Trial · NCT02155829
Safety Study of Riluzole to Treat Post-traumatic Stress Disorder (PTSD)
NCT02155829, Phase 1, Phase 2, Completed, Uniformed Services University of the Health Sciences; results first posted 2020-09-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety Study of Riluzole to Treat Post-traumatic Stress Disorder (PTSD). Trials, record NCT02155829. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02155829
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of Riluzole to Treat Post-traumatic Stress Disorder (PTSD)
- NCT number
- NCT02155829
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 75 participants, actual
- Lead sponsor
- Uniformed Services University of the Health Sciences
- Conditions
- PTSD
- Interventions
- Riluzole, Placebo (for Riluzole)
- First posted
- 2014-06-04
- Last updated
- 2021-05-24
- Results first posted
- 2020-09-25
- Limitations and caveats
- Result limited to combat-related PTSD in military and veterans of recent conflict.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinician Administered PTSD Scale (CAPS) Score | Week 1 and 8 | CAPS is a 30-item structured interview that can be used to make current (past month) diagnoses of PTSD, make lifetime diagnoses of PTSD, and assess PTSD symptoms over the past week. A summed score of 17 items: Minimum Score: 0 (no symptoms) Maximum Score: 136 (very severe symptoms) Subscales: Subscale B (re-experiencing): items 1-5, a score of 0-40. Subscale C (avoidance): items 6-12, a score of 0-56. Subscale D (hyperarousal): items 13-17, a score of 0-40. CAPS scores were measured at baseline, mid-treatment, and post-treatment. For outcome analyses, differences between pre-treatment and post-treatment scores were used. |
| Secondary | PTSD Check List Specific (PCL-S) | Week 1 and 8 | A 17-item self-report measure used to assess PTSD symptoms related to a specific traumatic event. Scoring: A sum of all 17 items. Minimum: 17 (no symptoms) Maximum: 85 (very severe symptoms) PCL-S scores were measured at every study visit. For outcome analyses, differences between pre-treatment and post-treatment scores were used. |
| Secondary | Montgomery-Åsberg Depression Rating Scale (MADRS) Score | Week 1 and 8 | A ten-item diagnostic questionnaire to measure the severity of depressive episodes. Scoring: A sum of all 10 items. Minimum: 0 (no symptoms) Maximum: 60 (very severe symptoms) MADRS scores were measured at every study visit. For outcome analyses, differences between pre-treatment and post-treatment scores were used. |
| Secondary | Hamilton Anxiety Rating Scale (HAM-A) | Week 1 and 8 | A 14-item clinician-administered assessment measuring anxiety symptoms. Scoring: A sum of all 14 items. Minimum: 0 (no symptoms) Maximum: 56 (very severe symptoms) HAM-A scores were measured at baseline, mid-treatment, and post-treatment. For outcome analyses, differences between pre-treatment and post-treatment scores were used. |
| Secondary | Sheehan Disability Scale (SDS) Score | Week 1 and 8 | A 3-item self-report measure to assess functional impairment in work/school, social, and family life. Scoring: A sum of all 3 items. Minimum: 0 (no symptoms) Maximum: 30 (very severe symptoms) SDS scores were measured at baseline, mid-treatment, and post-treatment. For outcome analyses, differences between pre-treatment and post-treatment scores were used. |
| Secondary | Clinician Administered PTSD Subscale D (CAPS-D) | Week 1 and 8 | Subscale D (items 13-17 on the CAPS-IV) measures Hyperarousal symptoms of PTSD Scoring: A sum of items 13-17. Minimum: 0 (no symptoms) Maximum: 40 (very severe symptoms) CAPS-D scores were measured at baseline, mid-treatment, and post-treatment. For outcome analyses, differences between pre-treatment and post-treatment scores were used. |
| Secondary | PTSD Checklist - D (PCL-D) | Week 1 and week 8 | The subscale D (items 13-17 on the PCL) measures hyperarousal symptoms of PTSD. Scoring: A sum of items 13 to 17. Minimum: 5 (no symptoms) Maximum: 25 (very severe symptoms) PCL-D scores were measured at baseline, mid-treatment, and post-treatment. For outcome analyses, differences between pre-treatment and post-treatment scores were used. |
| Other | NAA/Cr Ratio | Measured at study start (Week 0) for baseline and measured at study completion (Week 8) | The N-acetyl aspartate to creatine ratio (NAA/Cr) in the hippocampus and anterior cingulate, measured using magnetic resonance spectroscopy (1H MRS), will be evaluated for change after 8-week treatment with riluzole. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinician Administered PTSD Scale (CAPS) Score | Week 1 and 8 | One participant failed to meet minimum Clinician-Administered PTSD Scale IV (CAPS-IV) score for inclusion at phase 2 baseline and was excluded from intent-to treat (ITT) analyses. | score on a scale | MEAN |
| SECONDARY | PTSD Check List Specific (PCL-S) | Week 1 and 8 | One participant failed to meet minimum Clinician-Administered PTSD Scale IV (CAPS-IV) score for inclusion at phase 2 baseline and was excluded from intent-to treat (ITT) analyses. | score on a scale | MEAN |
| SECONDARY | Montgomery-Åsberg Depression Rating Scale (MADRS) Score | Week 1 and 8 | One participant failed to meet minimum Clinician-Administered PTSD Scale IV (CAPS-IV) score for inclusion at phase 2 baseline and was excluded from intent-to treat (ITT) analyses. | score on a scale | MEAN |
| SECONDARY | Hamilton Anxiety Rating Scale (HAM-A) | Week 1 and 8 | One participant failed to meet minimum Clinician-Administered PTSD Scale IV (CAPS-IV) score for inclusion at phase 2 baseline and was excluded from intent-to treat (ITT) analyses. | score on a scale | MEAN |
| SECONDARY | Sheehan Disability Scale (SDS) Score | Week 1 and 8 | One participant failed to meet minimum Clinician-Administered PTSD Scale IV (CAPS-IV) score for inclusion at phase 2 baseline and was excluded from intent-to treat (ITT) analyses. | score on a scale | MEAN |
| SECONDARY | Clinician Administered PTSD Subscale D (CAPS-D) | Week 1 and 8 | One participant failed to meet minimum Clinician-Administered PTSD Scale IV (CAPS-IV) score for inclusion at phase 2 baseline and was excluded from intent-to treat (ITT) analyses. | score on a scale | MEAN |
| SECONDARY | PTSD Checklist - D (PCL-D) | Week 1 and week 8 | One participant failed to meet minimum Clinician-Administered PTSD Scale IV (CAPS-IV) score for inclusion at phase 2 baseline and was excluded from intent-to treat (ITT) analyses. | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | NAA/Cr Ratio | Measured at study start (Week 0) for baseline and measured at study completion (Week 8) |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinician Administered PTSD Scale (CAPS) Score | Riluzole | -21.1 | Standard Deviation 18.9 | score on a scale | |
| Clinician Administered PTSD Scale (CAPS) Score | Placebo | -16.7 | Standard Deviation 17.2 | score on a scale | |
| PTSD Check List Specific (PCL-S) | Riluzole | -15.4 | Standard Deviation 13.5 | score on a scale | |
| PTSD Check List Specific (PCL-S) | Placebo | -14.5 | Standard Deviation 11.4 | score on a scale | |
| Montgomery-Åsberg Depression Rating Scale (MADRS) Score | Riluzole | -7.9 | Standard Deviation 7.6 | score on a scale | |
| Montgomery-Åsberg Depression Rating Scale (MADRS) Score | Placebo | -8.2 | Standard Deviation 9.6 | score on a scale | |
| Hamilton Anxiety Rating Scale (HAM-A) | Riluzole | -7.8 | Standard Deviation 7.4 | score on a scale | |
| Hamilton Anxiety Rating Scale (HAM-A) | Placebo | -6.7 | Standard Deviation 6.9 | score on a scale | |
| Sheehan Disability Scale (SDS) Score | Riluzole | -6.3 | Standard Deviation 6.8 | score on a scale | |
| Sheehan Disability Scale (SDS) Score | Placebo | -5.7 | Standard Deviation 5.9 | score on a scale |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Riluzole | 37 | |
| Overall Study | STARTED | Placebo | 38 | |
| Overall Study | COMPLETED | Riluzole | 31 | |
| Overall Study | COMPLETED | Placebo | 35 | |
| Overall Study | NOT COMPLETED | Riluzole | 6 | |
| Overall Study | NOT COMPLETED | Placebo | 3 |
Source ClinicalTrials.gov
Adverse events6
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 | Gastrointestinal Symptoms | Gastrointestinal disorders | Riluzole | 2 | 37 | 2 |
| other | Gastrointestinal Symptoms | Gastrointestinal disorders | Placebo | 0 | 38 | 0 |
| other | LFT Elevation | Hepatobiliary disorders | Riluzole | 2 | 37 | 2 |
| other | LFT Elevation | Hepatobiliary disorders | Placebo | 0 | 38 | 0 |
| other | Clinical deterioration | Psychiatric disorders | Riluzole | 1 | 37 | 1 |
| other | Clinical deterioration | Psychiatric disorders | Placebo | 0 | 38 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Riluzole | 0 | 37 |
| Total, all-cause mortality | Placebo | 0 | 38 |
| Total, other adverse events | Riluzole | 2 | 37 |
| Total, other adverse events | Placebo | 0 | 38 |
| Total, serious adverse events | Riluzole | 0 | 37 |
| Total, serious adverse events | Placebo | 0 | 38 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33113596 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Riluzole vs Placebo: deaths from any cause | 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/NCT02155829
GET https://conductscience.org/api/trials/v1/NCT02155829/registered