Trial Outcomes & Findings for Vilazodone for Treatment of Geriatric Depression (NCT NCT01608295)
NCT ID: NCT01608295
Last Updated: 2018-05-11
Results Overview
The HAMD measures the severity of depressive symptoms in participants with major depressive disorder (MDD). It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
65 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2018-05-11
Participant Flow
Single site outpatient clinic in the U.S.
208 volunteers were assessed for eligibility, of which 100 declined to participate and 37 did not meet inclusion criteria. Seventy-one persons consented to participate, of which 65 passed screening and were enrolled; nine of 65 enrolled participants withdrew before randomization.
Participant milestones
| Measure |
Vilazodone; Viibryd
After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.
Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly will have incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety.
|
Paroxetine; Paxil
After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.
Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly will have incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs will be adjusted according to individual tolerability and safety.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
30
|
|
Overall Study
COMPLETED
|
20
|
25
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vilazodone for Treatment of Geriatric Depression
Baseline characteristics by cohort
| Measure |
Vilazodone; Viibryd
n=26 Participants
After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.
Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly will have incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety.
|
Paroxetine; Paxil
n=30 Participants
After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.
Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly will have incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs will be adjusted according to individual tolerability and safety.
|
Total
n=56 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
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Continuous
|
71.5 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
71.5 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
71.5 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
30 participants
n=7 Participants
|
56 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksThe HAMD measures the severity of depressive symptoms in participants with major depressive disorder (MDD). It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms.
Outcome measures
| Measure |
Vilazodone; Viibryd
n=21 Participants
Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly received incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety.
|
Paroxetine; Paxil
n=25 Participants
Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly received incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs were adjusted according to individual tolerability and safety.
|
|---|---|---|
|
Hamilton Depression Rating Scale (HDRS)
HDRS Baseline
|
17.2 units on a scale
Standard Deviation 3.7
|
16.6 units on a scale
Standard Deviation 4.1
|
|
Hamilton Depression Rating Scale (HDRS)
HDRS Final Visit
|
7.6 units on a scale
Standard Deviation 4.8
|
7.5 units on a scale
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: Each visit for 12 weeksNumber of participants with each side-effect event.
Outcome measures
| Measure |
Vilazodone; Viibryd
n=25 Participants
Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly received incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety.
|
Paroxetine; Paxil
n=30 Participants
Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly received incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs were adjusted according to individual tolerability and safety.
|
|---|---|---|
|
UKU Side-effect Profile
Constipation
|
3 participants
|
5 participants
|
|
UKU Side-effect Profile
Concentration Difficulties
|
3 participants
|
0 participants
|
|
UKU Side-effect Profile
Sedation
|
1 participants
|
3 participants
|
|
UKU Side-effect Profile
Increased dream activity
|
3 participants
|
3 participants
|
|
UKU Side-effect Profile
Reduced salivation
|
3 participants
|
1 participants
|
|
UKU Side-effect Profile
Diarrhea
|
3 participants
|
1 participants
|
|
UKU Side-effect Profile
Orthostatic dizziness
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline and Final VisitThe The Rey-Osterrieth Complex Figure Test (REY-O) is a neuropsychological assessment in which measures visual perception and long-term visual memory. Total raw scores range from 0 to 36 with higher scores representing better outcomes in recall. The total raw score represents a sum of subscales scored by 18 individual elements which are scored for both distortion and placement. Two points are awarded to elements that are accurately drawn and properly placed, one point is given to distorted or misplaced elements, 0.5 points are given if an element is both distorted and misplaced, and missing or unrecognizable elements receive zero points.
Outcome measures
| Measure |
Vilazodone; Viibryd
n=20 Participants
Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly received incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety.
|
Paroxetine; Paxil
n=25 Participants
Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly received incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs were adjusted according to individual tolerability and safety.
|
|---|---|---|
|
Neurocognitive Measure: The Rey-Osterrieth Complex Figure Test
REY-O 3 Minute Delay Final Visit
|
15.2 units on a scale
Standard Deviation 7.4
|
16.3 units on a scale
Standard Deviation 4.8
|
|
Neurocognitive Measure: The Rey-Osterrieth Complex Figure Test
REY-O 3 Minute Delay Baseline
|
13.3 units on a scale
Standard Deviation 5.9
|
13.3 units on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: Baseline and Final VisitPopulation: The Arms/Groups are not combined, but results are presented as a ratio of Vilazodone/Paroxetine.
Gene expression data were quantile-normalized and log2-transformed in RNA expression units. The measure included the promoter transcription factor binding motif prevalence ratio of the unit (log2 Vilazodone/Paroxetine) and ranging from a minimum of -3 to a maximum of 3 with higher scores indicating better outcomes.
Outcome measures
| Measure |
Vilazodone; Viibryd
n=46 Participants
Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly received incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety.
|
Paroxetine; Paxil
Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly received incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs were adjusted according to individual tolerability and safety.
|
|---|---|---|
|
Changes in Proinflammatory Gene Expression From Baseline to Final Visit (up to 12 Weeks)
AP-1, Activator Protein
|
-0.8 RNA expression units
Standard Error 0.5
|
—
|
|
Changes in Proinflammatory Gene Expression From Baseline to Final Visit (up to 12 Weeks)
NF-kB, Nuclear Factor Kappa B
|
-1.25 RNA expression units
Standard Error 0.5
|
—
|
|
Changes in Proinflammatory Gene Expression From Baseline to Final Visit (up to 12 Weeks)
GR, Glucocorticoid Receptor
|
0.2 RNA expression units
Standard Error 0.6
|
—
|
|
Changes in Proinflammatory Gene Expression From Baseline to Final Visit (up to 12 Weeks)
CREB, cAMP response element binding protein
|
-2.1 RNA expression units
Standard Error 0.7
|
—
|
Adverse Events
Vilazodone; Viibryd
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Paroxetine; Paxil
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vilazodone; Viibryd
n=26 participants at risk
Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly received incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety.
|
Paroxetine; Paxil
n=30 participants at risk
Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly received incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs were adjusted according to individual tolerability and safety.
|
|---|---|---|
|
Gastrointestinal disorders
Reduced salivation
|
11.5%
3/26
|
3.3%
1/30
|
|
Psychiatric disorders
Concentration Difficulties
|
11.5%
3/26
|
0.00%
0/30
|
|
Nervous system disorders
Sedation
|
3.8%
1/26
|
10.0%
3/30
|
|
Nervous system disorders
Increased Dream Activity
|
11.5%
3/26
|
10.0%
3/30
|
|
Gastrointestinal disorders
Diarrhea
|
11.5%
3/26
|
3.3%
1/30
|
|
Gastrointestinal disorders
Constipation
|
11.5%
3/26
|
16.7%
5/30
|
|
Vascular disorders
Orthostatic dizziness
|
11.5%
3/26
|
10.0%
3/30
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place