Trial · NCT01828515
Vilazodone for Corticosteroid-Induced Memory Impairment
NCT01828515, Phase 2, Completed, University of Texas Southwestern Medical Center; results first posted 2018-07-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vilazodone for Corticosteroid-Induced Memory Impairment. Trials, record NCT01828515. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01828515
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vilazodone for Corticosteroid-Induced Memory Impairment
- NCT number
- NCT01828515
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- University of Texas Southwestern Medical Center
- Conditions
- Memory Impairment
- Interventions
- Vilazodone, Placebo, Hydrocortisone
- First posted
- 2013-04-10
- Last updated
- 2019-04-11
- Results first posted
- 2018-07-05
- Limitations and caveats
The sample size was modest and attrition rate was high; The study also lacked neuroimaging or other biomarkers to correlate changes in memory; Study drug adherence was only assessed with pill counts not with metered dosing counts or blood levels.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline RAVLT (Rey Auditory Verbal Learning Test) Total T-Score at Day 19 | Baseline and Day 19 | The Rey Auditory Verbal Learning Test (RAVLT) measures verbal or declarative learning and memory. The test consists of 15 nouns read aloud for five consecutive trials with each trial followed by a free-recall trial. Following the fifth trial, an interference list of 15 different words is presented followed by a free-recall trial of that list. Delayed recall of the first list is tested immediately following the interference list and after a 20-minute delay. Equivalent, alternative versions (different words) were used to minimize practice or learning effects from repeated administration. The raw scores (number of words correct across trials 1-5) are converted to standardized T-scores (M=50; SD=10). This score is used to determine the participant's performance in relation to norm-referenced expectations based on age and sex. Higher score reflects better performance, and the values reflect scores at baseline minus the scores at Day 19. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline RAVLT (Rey Auditory Verbal Learning Test) Total T-Score at Day 19 | Baseline and Day 19 | All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis. | T-score | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline RAVLT (Rey Auditory Verbal Learning Test) Total T-Score at Day 19 | Vilazodone and Hydrocortisone | -3 | Standard Deviation 12.48 | T-score | |
| Change From Baseline RAVLT (Rey Auditory Verbal Learning Test) Total T-Score at Day 19 | Placebo and Hydrocortisone | 0 | Standard Deviation 7.98 | T-score |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention (19 Days) | STARTED | Vilazodone and Hydrocortisone,Then Placebo and Hydrocortisone | 13 | |
| First Intervention (19 Days) | STARTED | Placebo and Hydrocortisone, Then Vilazodone and Hydrocortisone | 11 | |
| First Intervention (19 Days) | COMPLETED | Vilazodone and Hydrocortisone,Then Placebo and Hydrocortisone | 11 | |
| First Intervention (19 Days) | COMPLETED | Placebo and Hydrocortisone, Then Vilazodone and Hydrocortisone | 9 | |
| First Intervention (19 Days) | NOT COMPLETED | Vilazodone and Hydrocortisone,Then Placebo and Hydrocortisone | 2 | |
| First Intervention (19 Days) | NOT COMPLETED | Placebo and Hydrocortisone, Then Vilazodone and Hydrocortisone | 2 | |
| Washout (23 Days) | STARTED | Vilazodone and Hydrocortisone,Then Placebo and Hydrocortisone | 11 | |
| Washout (23 Days) | STARTED | Placebo and Hydrocortisone, Then Vilazodone and Hydrocortisone | 9 | |
| Washout (23 Days) | COMPLETED | Vilazodone and Hydrocortisone,Then Placebo and Hydrocortisone | 6 | |
| Washout (23 Days) | COMPLETED | Placebo and Hydrocortisone, Then Vilazodone and Hydrocortisone | 8 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events4
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 | Back Pain | Musculoskeletal and connective tissue disorders | Vilazodone and Hydrocortisone | 1 | 24 | 1 |
| other | Back Pain | Musculoskeletal and connective tissue disorders | Placebo and Hydrocortisone | 0 | 24 | 0 |
| other | Varicocele | Vascular disorders | Vilazodone and Hydrocortisone | 1 | 24 | 1 |
| other | Varicocele | Vascular disorders | Placebo and Hydrocortisone | 0 | 24 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vilazodone and Hydrocortisone | 0 | 24 |
| Total, all-cause mortality | Placebo and Hydrocortisone | 0 | 24 |
| Total, other adverse events | Vilazodone and Hydrocortisone | 2 | 24 |
| Total, other adverse events | Placebo and Hydrocortisone | 0 | 24 |
| Total, serious adverse events | Vilazodone and Hydrocortisone | 0 | 24 |
| Total, serious adverse events | Placebo and Hydrocortisone | 0 | 24 |
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 |
|---|---|
| Vilazodone and Hydrocortisone vs Placebo and Hydrocortisone: deaths from any cause | Trial comparisons |
| Vilazodone and Hydrocortisone vs Placebo and Hydrocortisone: 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 |
|---|---|
| Verbal Learning | Primary 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/NCT01828515
GET https://conductscience.org/api/trials/v1/NCT01828515/registered