Trial Outcomes & Findings for Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder (NCT NCT00969150)
NCT ID: NCT00969150
Last Updated: 2013-10-25
Results Overview
MADRS was used to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item of the 10 items are scored on a 7-point scale. A score of 0 indicates the absence of symptoms,and a score of 6 indicates symptoms of maximum severity. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 60 (maximum severity).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
362 participants
Primary outcome timeframe
From Baseline to Week 8
Results posted on
2013-10-25
Participant Flow
Patient were recruited over a 12-month period from September of 2009 to September of 2010 at 24 studies sites in the United States.
Patients went through a 1-week single-blind placebo run-in period immediately preceding an 8-week double-blind treatment period.
Participant milestones
| Measure |
Placebo
Dose Matched placebo capsules, oral administration, once daily dosing for 8 weeks.
|
Levomilnacipran ER
Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
182
|
175
|
|
Overall Study
COMPLETED
|
149
|
135
|
|
Overall Study
NOT COMPLETED
|
33
|
40
|
Reasons for withdrawal
| Measure |
Placebo
Dose Matched placebo capsules, oral administration, once daily dosing for 8 weeks.
|
Levomilnacipran ER
Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
14
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
|
Overall Study
Protocol Violation
|
9
|
12
|
|
Overall Study
Withdrawal by Subject
|
13
|
9
|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
|
Overall Study
Other reasons
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Placebo
n=182 Participants
Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
|
Levomilnacipran ER
n=175 Participants
Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
|
Total
n=357 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
43.7 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
42.8 years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
43.3 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
|
Age, Customized
18 years to 19 years
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Age, Customized
20 years to 29 years
|
33 participants
n=5 Participants
|
34 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Age, Customized
30 years to 39 years
|
35 participants
n=5 Participants
|
32 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Age, Customized
40 years to 49 years
|
47 participants
n=5 Participants
|
53 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Age, Customized
50 years to 59 years
|
40 participants
n=5 Participants
|
37 participants
n=7 Participants
|
77 participants
n=5 Participants
|
|
Age, Customized
60 years to 80 years
|
25 participants
n=5 Participants
|
18 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
215 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
149 participants
n=5 Participants
|
133 participants
n=7 Participants
|
282 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
28 participants
n=5 Participants
|
29 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska native
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
18 participants
n=5 Participants
|
16 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
164 participants
n=5 Participants
|
159 participants
n=7 Participants
|
323 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
182 participants
n=5 Participants
|
175 participants
n=7 Participants
|
357 participants
n=5 Participants
|
|
Weight
|
82.9 kg
STANDARD_DEVIATION 18.0 • n=5 Participants
|
82.4 kg
STANDARD_DEVIATION 18.1 • n=7 Participants
|
82.7 kg
STANDARD_DEVIATION 18.0 • n=5 Participants
|
|
Body Mass Index (BMI)
|
28.9 Kilograms Per Meter Squared
STANDARD_DEVIATION 5.7 • n=5 Participants
|
28.7 Kilograms Per Meter Squared
STANDARD_DEVIATION 5.4 • n=7 Participants
|
28.8 Kilograms Per Meter Squared
STANDARD_DEVIATION 5.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 8Population: Of the 357 patients who received at least 1 dose of double-blind treatment (Safety Population), 355 patients had at least 1 postbaseline MADRS assessment (Intent to Treat \[ITT\] Population).
MADRS was used to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item of the 10 items are scored on a 7-point scale. A score of 0 indicates the absence of symptoms,and a score of 6 indicates symptoms of maximum severity. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 60 (maximum severity).
Outcome measures
| Measure |
Placebo
n=181 Participants
Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
|
Levomilnacipran ER
n=174 Participants
Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
|
|---|---|---|
|
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
|
-14.2 units on a scale
Standard Error 0.90
|
-15.7 units on a scale
Standard Error 0.94
|
SECONDARY outcome
Timeframe: From Baseline to Week 8The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe)
Outcome measures
| Measure |
Placebo
n=181 Participants
Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
|
Levomilnacipran ER
n=174 Participants
Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
|
|---|---|---|
|
Change in Sheehan Disability Scale (SDS) Total Score
|
-8.2 units on a scale
Standard Error 0.67
|
-8.8 units on a scale
Standard Error 0.68
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 58 other events
Deaths: 0 deaths
Levomilnacipran ER
Serious events: 0 serious events
Other events: 90 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=182 participants at risk
Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
|
Levomilnacipran ER
n=175 participants at risk
Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
|
|---|---|---|
|
Investigations
Blood Pressure Increased
|
0.55%
1/182 • Adverse event data was collection over a 14-month period from September 2009 to November 2010 at 24 study sites in the U.S.
The Serious Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
0.00%
0/175 • Adverse event data was collection over a 14-month period from September 2009 to November 2010 at 24 study sites in the U.S.
The Serious Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
|
General disorders
Chest Pain
|
0.55%
1/182 • Adverse event data was collection over a 14-month period from September 2009 to November 2010 at 24 study sites in the U.S.
The Serious Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
0.00%
0/175 • Adverse event data was collection over a 14-month period from September 2009 to November 2010 at 24 study sites in the U.S.
The Serious Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
Other adverse events
| Measure |
Placebo
n=182 participants at risk
Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
|
Levomilnacipran ER
n=175 participants at risk
Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
3.3%
6/182 • Adverse event data was collection over a 14-month period from September 2009 to November 2010 at 24 study sites in the U.S.
The Serious Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
17.1%
30/175 • Adverse event data was collection over a 14-month period from September 2009 to November 2010 at 24 study sites in the U.S.
The Serious Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
|
Nervous system disorders
Headache
|
12.1%
22/182 • Adverse event data was collection over a 14-month period from September 2009 to November 2010 at 24 study sites in the U.S.
The Serious Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
16.0%
28/175 • Adverse event data was collection over a 14-month period from September 2009 to November 2010 at 24 study sites in the U.S.
The Serious Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
|
Gastrointestinal disorders
Dry mouth
|
6.0%
11/182 • Adverse event data was collection over a 14-month period from September 2009 to November 2010 at 24 study sites in the U.S.
The Serious Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
8.0%
14/175 • Adverse event data was collection over a 14-month period from September 2009 to November 2010 at 24 study sites in the U.S.
The Serious Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
0.00%
0/66 • Adverse event data was collection over a 14-month period from September 2009 to November 2010 at 24 study sites in the U.S.
The Serious Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
7.9%
6/76 • Adverse event data was collection over a 14-month period from September 2009 to November 2010 at 24 study sites in the U.S.
The Serious Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
|
Psychiatric disorders
Insomnia
|
7.1%
13/182 • Adverse event data was collection over a 14-month period from September 2009 to November 2010 at 24 study sites in the U.S.
The Serious Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
6.9%
12/175 • Adverse event data was collection over a 14-month period from September 2009 to November 2010 at 24 study sites in the U.S.
The Serious Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.1%
2/182 • Adverse event data was collection over a 14-month period from September 2009 to November 2010 at 24 study sites in the U.S.
The Serious Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
6.9%
12/175 • Adverse event data was collection over a 14-month period from September 2009 to November 2010 at 24 study sites in the U.S.
The Serious Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
|
Nervous system disorders
Dizziness
|
1.6%
3/182 • Adverse event data was collection over a 14-month period from September 2009 to November 2010 at 24 study sites in the U.S.
The Serious Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
6.3%
11/175 • Adverse event data was collection over a 14-month period from September 2009 to November 2010 at 24 study sites in the U.S.
The Serious Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.0%
11/182 • Adverse event data was collection over a 14-month period from September 2009 to November 2010 at 24 study sites in the U.S.
The Serious Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
3.4%
6/175 • Adverse event data was collection over a 14-month period from September 2009 to November 2010 at 24 study sites in the U.S.
The Serious Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
|
Gastrointestinal disorders
Vomiting
|
0.55%
1/182 • Adverse event data was collection over a 14-month period from September 2009 to November 2010 at 24 study sites in the U.S.
The Serious Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
5.7%
10/175 • Adverse event data was collection over a 14-month period from September 2009 to November 2010 at 24 study sites in the U.S.
The Serious Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.5%
1/66 • Adverse event data was collection over a 14-month period from September 2009 to November 2010 at 24 study sites in the U.S.
The Serious Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
5.3%
4/76 • Adverse event data was collection over a 14-month period from September 2009 to November 2010 at 24 study sites in the U.S.
The Serious Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
|
Investigations
Heart rate increased
|
2.2%
4/182 • Adverse event data was collection over a 14-month period from September 2009 to November 2010 at 24 study sites in the U.S.
The Serious Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
5.1%
9/175 • Adverse event data was collection over a 14-month period from September 2009 to November 2010 at 24 study sites in the U.S.
The Serious Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.
|
Additional Information
Carl Gommoll, MS, Sr. Dir. Clinical Development Psychiatry
Forest Research Institute
Phone: 201-427-8000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.
- Publication restrictions are in place
Restriction type: OTHER