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Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00969709
First received: August 31, 2009
Last updated: August 22, 2013
Last verified: August 2013
Results First Received: August 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: Levomilnacipran ER
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patient recruitment at 38 study centers located in the United States during a 17 month period from September 2009 to February 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study included a 1-week, single-blind placebo run-in period immediately before the 8-week double-blind treatment period.

Reporting Groups
  Description
Placebo

Dose matching placebo capsules, oral administration, once daily dosing.

Placebo : Matching placebo capsules, oral administration, once daily for 8 weeks.

Levomilnacipran ER 40 mg

40 mg/day Levomilnacipran ER capsules, low dose, oral administration, once daily dosing.

Levomilnacipran ER, low dose, oral administration, in capsule form, once daily for 8 weeks.

Levomilnacipran ER 80 mg

80 mg/day Levomilnacipran ER capsules, medium dose, oral administration, once daily dosing

Levomilnacipran ER, medium dose, oral administration, in capsule form, once daily for 8 weeks.

Levomilnacipran ER 120 mg

120 mg/day Levomilnacipran ER capsules, high dose, oral administration, once daily dosing

Levomilnacipran ER, high dose, oral administration, in capsule form, once daily for 8 weeks.


Participant Flow:   Overall Study
    Placebo   Levomilnacipran ER 40 mg   Levomilnacipran ER 80 mg   Levomilnacipran ER 120 mg
STARTED   176   178   179   180 
COMPLETED   138   130   121   117 
NOT COMPLETED   38   48   58   63 
Adverse Event                3                13                26                12 
Lack of Efficacy                7                4                1                3 
Protocol Violation                9                5                9                10 
Withdrawal by Subject                9                12                11                23 
Lost to Follow-up                10                14                8                15 
Other reasons                0                0                3                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
A total of 724 patients were randomized to receive double-blind treatment (Randomized Population); 713 patients received at least 1 dose of treatment (Safety Population). The demographic analyses of the baseline participants is based on the Safety Population

Reporting Groups
  Description
Placebo Dose matching placebo capsules, oral administration, once daily dosing for 8 weeks
Levomilnacipran ER 40 mg 40 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
Levomilnacipran ER 80 mg 80 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
Levomilnacipran ER 120 mg 120 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo   Levomilnacipran ER 40 mg   Levomilnacipran ER 80 mg   Levomilnacipran ER 120 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 176   178   179   180   713 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.1  (11.3)   41.6  (13.1)   41.0  (12.8)   40.3  (11.9)   41.1  (12.3) 
Age, Customized 
[Units: Participants]
         
18 years to 19 years   1   2   4   2   9 
20 years to 29 years   31   43   44   42   160 
30 years to 39 years   47   34   33   38   152 
40 years to 49 years   44   36   48   46   174 
50 years to 59 years   46   48   36   41   171 
60 years to 65 years   7   15   14   11   47 
Gender 
[Units: Participants]
         
Female   108   122   111   106   447 
Male   68   56   68   74   266 
Race/Ethnicity, Customized 
[Units: Participants]
         
White   134   133   129   130   526 
Black or African American   29   36   39   41   145 
Asian   8   3   5   3   19 
American Indian or Alaska native   1   0   2   1   4 
Native Hawaiian or other Pacific Islander   0   0   0   1   1 
Other   3   6   4   4   17 
Hispanic or Latino   20   22   28   22   92 
Not Hispanic or Latino   156   155   151   158   620 
Region of Enrollment 
[Units: Participants]
         
United States   176   178   179   180   713 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 83.8  (19.3)   79.5  (17.1)   83.0  (17.3)   84.2  (18.6)   82.6  (18.1) 
Body Mass Index (BMI) 
[Units: Kilograms Per Meter Squared]
Mean (Standard Deviation)
 29.0  (5.8)   28.0  (5.3)   28.9  (5.4)   29.2  (5.4)   28.8  (5.5) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score   [ Time Frame: From Baseline to Week 8 ]

2.  Secondary:   Change in Sheehan Disability Scale (SDS) Total Score   [ Time Frame: From Baseline to Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only 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 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Carl Gommoll, MS, Sr. Dir. Clinical Development Psychiatry
Organization: Forest Research Institute
phone: 201-427-8000 ext 8124
e-mail: carl.gommoll@frx.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00969709     History of Changes
Other Study ID Numbers: LVM-MD-01
Study First Received: August 31, 2009
Results First Received: August 22, 2013
Last Updated: August 22, 2013
Health Authority: United States: Food and Drug Administration