Trial Outcomes & Findings for Vilazodone for Corticosteroid-Induced Memory Impairment (NCT NCT01828515)
NCT ID: NCT01828515
Last Updated: 2019-04-11
Results Overview
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.
COMPLETED
PHASE2
24 participants
Baseline and Day 19
2019-04-11
Participant Flow
24 participants with at least one post-baseline visit were recruited at our research clinic in Dallas, TX and included for analysis.
Healthy control participants without any history of major psychiatric illness, drug/alcohol abuse/dependence, history of neurological disorders, or significant medical conditions were included.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
First Intervention (19 Days)
STARTED
|
13
|
11
|
|
First Intervention (19 Days)
COMPLETED
|
11
|
9
|
|
First Intervention (19 Days)
NOT COMPLETED
|
2
|
2
|
|
Washout (23 Days)
STARTED
|
11
|
9
|
|
Washout (23 Days)
COMPLETED
|
6
|
8
|
|
Washout (23 Days)
NOT COMPLETED
|
5
|
1
|
|
Second Intervention (19 Days)
STARTED
|
6
|
8
|
|
Second Intervention (19 Days)
COMPLETED
|
6
|
5
|
|
Second Intervention (19 Days)
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vilazodone for Corticosteroid-Induced Memory Impairment
Baseline characteristics by cohort
| Measure |
All Study Participants
n=24 Participants
Participants who were randomized to receive either Vilazodone and hydrocortisone or placebo and hydrocortisone.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 19Population: All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis.
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.
Outcome measures
| Measure |
Vilazodone and Hydrocortisone
n=14 Participants
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.
|
Placebo and Hydrocortisone
n=14 Participants
Placebo was given for 19 days and hydrocortisone was given for 4 days.
|
|---|---|---|
|
Change From Baseline RAVLT (Rey Auditory Verbal Learning Test) Total T-Score at Day 19
|
-3 T-score
Standard Deviation 12.48
|
0 T-score
Standard Deviation 7.98
|
Adverse Events
Vilazodone and Hydrocortisone
Placebo and Hydrocortisone
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vilazodone and Hydrocortisone
n=24 participants at risk
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).
|
Placebo and Hydrocortisone
n=24 participants at risk
Placebo group received medication in identical color/sizes as the Vilazodone group. Placebo was given for 19 days.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.2%
1/24 • Number of events 1 • 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.
|
0.00%
0/24 • 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.
|
|
Vascular disorders
Varicocele
|
4.2%
1/24 • Number of events 1 • 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.
|
0.00%
0/24 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60