Trial Outcomes & Findings for Trial of Levomilnacipran in Geriatric Depression (NCT NCT02466958)
NCT ID: NCT02466958
Last Updated: 2019-08-14
Results Overview
This measure includes 24 items. Response options vary item to item and include the following ranges: \[0-2\], \[0-3\], and \[0-4\]. A score of 0 suggests absence of symptoms and/or difficulties and higher scores represent more severe difficulties. Possible overall score range \[0-74\], higher scores representing more severe difficulties.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
29 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2019-08-14
Participant Flow
Participant milestones
| Measure |
Levomilnacipran (FETZIMA)
All eligible subjects will be randomized to levomilnacipran or placebo 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.
levomilnacipran: antidepressant
|
Placebo
All eligible subjects will be randomized to levomilnacipran or placebo 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.
Placebo: an inactive drug
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
12
|
|
Overall Study
COMPLETED
|
7
|
9
|
|
Overall Study
NOT COMPLETED
|
10
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Levomilnacipran in Geriatric Depression
Baseline characteristics by cohort
| Measure |
Levomilnacipran (FETZIMA)
n=17 Participants
All eligible subjects will be randomized to levomilnacipran or placebo 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.
levomilnacipran: antidepressant
|
Placebo
n=12 Participants
All eligible subjects will be randomized to levomilnacipran or placebo 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.
Placebo: an inactive drug
|
Total
n=29 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
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Continuous
|
73.24 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
69.08 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
71.5 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Hamilton Depression Rating Scale Score
|
17.88 units on a scale
STANDARD_DEVIATION 2.5 • n=5 Participants
|
19.92 units on a scale
STANDARD_DEVIATION 2.6 • n=7 Participants
|
18.7 units on a scale
STANDARD_DEVIATION 2.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksThis measure includes 24 items. Response options vary item to item and include the following ranges: \[0-2\], \[0-3\], and \[0-4\]. A score of 0 suggests absence of symptoms and/or difficulties and higher scores represent more severe difficulties. Possible overall score range \[0-74\], higher scores representing more severe difficulties.
Outcome measures
| Measure |
Levomilnacipran (FETZIMA)
n=17 Participants
All eligible subjects will be randomized to levomilnacipran or placebo 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.
levomilnacipran: antidepressant
|
Placebo
n=12 Participants
All eligible subjects will be randomized to levomilnacipran or placebo 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.
Placebo: an inactive drug
|
|---|---|---|
|
Hamilton Depression Rating Scale (HDRS) Scores 24
Baseline
|
17.88 units on a scale
Standard Deviation 2.5
|
19.92 units on a scale
Standard Deviation 2.6
|
|
Hamilton Depression Rating Scale (HDRS) Scores 24
12 Weeks
|
6.86 units on a scale
Standard Deviation 5.7
|
10.33 units on a scale
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: Week 12 reported7-Point Likert Scale \[1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse\].
Outcome measures
| Measure |
Levomilnacipran (FETZIMA)
n=7 Participants
All eligible subjects will be randomized to levomilnacipran or placebo 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.
levomilnacipran: antidepressant
|
Placebo
n=9 Participants
All eligible subjects will be randomized to levomilnacipran or placebo 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.
Placebo: an inactive drug
|
|---|---|---|
|
Clinical Global Impression Scale (CGI) Scores
|
3.00 units on a scale
Standard Deviation .81
|
3.33 units on a scale
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksThe GDS has a total of 30 items with response options \[Yes/No\]. Total score range is \[0-30\]. Higher scores represent more severe difficulties.
Outcome measures
| Measure |
Levomilnacipran (FETZIMA)
n=17 Participants
All eligible subjects will be randomized to levomilnacipran or placebo 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.
levomilnacipran: antidepressant
|
Placebo
n=12 Participants
All eligible subjects will be randomized to levomilnacipran or placebo 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.
Placebo: an inactive drug
|
|---|---|---|
|
Geriatric Depression (GDS) Scores
12 Weeks
|
11.71 units on a scale
Standard Deviation 5.6
|
11.33 units on a scale
Standard Deviation 3.6
|
|
Geriatric Depression (GDS) Scores
Baseline
|
13.5 units on a scale
Standard Deviation 4.0
|
15.33 units on a scale
Standard Deviation 4.8
|
Adverse Events
Levomilnacipran (FETZIMA)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Levomilnacipran (FETZIMA)
n=17 participants at risk
All eligible subjects will be randomized to levomilnacipran or placebo 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.
levomilnacipran: antidepressant
|
Placebo
n=12 participants at risk
All eligible subjects will be randomized to levomilnacipran or placebo 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.
Placebo: an inactive drug
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Teeth grinding
|
17.6%
3/17 • 09/2016 - 07/2018; 1 years and 10 months
|
0.00%
0/12 • 09/2016 - 07/2018; 1 years and 10 months
|
|
Psychiatric disorders
Sleepiness
|
5.9%
1/17 • 09/2016 - 07/2018; 1 years and 10 months
|
0.00%
0/12 • 09/2016 - 07/2018; 1 years and 10 months
|
|
Psychiatric disorders
Decreased duration of sleep
|
11.8%
2/17 • 09/2016 - 07/2018; 1 years and 10 months
|
0.00%
0/12 • 09/2016 - 07/2018; 1 years and 10 months
|
|
General disorders
Reduced salivation
|
11.8%
2/17 • 09/2016 - 07/2018; 1 years and 10 months
|
8.3%
1/12 • 09/2016 - 07/2018; 1 years and 10 months
|
|
General disorders
Sweating
|
5.9%
1/17 • 09/2016 - 07/2018; 1 years and 10 months
|
0.00%
0/12 • 09/2016 - 07/2018; 1 years and 10 months
|
|
Musculoskeletal and connective tissue disorders
Falls
|
5.9%
1/17 • 09/2016 - 07/2018; 1 years and 10 months
|
0.00%
0/12 • 09/2016 - 07/2018; 1 years and 10 months
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • 09/2016 - 07/2018; 1 years and 10 months
|
0.00%
0/12 • 09/2016 - 07/2018; 1 years and 10 months
|
|
Gastrointestinal disorders
Diarrhea
|
5.9%
1/17 • 09/2016 - 07/2018; 1 years and 10 months
|
0.00%
0/12 • 09/2016 - 07/2018; 1 years and 10 months
|
|
Gastrointestinal disorders
Constipation
|
23.5%
4/17 • 09/2016 - 07/2018; 1 years and 10 months
|
0.00%
0/12 • 09/2016 - 07/2018; 1 years and 10 months
|
|
Gastrointestinal disorders
Upset stomach
|
5.9%
1/17 • 09/2016 - 07/2018; 1 years and 10 months
|
0.00%
0/12 • 09/2016 - 07/2018; 1 years and 10 months
|
|
Renal and urinary disorders
Micturition disturbance
|
35.3%
6/17 • 09/2016 - 07/2018; 1 years and 10 months
|
0.00%
0/12 • 09/2016 - 07/2018; 1 years and 10 months
|
|
General disorders
Orthostatic dizziness
|
5.9%
1/17 • 09/2016 - 07/2018; 1 years and 10 months
|
8.3%
1/12 • 09/2016 - 07/2018; 1 years and 10 months
|
|
Reproductive system and breast disorders
Orgastic dysfunction
|
5.9%
1/17 • 09/2016 - 07/2018; 1 years and 10 months
|
0.00%
0/12 • 09/2016 - 07/2018; 1 years and 10 months
|
|
Cardiac disorders
Increased blood pressure
|
5.9%
1/17 • 09/2016 - 07/2018; 1 years and 10 months
|
8.3%
1/12 • 09/2016 - 07/2018; 1 years and 10 months
|
|
Cardiac disorders
Heart palpitations/tachycardia
|
17.6%
3/17 • 09/2016 - 07/2018; 1 years and 10 months
|
0.00%
0/12 • 09/2016 - 07/2018; 1 years and 10 months
|
|
General disorders
Visual disturbances
|
5.9%
1/17 • 09/2016 - 07/2018; 1 years and 10 months
|
0.00%
0/12 • 09/2016 - 07/2018; 1 years and 10 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place