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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
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The purpose of this study is to examine whether vilazodone attenuates the memory and mood effects of corticosteroids on the human hippocampus in 24 healthy controls.
In animals and humans, stress and corticosteroid excess are associated with changes in hippocampal structure and functioning. These findings have important implications to the millions of patients taking prescription corticosteroids and to patients with major depressive disorder or bipolar disorder who have elevated cortisol levels and memory impairment. The investigators believe that vilazodone may be a medication that can block the effects of hydrocortisone on the human hippocampus. The investigators propose to examine whether vilazodone attenuates the effects of corticosteroids in a randomized, double-blind, placebo-controlled pilot study using a within-subject crossover design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vilazodone and Hydrocortisone, then Placebo and Hydrocortisone | Experimental | Vilazodone titrated to 10 mg x 7 days, 20 mg x 7 days and 40 mg x 5 days (19 days) and hydrocortisone 160 mg x 4 days (days 16-19) following vilazodone pre-treatment. After a 23 day medication washout the procedure will be repeated using placebo daily for 19 days and hydrocortisone 160 mg x 4 days (days 16-19) following placebo pre-treatment. |
|
| Placebo and Hydrocortisone, then Vilazodone and Hydrocortisone | Experimental | Placebo daily for 19 days and hydrocortisone 160 mg x 4 days (days 16-19) following placebo pre-treatment. After a 23 day medication washout the procedure will be repeated using Vilazodone titrated to 10 mg x 7 days, 20 mg x 7 days and 40 mg x 5 days (19 days) and hydrocortisone 160 mg x 4 days (days 16-19) following vilazodone pre-treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vilazodone | Drug | Participants will be randomized to either vilazodone or placebo titrated as follows: 10 mg x 7 days, 20 mg x 7 days and 40 mg x 5 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline RAVLT (Rey Auditory Verbal Learning Test) Total T-Score at 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. | Baseline and Day 19 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| E. Sherwood Brown, M.D., Ph.D. | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
Healthy control participants without any history of major psychiatric illness, drug/alcohol abuse/dependence, history of neurological disorders, or significant medical conditions were included.
24 participants with at least one post-baseline visit were recruited at our research clinic in Dallas, TX and included for analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vilazodone and Hydrocortisone,Then Placebo and Hydrocortisone | Vilazodone was initiated at 10 mg/day for 7 days and increased to 20 mg/day for 7 days. After that time an additional increase to 40 mg/day for 5 days (totaling 19 days). On the 2nd day of the 40 mg a day portion, 160 mg of hydrocortisone/day was given for 4 days. After a washout period of 23 days, placebo was given for 19 days and hydrocortisone was given for 4 days. |
| FG001 | Placebo and Hydrocortisone, Then Vilazodone and Hydrocortisone | Placebo was given for 19 days and hydrocortisone was given for 4 days. After a washout period of 23 days, Vilazodone was initiated at 10 mg/day for 7 days and increased to 20 mg/day for 7 days. After that time an additional increase to 40 mg/day for 5 days (totaling 19 days). On the 2nd day of the 40 mg a day portion, 160 mg of hydrocortisone/day was given for 4 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (19 Days) |
| |||||||||||||
| Washout (23 Days) |
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| Second Intervention (19 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Participants who were randomized to receive either Vilazodone and hydrocortisone or placebo and hydrocortisone. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline RAVLT (Rey Auditory Verbal Learning Test) Total T-Score at 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. | All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis. | Posted | Mean | Standard Deviation | T-score | Baseline and Day 19 |
Adverse events were collected during the study between baseline and end of study procedures (after 2 complete cycles of treatment) or an average of 2 months.
Adverse events were assessed by a weekly questionnaire at each appointment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vilazodone and Hydrocortisone | Vilazodone was initiated at 10 mg/day for 7 days and increased to 20 mg/day for 7 days. After that time an additional increase to 40 mg/day for 5 days (totaling 19 days). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to the medication or study |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. E. Sherwood Brown | UT Southwestern Medical Center | 214-645-6950 | sherwood.brown@utsouthwestern.edu |
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| ID | Term |
|---|---|
| D008569 | Memory Disorders |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069503 | Vilazodone Hydrochloride |
| D006854 | Hydrocortisone |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001572 | Benzofurans |
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|
| Placebo | Drug |
|
| Hydrocortisone | Drug | Participants receive 160 mg x 4 days after vilazodone or placebo pre-treatment |
|
| NOT COMPLETED |
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| NOT COMPLETED |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Vilazodone and Hydrocortisone | Vilazodone was initiated at 10 mg/day for 7 days and increased to 20 mg/day for 7 days. After that time an additional increase to 40 mg/day for 5 days (totaling 19 days). On the 2nd day of the 40 mg a day portion, 160 mg of hydrocortisone/day was given for 4 days. |
| OG001 | Placebo and Hydrocortisone | Placebo was given for 19 days and hydrocortisone was given for 4 days. |
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 2 |
| 24 |
| EG001 | Placebo and Hydrocortisone | Placebo group received medication in identical color/sizes as the Vilazodone group. Placebo was given for 19 days. | 0 | 24 | 0 | 24 | 0 | 24 |
|
| Varicocele | Vascular disorders | Systematic Assessment | Not related to the medication or study |
|
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D007211 | Indoles |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |