SECONDARY | Responders Having at Least a 50% Improvement in MADRS Compared to the Baseline | 8 weeks therapy | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Systematic Assessment for Treatment Emergent Events (SAFTEE-SI) | 8 weeks | All subjects are included in the analysis- with the exception of sex specific conditions. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group174
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Montgomery and Asberg Depression Rating Scale (MADRS) | Riluzole Addition to SSRI Antidepressant | 3.20 | Standard Deviation 3.86 | units on a scale | |
| Change in Montgomery and Asberg Depression Rating Scale (MADRS) | Riluzole/Placebo Addition to SSRI Antidepressant | 5.77 | Standard Deviation 0.52 | units on a scale | |
| Change in Montgomery and Asberg Depression Rating Scale (MADRS) | Placebo Addition to Standard SSRI Antidepressant | 4.83 | Standard Deviation 7.85 | units on a scale | |
| Change in Montgomery and Asberg Depression Rating Scale (MADRS) | Riluzole Addition to SSRI Antidepressant | 4.13 | Standard Deviation 6.82 | units on a scale | |
| Change in Montgomery and Asberg Depression Rating Scale (MADRS) | Riluzole/Placebo Addition to SSRI Antidepressant | 0.84 | Standard Deviation 5.79 | units on a scale | |
| Change in Montgomery and Asberg Depression Rating Scale (MADRS) | Placebo Addition to Standard SSRI Antidepressant | 3.87 | Standard Deviation 6.49 | units on a scale | |
| Responders Having at Least a 50% Improvement in MADRS Compared to the Baseline | Riluzole Addition to SSRI Antidepressant | 6 | Participants | ||
| Responders Having at Least a 50% Improvement in MADRS Compared to the Baseline | Riluzole/Placebo Addition to SSRI Antidepressant | 8 | Participants | ||
| Responders Having at Least a 50% Improvement in MADRS Compared to the Baseline | Placebo Addition to Standard SSRI Antidepressant | 10 | Participants | ||
| Systematic Assessment for Treatment Emergent Events (SAFTEE-SI) | Riluzole Addition to SSRI Antidepressant | Trouble Sleeping | 17 | participants |
1 to 10 of 174Source ClinicalTrials.gov
See all 174 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Riluzole Addition to SSRI Antidepressant | 25 | |
| Overall Study | STARTED | Riluzole/Placebo Addition to SSRI Antidepressant | 39 | |
| Overall Study | STARTED | Placebo Addition to Standard SSRI Antidepressant | 40 | |
| Overall Study | Stage 1 Begin | Riluzole Addition to SSRI Antidepressant | 25 | |
| Overall Study | Stage 1 Begin | Riluzole/Placebo Addition to SSRI Antidepressant | 39 | |
| Overall Study | Stage 1 Begin | Placebo Addition to Standard SSRI Antidepressant | 40 | |
| Overall Study | Stage 1 End | Riluzole Addition to SSRI Antidepressant | 22 | |
| Overall Study | Stage 1 End | Riluzole/Placebo Addition to SSRI Antidepressant | 35 | |
| Overall Study | Stage 1 End | Placebo Addition to Standard SSRI Antidepressant | 36 | |
| Overall Study | Stage 2 Begin | Riluzole Addition to SSRI Antidepressant | 22 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events111
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 | Abdominal Pain | General disorders | Riluzole Addition to SSRI Antidepressant | 2 | 25 | |
| other | Abdominal Pain | General disorders | Riluzole/Placebo Addition to SSRI Antidepressant | 1 | 39 | |
| other | Abdominal Pain | General disorders | Placebo Addition to Standard SSRI Antidepressant | 0 | 40 | |
| other | Anxiety | Psychiatric disorders | Riluzole Addition to SSRI Antidepressant | 0 | 25 | |
| other | Anxiety | Psychiatric disorders | Riluzole/Placebo Addition to SSRI Antidepressant | 0 | 39 | |
| other | Anxiety | Psychiatric disorders | Placebo Addition to Standard SSRI Antidepressant | 2 | 40 | |
| other | Back Pain | General disorders | Riluzole Addition to SSRI Antidepressant | 3 | 25 | |
| other | Back Pain | General disorders | Riluzole/Placebo Addition to SSRI Antidepressant | 3 | 39 | |
| other | Back Pain | General disorders | Placebo Addition to Standard SSRI Antidepressant | 4 | 40 | |
| other | Blurred Vision | Eye disorders | Riluzole Addition to SSRI Antidepressant | 1 | 25 |
1 to 10 of 111Source ClinicalTrials.gov
See all 111 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Riluzole Addition to SSRI Antidepressant | 0 | 25 |
| Total, all-cause mortality | Riluzole/Placebo Addition to SSRI Antidepressant | 0 | 39 |
| Total, all-cause mortality | Placebo Addition to Standard SSRI Antidepressant | 0 | 40 |
| Total, other adverse events | Riluzole Addition to SSRI Antidepressant | 19 | 25 |
| Total, other adverse events | Riluzole/Placebo Addition to SSRI Antidepressant | 31 | 39 |
| Total, other adverse events | Placebo Addition to Standard SSRI Antidepressant | 34 | 40 |
| Total, serious adverse events | Riluzole Addition to SSRI Antidepressant | 1 | 25 |
| Total, serious adverse events | Riluzole/Placebo Addition to SSRI Antidepressant | 0 | 39 |
| Total, serious adverse events | Placebo Addition to Standard SSRI Antidepressant | 2 | 40 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01204918
GET https://conductscience.org/api/trials/v1/NCT01204918/results?page=2