Trial Outcomes & Findings for Double-Blind Treatment of Major Depressive Disorder With Vilazodone (NCT NCT01742832)
NCT ID: NCT01742832
Last Updated: 2023-02-23
Results Overview
The entire study will last 18 weeks. For the first 6 weeks, subjects will come in once every 2 weeks. For the next 4 weeks, subjects will come in once per week. For the next 6 weeks, subjects will come in once every 2 weeks. The final visit will come 2 weeks later for a total of 11 visits where the MADRS will be administered. Only the baseline and final (last observation) assessments for the outcome measure was used in determining results, thus these are the only values included. MADRS scores range from 0-60, with higher scores indicating a greater level of severity. No subscales were used.
COMPLETED
PHASE2
79 participants
Baseline and final MADRS scores during the double-blind phase.
2023-02-23
Participant Flow
The Enrollment number in the Protocol Section (79) conflicts with the number of participants Started in the Participant Flow module (48) because the assessment of interested was the double-blind portion of the study. Only 48 subjects were enrolled in this phase of the study, while 79 were enrolled in the preliminary open-label phase.
The results reported are for the double-blind phase, not the open label citalopram phase of the study.
Participant milestones
| Measure |
Vilazodone
A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.
Vilazodone: A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.
|
Citalopram
For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.
Citalopram: For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
28
|
|
Overall Study
COMPLETED
|
19
|
23
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Double-Blind Treatment of Major Depressive Disorder With Vilazodone
Baseline characteristics by cohort
| Measure |
Vilazodone
n=19 Participants
A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.
Vilazodone: A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.
|
Citalopram
n=23 Participants
For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.
Citalopram: For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
31.7 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
38.6 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
35.4 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and final MADRS scores during the double-blind phase.The entire study will last 18 weeks. For the first 6 weeks, subjects will come in once every 2 weeks. For the next 4 weeks, subjects will come in once per week. For the next 6 weeks, subjects will come in once every 2 weeks. The final visit will come 2 weeks later for a total of 11 visits where the MADRS will be administered. Only the baseline and final (last observation) assessments for the outcome measure was used in determining results, thus these are the only values included. MADRS scores range from 0-60, with higher scores indicating a greater level of severity. No subscales were used.
Outcome measures
| Measure |
Vilazodone
n=19 Participants
A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.
Vilazodone: A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.
|
Citalopram
n=23 Participants
For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.
Citalopram: For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.
|
|---|---|---|
|
Montgomery-Åsberg Depression Rating Scale (MADRS)
First Randomized Visit (Visit 8)
|
13.9 units on a scale
Standard Deviation 5.3
|
12.7 units on a scale
Standard Deviation 8.4
|
|
Montgomery-Åsberg Depression Rating Scale (MADRS)
Second Randomized Visit (Visit 9)
|
14.5 units on a scale
Standard Deviation 4.4
|
13.2 units on a scale
Standard Deviation 8.5
|
|
Montgomery-Åsberg Depression Rating Scale (MADRS)
Third Randomized Visit (Visit 10)
|
13.9 units on a scale
Standard Deviation 5.1
|
13.5 units on a scale
Standard Deviation 8.5
|
|
Montgomery-Åsberg Depression Rating Scale (MADRS)
Fourth Randomized Visit (Visit 11)
|
13.9 units on a scale
Standard Deviation 5.3
|
12.7 units on a scale
Standard Deviation 8.4
|
Adverse Events
Vilazodone
Citalopram
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vilazodone
n=19 participants at risk
A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.
Vilazodone: A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.
|
Citalopram
n=23 participants at risk
For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.
Citalopram: For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/19 • The adverse events reported were during the double-blind phase of the study
|
4.3%
1/23 • The adverse events reported were during the double-blind phase of the study
|
|
General disorders
Dry Mouth
|
5.3%
1/19 • The adverse events reported were during the double-blind phase of the study
|
0.00%
0/23 • The adverse events reported were during the double-blind phase of the study
|
|
Gastrointestinal disorders
Diarrhea
|
5.3%
1/19 • The adverse events reported were during the double-blind phase of the study
|
0.00%
0/23 • The adverse events reported were during the double-blind phase of the study
|
|
General disorders
Sexual side effects
|
5.3%
1/19 • The adverse events reported were during the double-blind phase of the study
|
0.00%
0/23 • The adverse events reported were during the double-blind phase of the study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place