Trial Outcomes & Findings for Safety and Efficacy of Levomilnacipran ER in Adolescent Participants With Major Depressive Disorder (NCT NCT02431806)
NCT ID: NCT02431806
Last Updated: 2020-09-07
Results Overview
CDRS-R is a 17-item scale measuring presence and severity of symptoms commonly associated with childhood depression and is scored on a 1-to-5- or 1-to-7-point scale. Rating of 1 indicates normal function. The CDRS-R total score ranges from 17 to 113; higher score indicates more severe depression. A negative change from Baseline indicates improvement. Mixed Model for Repeated Measures (MMRM) was used for analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
552 participants
Primary outcome timeframe
Baseline (Week 0) to Week 8
Results posted on
2020-09-07
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received 2 dose matched over-encapsulated placebo capsules, once daily, orally during the Double-blind Treatment Period up to 8 weeks followed by a 1 week Taper-down Period if applicable as determined by the investigator.
|
Levomilnacipran 40 mg/Day
Participants received over-encapsulated levomilnacipran extended release (ER) 40 mg/day capsules orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Days 3-7 and 40 mg/day on Week 2 through Week 8 during the Double-Blind Treatment Period, followed by a 1-week Double-Blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
|
Levomilnacipran 80 mg/Day
Participants received over-encapsulated levomilnacipran ER two 40 mg/day capsules (80 mg/day) orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Day 3-4, 40 mg/day on Day 5-7 and 80 mg/day on Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule the first week and during the taper-down period to maintain the blind.
|
Fluoxetine 20 mg/Day
Participants received over-encapsulated fluoxetine 20 mg/day tablets orally starting at a dose of 10 mg/day in Week 1 and 20 mg/day in Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
|
|---|---|---|---|---|
|
Double-blind Treatment Period
STARTED
|
142
|
136
|
139
|
135
|
|
Double-blind Treatment Period
Safety Population
|
141
|
134
|
138
|
134
|
|
Double-blind Treatment Period
COMPLETED
|
117
|
115
|
107
|
109
|
|
Double-blind Treatment Period
NOT COMPLETED
|
25
|
21
|
32
|
26
|
|
Double-blind Down-taper Period
STARTED
|
111
|
109
|
104
|
107
|
|
Double-blind Down-taper Period
COMPLETED
|
111
|
109
|
104
|
107
|
|
Double-blind Down-taper Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Participants received 2 dose matched over-encapsulated placebo capsules, once daily, orally during the Double-blind Treatment Period up to 8 weeks followed by a 1 week Taper-down Period if applicable as determined by the investigator.
|
Levomilnacipran 40 mg/Day
Participants received over-encapsulated levomilnacipran extended release (ER) 40 mg/day capsules orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Days 3-7 and 40 mg/day on Week 2 through Week 8 during the Double-Blind Treatment Period, followed by a 1-week Double-Blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
|
Levomilnacipran 80 mg/Day
Participants received over-encapsulated levomilnacipran ER two 40 mg/day capsules (80 mg/day) orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Day 3-4, 40 mg/day on Day 5-7 and 80 mg/day on Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule the first week and during the taper-down period to maintain the blind.
|
Fluoxetine 20 mg/Day
Participants received over-encapsulated fluoxetine 20 mg/day tablets orally starting at a dose of 10 mg/day in Week 1 and 20 mg/day in Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
|
|---|---|---|---|---|
|
Double-blind Treatment Period
Did not Receive Treatment
|
1
|
2
|
1
|
1
|
|
Double-blind Treatment Period
Adverse Event
|
4
|
7
|
11
|
7
|
|
Double-blind Treatment Period
Lack of Efficacy
|
2
|
0
|
2
|
2
|
|
Double-blind Treatment Period
Withdrawal of Consent
|
10
|
7
|
5
|
5
|
|
Double-blind Treatment Period
Lost to Follow-up
|
7
|
4
|
5
|
8
|
|
Double-blind Treatment Period
Investigational Product Non-compliance
|
1
|
0
|
3
|
1
|
|
Double-blind Treatment Period
Reason Not Specified
|
0
|
1
|
5
|
2
|
Baseline Characteristics
Intent to Treat (ITT) Population included all participants in the Safety Population who had the baseline and at least 1 postbaseline assessment of the CDRS-R total score.
Baseline characteristics by cohort
| Measure |
Placebo
n=141 Participants
Participants received 2 dose matched over-encapsulated placebo capsules, once daily, orally during the Double-blind Treatment Period up to 8 weeks followed by a 1 week Taper-down Period if applicable as determined by the investigator.
|
Levomilnacipran 40 mg/Day
n=134 Participants
Participants received over-encapsulated levomilnacipran extended release (ER) 40 mg/day capsules orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Days 3-7 and 40 mg/day on Week 2 through Week 8 during the Double-Blind Treatment Period, followed by a 1-week Double-Blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
|
Levomilnacipran 80 mg/Day
n=138 Participants
Participants received over-encapsulated levomilnacipran ER two 40 mg/day capsules (80 mg/day) orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Day 3-4, 40 mg/day on Day 5-7 and 80 mg/day on Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule the first week and during the taper-down period to maintain the blind.
|
Fluoxetine 20 mg/Day
n=134 Participants
Participants received over-encapsulated fluoxetine 20 mg/day tablets orally starting at a dose of 10 mg/day in Week 1 and 20 mg/day in Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
|
Total
n=547 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
14.3 years
STANDARD_DEVIATION 1.59 • n=141 Participants
|
14.8 years
STANDARD_DEVIATION 1.62 • n=134 Participants
|
14.8 years
STANDARD_DEVIATION 1.75 • n=138 Participants
|
14.7 years
STANDARD_DEVIATION 1.67 • n=134 Participants
|
14.7 years
STANDARD_DEVIATION 1.67 • n=547 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=141 Participants
|
94 Participants
n=134 Participants
|
87 Participants
n=138 Participants
|
84 Participants
n=134 Participants
|
363 Participants
n=547 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=141 Participants
|
40 Participants
n=134 Participants
|
51 Participants
n=138 Participants
|
50 Participants
n=134 Participants
|
184 Participants
n=547 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
33 Participants
n=141 Participants
|
36 Participants
n=134 Participants
|
32 Participants
n=138 Participants
|
36 Participants
n=134 Participants
|
137 Participants
n=547 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
108 Participants
n=141 Participants
|
98 Participants
n=134 Participants
|
106 Participants
n=138 Participants
|
98 Participants
n=134 Participants
|
410 Participants
n=547 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=141 Participants
|
0 Participants
n=134 Participants
|
0 Participants
n=138 Participants
|
0 Participants
n=134 Participants
|
0 Participants
n=547 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=141 Participants
|
0 Participants
n=134 Participants
|
1 Participants
n=138 Participants
|
1 Participants
n=134 Participants
|
3 Participants
n=547 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=141 Participants
|
1 Participants
n=134 Participants
|
1 Participants
n=138 Participants
|
1 Participants
n=134 Participants
|
4 Participants
n=547 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=141 Participants
|
1 Participants
n=134 Participants
|
0 Participants
n=138 Participants
|
0 Participants
n=134 Participants
|
1 Participants
n=547 Participants
|
|
Race (NIH/OMB)
Black or African American
|
52 Participants
n=141 Participants
|
46 Participants
n=134 Participants
|
49 Participants
n=138 Participants
|
40 Participants
n=134 Participants
|
187 Participants
n=547 Participants
|
|
Race (NIH/OMB)
White
|
81 Participants
n=141 Participants
|
81 Participants
n=134 Participants
|
83 Participants
n=138 Participants
|
88 Participants
n=134 Participants
|
333 Participants
n=547 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=141 Participants
|
4 Participants
n=134 Participants
|
3 Participants
n=138 Participants
|
4 Participants
n=134 Participants
|
17 Participants
n=547 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=141 Participants
|
1 Participants
n=134 Participants
|
1 Participants
n=138 Participants
|
0 Participants
n=134 Participants
|
2 Participants
n=547 Participants
|
|
Children's Depression Rating Scale-Revised (CDRS-R) Total Score
|
61.1 score on a scale
n=140 Participants • Intent to Treat (ITT) Population included all participants in the Safety Population who had the baseline and at least 1 postbaseline assessment of the CDRS-R total score.
|
61.8 score on a scale
n=134 Participants • Intent to Treat (ITT) Population included all participants in the Safety Population who had the baseline and at least 1 postbaseline assessment of the CDRS-R total score.
|
59.4 score on a scale
n=138 Participants • Intent to Treat (ITT) Population included all participants in the Safety Population who had the baseline and at least 1 postbaseline assessment of the CDRS-R total score.
|
61.5 score on a scale
n=134 Participants • Intent to Treat (ITT) Population included all participants in the Safety Population who had the baseline and at least 1 postbaseline assessment of the CDRS-R total score.
|
60.95 score on a scale
n=546 Participants • Intent to Treat (ITT) Population included all participants in the Safety Population who had the baseline and at least 1 postbaseline assessment of the CDRS-R total score.
|
|
Clinical Global Impression-Severity (CGI-S) Scale
|
4.7 score on a scale
n=140 Participants • ITT Population included all participants in the Safety Population who had the baseline and at least 1 postbaseline assessment of the CDRS-R total score. Overall number of participants analyzed is the number of participants with data available for analyses.
|
4.8 score on a scale
n=134 Participants • ITT Population included all participants in the Safety Population who had the baseline and at least 1 postbaseline assessment of the CDRS-R total score. Overall number of participants analyzed is the number of participants with data available for analyses.
|
4.7 score on a scale
n=138 Participants • ITT Population included all participants in the Safety Population who had the baseline and at least 1 postbaseline assessment of the CDRS-R total score. Overall number of participants analyzed is the number of participants with data available for analyses.
|
4.7 score on a scale
n=134 Participants • ITT Population included all participants in the Safety Population who had the baseline and at least 1 postbaseline assessment of the CDRS-R total score. Overall number of participants analyzed is the number of participants with data available for analyses.
|
4.7 score on a scale
n=546 Participants • ITT Population included all participants in the Safety Population who had the baseline and at least 1 postbaseline assessment of the CDRS-R total score. Overall number of participants analyzed is the number of participants with data available for analyses.
|
PRIMARY outcome
Timeframe: Baseline (Week 0) to Week 8Population: ITT Population included all participants in the Safety Population who had the baseline and at least 1 postbaseline assessment of the CDRS-R total score. Overall number of participants analyzed is the number of participants with data available for analyses.
CDRS-R is a 17-item scale measuring presence and severity of symptoms commonly associated with childhood depression and is scored on a 1-to-5- or 1-to-7-point scale. Rating of 1 indicates normal function. The CDRS-R total score ranges from 17 to 113; higher score indicates more severe depression. A negative change from Baseline indicates improvement. Mixed Model for Repeated Measures (MMRM) was used for analysis.
Outcome measures
| Measure |
Placebo
n=118 Participants
Participants received 2 dose matched over-encapsulated placebo capsules, once daily, orally during the Double-blind Treatment Period up to 8 weeks followed by a 1 week Taper-down Period if applicable as determined by the investigator.
|
Levomilnacipran 40 mg/Day
n=115 Participants
Participants received over-encapsulated levomilnacipran extended release (ER) 40 mg/day capsules orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Days 3-7 and 40 mg/day on Week 2 through Week 8 during the Double-Blind Treatment Period, followed by a 1-week Double-Blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
|
Levomilnacipran 80 mg/Day
n=110 Participants
Participants received over-encapsulated levomilnacipran ER two 40 mg/day capsules (80 mg/day) orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Day 3-4, 40 mg/day on Day 5-7 and 80 mg/day on Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule the first week and during the taper-down period to maintain the blind.
|
Fluoxetine 20 mg/Day
n=112 Participants
Participants received over-encapsulated fluoxetine 20 mg/day tablets orally starting at a dose of 10 mg/day in Week 1 and 20 mg/day in Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
|
|---|---|---|---|---|
|
Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score
|
-22.90 score on a scale
Standard Error 1.09
|
-23.28 score on a scale
Standard Error 1.11
|
-22.64 score on a scale
Standard Error 1.12
|
-24.37 score on a scale
Standard Error 1.12
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 8Population: ITT Population included all participants in the Safety Population who had the baseline and at least 1 postbaseline assessment of the Children's Depression Rating Scale-Revised (CDRS-R) total score. Overall number of participants analyzed is the number of participants with data available for analyses.
The CGI-S is a clinician-rated scale used to rate the severity of the participants current state of mental illness compared with MDD population. The participant was rated on a scale from 1 to 7, where 1= Very much improved; 2= Much improved; 3= Minimally improved; 4= No change; 5= Minimally worse; 6= Much worse; 7= Very much worse. Higher score indicates worsening of mental illness. A negative change from Baseline indicates improvement. MMRM was used for analysis.
Outcome measures
| Measure |
Placebo
n=118 Participants
Participants received 2 dose matched over-encapsulated placebo capsules, once daily, orally during the Double-blind Treatment Period up to 8 weeks followed by a 1 week Taper-down Period if applicable as determined by the investigator.
|
Levomilnacipran 40 mg/Day
n=115 Participants
Participants received over-encapsulated levomilnacipran extended release (ER) 40 mg/day capsules orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Days 3-7 and 40 mg/day on Week 2 through Week 8 during the Double-Blind Treatment Period, followed by a 1-week Double-Blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
|
Levomilnacipran 80 mg/Day
n=110 Participants
Participants received over-encapsulated levomilnacipran ER two 40 mg/day capsules (80 mg/day) orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Day 3-4, 40 mg/day on Day 5-7 and 80 mg/day on Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule the first week and during the taper-down period to maintain the blind.
|
Fluoxetine 20 mg/Day
n=112 Participants
Participants received over-encapsulated fluoxetine 20 mg/day tablets orally starting at a dose of 10 mg/day in Week 1 and 20 mg/day in Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
|
|---|---|---|---|---|
|
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale
|
-1.54 score on a scale
Standard Error 0.10
|
-1.52 score on a scale
Standard Error 0.10
|
-1.52 score on a scale
Standard Error 0.10
|
-1.68 score on a scale
Standard Error 0.10
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Levomilnacipran 40 mg/Day
Serious events: 2 serious events
Other events: 54 other events
Deaths: 0 deaths
Levomilnacipran 80 mg/Day
Serious events: 0 serious events
Other events: 63 other events
Deaths: 0 deaths
Fluoxetine 20 mg/Day
Serious events: 4 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=141 participants at risk
Participants received 2 dose matched over-encapsulated placebo capsules, once daily, orally during the Double-blind Treatment Period up to 8 weeks followed by a 1 week Taper-down Period if applicable as determined by the investigator.
|
Levomilnacipran 40 mg/Day
n=134 participants at risk
Participants received over-encapsulated levomilnacipran extended release (ER) 40 mg/day capsules orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Days 3-7 and 40 mg/day on Week 2 through Week 8 during the Double-Blind Treatment Period, followed by a 1-week Double-Blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
|
Levomilnacipran 80 mg/Day
n=138 participants at risk
Participants received over-encapsulated levomilnacipran ER two 40 mg/day capsules (80 mg/day) orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Day 3-4, 40 mg/day on Day 5-7 and 80 mg/day on Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule the first week and during the taper-down period to maintain the blind.
|
Fluoxetine 20 mg/Day
n=134 participants at risk
Participants received over-encapsulated fluoxetine 20 mg/day tablets orally starting at a dose of 10 mg/day in Week 1 and 20 mg/day in Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/141 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
0.75%
1/134 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
0.00%
0/138 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
0.00%
0/134 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/141 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
0.00%
0/134 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
0.00%
0/138 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
0.75%
1/134 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/141 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
0.75%
1/134 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
0.00%
0/138 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
0.75%
1/134 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/141 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
0.00%
0/134 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
0.00%
0/138 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
0.75%
1/134 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/141 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
0.00%
0/134 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
0.00%
0/138 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
0.75%
1/134 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
Other adverse events
| Measure |
Placebo
n=141 participants at risk
Participants received 2 dose matched over-encapsulated placebo capsules, once daily, orally during the Double-blind Treatment Period up to 8 weeks followed by a 1 week Taper-down Period if applicable as determined by the investigator.
|
Levomilnacipran 40 mg/Day
n=134 participants at risk
Participants received over-encapsulated levomilnacipran extended release (ER) 40 mg/day capsules orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Days 3-7 and 40 mg/day on Week 2 through Week 8 during the Double-Blind Treatment Period, followed by a 1-week Double-Blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
|
Levomilnacipran 80 mg/Day
n=138 participants at risk
Participants received over-encapsulated levomilnacipran ER two 40 mg/day capsules (80 mg/day) orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Day 3-4, 40 mg/day on Day 5-7 and 80 mg/day on Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule the first week and during the taper-down period to maintain the blind.
|
Fluoxetine 20 mg/Day
n=134 participants at risk
Participants received over-encapsulated fluoxetine 20 mg/day tablets orally starting at a dose of 10 mg/day in Week 1 and 20 mg/day in Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
|
|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.71%
1/141 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
9.7%
13/134 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
8.7%
12/138 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
3.7%
5/134 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
|
Gastrointestinal disorders
Nausea
|
5.7%
8/141 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
14.2%
19/134 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
15.9%
22/138 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
3.7%
5/134 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.8%
4/141 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
4.5%
6/134 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
5.1%
7/138 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
3.0%
4/134 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
3/141 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
8.2%
11/134 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
8.0%
11/138 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
3.0%
4/134 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
|
Infections and infestations
Nasopharyngitis
|
2.1%
3/141 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
3.0%
4/134 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
5.1%
7/138 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
5.2%
7/134 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.4%
2/141 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
5.2%
7/134 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
6.5%
9/138 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
7.5%
10/134 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
|
Nervous system disorders
Headache
|
10.6%
15/141 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
14.9%
20/134 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
13.8%
19/138 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
9.7%
13/134 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
|
Nervous system disorders
Dizziness
|
3.5%
5/141 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
3.7%
5/134 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
6.5%
9/138 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
2.2%
3/134 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
|
Nervous system disorders
Somnolence
|
2.1%
3/141 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
4.5%
6/134 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
5.8%
8/138 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
1.5%
2/134 • First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER