Trial · NCT01956279
Complementary Neurosteroid Intervention in Gulf War Illnesses (GWVI)
NCT01956279, Phase 2, Completed, VA Office of Research and Development; results first posted 2020-05-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Complementary Neurosteroid Intervention in Gulf War Illnesses (GWVI). Trials, record NCT01956279. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01956279
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Complementary Neurosteroid Intervention in Gulf War Illnesses (GWVI)
- NCT number
- NCT01956279
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 170 participants, actual
- Lead sponsor
- VA Office of Research and Development
- Conditions
- Fatigue, Musculoskeletal Pain, Cognitive Decline
- Interventions
- Pregnenolone, Placebo
- First posted
- 2013-10-08
- Last updated
- 2020-05-01
- Results first posted
- 2020-05-01
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Physical Component of the SF-36 | Baseline to week 4, and Baseline to week 8 | These data report changes in the mean scores in physical health symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The SF-36 is a health survey with an 8-scale profile embedded in 36 questions that measures physical and mental components of health. Each item is scored on a 0 to 100 range, with the lowest and highest possible scores set at 0 and 100, respectively. All of these items are scored such that a high score defines a more favorable health state, and the Physical Component Score is an average of 4 of the 8 domains of the SF-36. Thus, positive changes in scores represent an improvement relative to baseline. |
| Secondary | Brief Pain Inventory (BPI) | Baseline to week 4, and Baseline to week 8 | These data report changes in the mean scores in pain symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The Brief Pain Inventory is a 14-item self-report measure designed to assess the severity, frequency and daily pattern of pain, as well as its perceived interference with quality of life. Severity is measured on a 0-10 scale with 10 being the greatest pain. Interference score is measured by a mean score of 7 items (0-10 scale) with 10 being the greatest interference. Thus, negative changes in scores represent an improvement relative to baseline. |
| Secondary | Tower of London Test of the Brief Assessment of Cognition in Affective Disorders (BAC-A) | Baseline to week 4, and Baseline to week 8 | These data report changes in the mean scores in cognitive symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The Tower of London test assesses executive functioning on a scale of 0-20. (Note, if a perfect score of 20 occurs then there is the opportunity of 2 additional points, increasing the score to 22.) The higher the number, the higher the degree of executive functioning. Thus, positive changes in scores represent an improvement relative to baseline. |
| Secondary | Multidimensional Fatigue Inventory (MFI) | Baseline to week 4, and Baseline to week 8 | These data report changes in the mean scores in fatigue symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The MFI is a 20-item self-report measure designed to assess the principal manifestations of fatigue. Items are rated on a 1-5 scale indicating how true each statement was for the respondent during the last week, with some questions scored in an inverse fashion in the final calculation of the score. The 20 items are then summed, with higher scores representing greater fatigue. Thus, negative changes in scores represent an improvement relative to baseline. |
| Secondary | Global Severity Index of the Symptom Checklist-90-Revised (SCL-90R) | Baseline to week 4, and Baseline to week 8 | These data report changes in the mean scores in psychiatric symptoms at Week 8 Post-Randomization and Week 4 Post-Randomization, relative to Baseline. The SCL-90R is used as a screening measure of general psychiatric symptomatology. It includes dimensions measuring somatization, obsessive-compulsive, depression, anxiety, phobic anxiety, hostility, interpersonal sensitivity, paranoid ideation, and psychoticism. Global Severity Index (GSI) of the SCL-90R is designed to measure overall psychological distress. Higher scores reflect greater distress. This is a 90 item measure with each rated on a scale of 0-4, with 4 being the highest level of psychological distress for each item. Thus, negative changes in scores represent an improvement relative to baseline. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Physical Component of the SF-36 | Baseline to week 4, and Baseline to week 8 | Change in the Physical Component Score of the SF-36. Some subjects did not reach week 8 of the study, and not all subjects completed all information at all visits. | score on a scale | MEAN |
| SECONDARY | Brief Pain Inventory (BPI) | Baseline to week 4, and Baseline to week 8 | Change in the average pain rating over the last 24 hours, and the magnitude of interference resulting from that pain. Some subjects did not reach week 8 of the study, and not all subjects completed all information at all visits. | score on a scale | MEAN |
| SECONDARY | Tower of London Test of the Brief Assessment of Cognition in Affective Disorders (BAC-A) | Baseline to week 4, and Baseline to week 8 | Change in the Tower of London Score of the BAC-A. Some subjects did not reach week 8 of the study. | score on a scale | MEAN |
| SECONDARY | Multidimensional Fatigue Inventory (MFI) | Baseline to week 4, and Baseline to week 8 | Total score of the MFI-20. Some subjects did not reach week 8 of the study, and not all subjects completed all information at all visits. | score on a scale | MEAN |
| SECONDARY | Global Severity Index of the Symptom Checklist-90-Revised (SCL-90R) | Baseline to week 4, and Baseline to week 8 | Average Global Severity Index score of the SCL-90. Some subjects did not reach week 8 of the study, and not all subjects completed all information at all visits. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Physical Component of the SF-36 | Pregnenolone (Arm 1) | Baseline to week 4 | 2.04 | Standard Error 1.50 | score on a scale |
| Physical Component of the SF-36 | Placebo (Arm 2) | Baseline to week 4 | 2.55 | Standard Error 1.55 | score on a scale |
| Physical Component of the SF-36 | Pregnenolone (Arm 1) | Baseline to week 8 | 1.23 | Standard Error 1.68 | score on a scale |
| Physical Component of the SF-36 | Placebo (Arm 2) | Baseline to week 8 | 4.45 | Standard Error 1.75 | score on a scale |
| Brief Pain Inventory (BPI) | Pregnenolone (Arm 1) | Pain rating, Baseline to week 4 | -0.44 | Standard Error 0.14 | score on a scale |
| Brief Pain Inventory (BPI) | Placebo (Arm 2) | Pain rating, Baseline to week 4 | -0.30 | Standard Error 0.15 | score on a scale |
| Brief Pain Inventory (BPI) | Pregnenolone (Arm 1) | Pain rating, Baseline to week 8 | -0.09 | Standard Error 0.21 | score on a scale |
| Brief Pain Inventory (BPI) | Placebo (Arm 2) | Pain rating, Baseline to week 8 | -0.11 | Standard Error 0.22 | score on a scale |
| Brief Pain Inventory (BPI) | Pregnenolone (Arm 1) | Interference, Baseline to week 4 | -0.03 | Standard Error 0.22 | score on a scale |
| Brief Pain Inventory (BPI) | Placebo (Arm 2) | Interference, Baseline to week 4 | 0.00 | Standard Error 0.21 | score on a scale |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pregnenolone (Arm 1) | 82 | |
| Overall Study | STARTED | Placebo (Arm 2) | 88 | |
| Overall Study | COMPLETED | Pregnenolone (Arm 1) | 68 | |
| Overall Study | COMPLETED | Placebo (Arm 2) | 74 | |
| Overall Study | NOT COMPLETED | Pregnenolone (Arm 1) | 14 | |
| Overall Study | NOT COMPLETED | Placebo (Arm 2) | 14 |
Source ClinicalTrials.gov
Adverse events114
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 | Cold Extremities | Blood and lymphatic system disorders | Pregnenolone (Arm 1) | 4 | 82 | |
| other | Cold Extremities | Blood and lymphatic system disorders | Placebo (Arm 2) | 12 | 88 | |
| other | Palpitations | Cardiac disorders | Pregnenolone (Arm 1) | 5 | 82 | |
| other | Palpitations | Cardiac disorders | Placebo (Arm 2) | 8 | 88 | |
| other | Tachycardia | Cardiac disorders | Pregnenolone (Arm 1) | 3 | 82 | |
| other | Tachycardia | Cardiac disorders | Placebo (Arm 2) | 1 | 88 | |
| other | Tinnitus | Ear and labyrinth disorders | Pregnenolone (Arm 1) | 11 | 82 | |
| other | Tinnitus | Ear and labyrinth disorders | Placebo (Arm 2) | 15 | 88 | |
| other | Blurred Vision | Eye disorders | Pregnenolone (Arm 1) | 10 | 82 | |
| other | Blurred Vision | Eye disorders | Placebo (Arm 2) | 19 | 88 |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pregnenolone (Arm 1) | 1 | 82 |
| Total, all-cause mortality | Placebo (Arm 2) | 0 | 88 |
| Total, other adverse events | Pregnenolone (Arm 1) | 69 | 82 |
| Total, other adverse events | Placebo (Arm 2) | 73 | 88 |
| Total, serious adverse events | Pregnenolone (Arm 1) | 1 | 82 |
| Total, serious adverse events | Placebo (Arm 2) | 0 | 88 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|
| Pregnenolone (Arm 1) vs Placebo (Arm 2): deaths from any cause | Trial comparisons |
| Pregnenolone (Arm 1) vs Placebo (Arm 2): serious adverse events | Trial comparisons |
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Tower Planning | Secondary outcome |
Source ConductCognition
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/NCT01956279
GET https://conductscience.org/api/trials/v1/NCT01956279/results?page=2