Trial Outcomes & Findings for Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Adults With Fatigue Associated With Major Depressive Disorder (NCT NCT01254305)
NCT ID: NCT01254305
Last Updated: 2014-08-06
Results Overview
The CGI-S is a clinician-rated scale that rates the severity of the patient's current state of fatigue based on the Investigator's clinical opinion with regard to the patient population with Major Depressive Disorder (MDD). Patient were rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating that the patient was among the most extremely fatigued
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
262 participants
Primary outcome timeframe
From Baseline to Week 8
Results posted on
2014-08-06
Participant Flow
Patients were recruited over a 12-month period from April of 2011 to April of 2012 at 20 studies sites in the United States.
Patients went through a 1-week single-blind placebo run-in period, followed by an 8-week double-blind treatment period.
Participant milestones
| Measure |
Placebo
Matching placebo capsules, oral administration, once daily dosing.
|
Levomilnacipran ER
40 -120 mg Levomilnacipran ER capsules, oral administration once daily for 8 weeks.
|
SSRI
Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.
Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
93
|
90
|
79
|
|
Overall Study
Safety Population
|
89
|
85
|
77
|
|
Overall Study
COMPLETED
|
71
|
72
|
62
|
|
Overall Study
NOT COMPLETED
|
22
|
18
|
17
|
Reasons for withdrawal
| Measure |
Placebo
Matching placebo capsules, oral administration, once daily dosing.
|
Levomilnacipran ER
40 -120 mg Levomilnacipran ER capsules, oral administration once daily for 8 weeks.
|
SSRI
Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.
Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
3
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
7
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
10
|
6
|
5
|
|
Overall Study
Other Reasons
|
0
|
0
|
2
|
Baseline Characteristics
Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Adults With Fatigue Associated With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Placebo
n=89 Participants
Matching placebo capsules, oral administration
Placebo : Matching placebo capsules, oral administration, once daily dosing
|
Levomilnacipran ER
n=85 Participants
40 - 120 mg Levomilnacipran ER capsules, oral administration, once daily for 8 weeks
|
SSRI
n=77 Participants
Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.
Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks.
|
Total
n=251 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.4 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
42.9 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
42.8 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
42.3 years
STANDARD_DEVIATION 12.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
156 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
62 participants
n=5 Participants
|
57 participants
n=7 Participants
|
47 participants
n=5 Participants
|
166 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
26 participants
n=5 Participants
|
25 participants
n=7 Participants
|
25 participants
n=5 Participants
|
76 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
8 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
22 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
81 participants
n=5 Participants
|
81 participants
n=7 Participants
|
67 participants
n=5 Participants
|
229 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
89 participants
n=5 Participants
|
85 participants
n=7 Participants
|
77 participants
n=5 Participants
|
251 participants
n=4 Participants
|
|
Weight
|
79.95 kg
STANDARD_DEVIATION 15.27 • n=5 Participants
|
82.23 kg
STANDARD_DEVIATION 18.14 • n=7 Participants
|
83.31 kg
STANDARD_DEVIATION 17.61 • n=5 Participants
|
81.75 kg
STANDARD_DEVIATION 17.00 • n=4 Participants
|
|
Body Mass Index (BMI)
|
28.16 Kilograms Per Meter Squared
STANDARD_DEVIATION 4.85 • n=5 Participants
|
28.61 Kilograms Per Meter Squared
STANDARD_DEVIATION 5.22 • n=7 Participants
|
28.80 Kilograms Per Meter Squared
STANDARD_DEVIATION 5.10 • n=5 Participants
|
28.51 Kilograms Per Meter Squared
STANDARD_DEVIATION 5.04 • n=4 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 8Population: The Randomized Population consisted of 262 patients, with 251 patients who took at least 1 dose of double-blind treatment to comprise the Safety population. The Intent-to-Treat (ITT) Population consisted of 248 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of either the CGI-S or PGI-I fatigue score.
The CGI-S is a clinician-rated scale that rates the severity of the patient's current state of fatigue based on the Investigator's clinical opinion with regard to the patient population with Major Depressive Disorder (MDD). Patient were rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating that the patient was among the most extremely fatigued
Outcome measures
| Measure |
Placebo
n=88 Participants
Dose matched placebo, oral administration in capsule form, once daily for 8 weeks
|
Levomilnacipran ER
n=85 Participants
40 - 120 mg Levomilnacipran ER capsules, oral administration in capsule form, once daily for 8 weeks
|
SSRI
n=75 Participants
Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.
Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks.
|
|---|---|---|---|
|
Change in Clinical Global Impression of Severity (CGI-S) for Fatigue Score
|
-1.5 units on a scale
Standard Deviation 1.3
|
-1.8 units on a scale
Standard Deviation 1.4
|
-1.9 units on a scale
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: From Baseline to Week 8Population: The Randomized Population consisted of 262 patients, with 251 patients who took at least 1 dose of double-blind treatment to comprise the Safety population. The Intent-to-Treat (ITT) Population consisted of 248 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of either the CGI-S or PGI-I fatigue score.
The PGI-S is a clinician-rated scale that rates was used to rate the severity of the patient's current state of overall fatigue. Patients were rated on a scale from 1 to 7, with 1 indicating no symptoms of fatigue and 7 indicating extreme fatigue.
Outcome measures
| Measure |
Placebo
n=88 Participants
Dose matched placebo, oral administration in capsule form, once daily for 8 weeks
|
Levomilnacipran ER
n=85 Participants
40 - 120 mg Levomilnacipran ER capsules, oral administration in capsule form, once daily for 8 weeks
|
SSRI
n=75 Participants
Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.
Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks.
|
|---|---|---|---|
|
Change in Patient Global Impressions of Severity (PGI-S) for Fatigue Score
|
-1.4 units on a scale
Standard Deviation 1.5
|
-1.7 units on a scale
Standard Deviation 1.5
|
-1.7 units on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: From Baseline to Week 8Population: The Randomized Population consisted of 262 patients, with 251 patients who took at least 1 dose of double-blind treatment to comprise the Safety population.
The Cognitive and Physical Functioning Questionnaire is a patient-rated, 7-item scale used to measure cognitive and executive dysfunction in mood and anxiety disorders. The CPFQ is sensitive to change with treatment and displays convergent validity by significant correlations with other measures of sleepiness, fatigue, apathy, and neuropsychological functioning. Patients are rated on a scale from 1 to 6 for seven common complaints of depressed patients reporting fatigue or cognitive/executive problems-with 1 indicating greater than normal functioning, 2 indicating normal functioning, and 3 to 6 indicating degrees of impaired functioning. The CPFQ ranges from the best possible score of 7 (greater than normal functioning) to the worst possible score of 42 (totally absent).
Outcome measures
| Measure |
Placebo
n=88 Participants
Dose matched placebo, oral administration in capsule form, once daily for 8 weeks
|
Levomilnacipran ER
n=85 Participants
40 - 120 mg Levomilnacipran ER capsules, oral administration in capsule form, once daily for 8 weeks
|
SSRI
n=75 Participants
Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.
Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks.
|
|---|---|---|---|
|
Change in Cognitive and Physical Functioning Questionnaire (CPFQ), Last Observation Carried Forward
|
-5.9 units on a scale
Standard Deviation 7.9
|
-7.0 units on a scale
Standard Deviation 7.3
|
-6.4 units on a scale
Standard Deviation 7.0
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Levomilnacipran ER
Serious events: 1 serious events
Other events: 41 other events
Deaths: 0 deaths
SSRI
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=89 participants at risk
Matching placebo capsules, oral administration
Placebo : Matching placebo capsules, oral administration, once daily dosing
|
Levomilnacipran ER
n=85 participants at risk
40 -120 mg Levomilnacipran ER capsules, oral administration, once daily for 8 weeks
|
SSRI
n=77 participants at risk
Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.
Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/89 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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.
|
1.2%
1/85 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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%
0/77 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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=89 participants at risk
Matching placebo capsules, oral administration
Placebo : Matching placebo capsules, oral administration, once daily dosing
|
Levomilnacipran ER
n=85 participants at risk
40 -120 mg Levomilnacipran ER capsules, oral administration, once daily for 8 weeks
|
SSRI
n=77 participants at risk
Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.
Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks.
|
|---|---|---|---|
|
General disorders
Nausea
|
4.5%
4/89 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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.
|
16.5%
14/85 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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.
|
7.8%
6/77 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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
|
15.7%
14/89 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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.
|
14.1%
12/85 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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.
|
7.8%
6/77 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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
|
6.7%
6/89 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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.
|
9.4%
8/85 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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.
|
11.7%
9/77 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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
|
2.2%
2/89 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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.
|
7.1%
6/85 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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.
|
1.3%
1/77 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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
|
3.4%
3/89 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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.
|
7.1%
6/85 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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%
0/77 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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
Diarrhoea
|
9.0%
8/89 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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.
|
4.7%
4/85 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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.
|
11.7%
9/77 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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
Somnolence
|
4.5%
4/89 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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.
|
3.5%
3/85 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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.
|
7.8%
6/77 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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
|
1.1%
1/89 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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.
|
2.4%
2/85 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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.
|
6.5%
5/77 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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
Anxiety
|
1.1%
1/89 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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.
|
1.2%
1/85 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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.
|
6.5%
5/77 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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
Initial insomnia
|
1.1%
1/89 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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.
|
1.2%
1/85 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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.
|
6.5%
5/77 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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
|
7.9%
7/89 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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%
0/85 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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.
|
3.9%
3/77 • Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.
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