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

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ClinicalTrials.gov Identifier: NCT00969150
Recruitment Status : Completed
First Posted : September 1, 2009
Results First Posted : October 25, 2013
Last Update Posted : October 25, 2013
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: Levomilnacipran ER
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patient were recruited over a 12-month period from September of 2009 to September of 2010 at 24 studies sites in the United States.

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

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Placebo   Levomilnacipran ER
STARTED   182   175 
COMPLETED   149   135 
NOT COMPLETED   33   40 
Adverse Event                4                14 
Lack of Efficacy                1                1 
Protocol Violation                9                12 
Withdrawal by Subject                13                9 
Lost to Follow-up                5                4 
Other reasons                1                0 



  Baseline Characteristics

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.
While a total of 362 patients were randomized to receive double-blind treatment, 5 of these patients were either lost to follow up or withdrew consent before receiving double-blind treatment. The Baseline Participant population is based on the 357 randomized patients who went on to receive double-blind treatment (Safety Population).

Reporting Groups
  Description
Placebo Matching 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.
Total Total of all reporting groups

Baseline Measures
   Placebo   Levomilnacipran ER   Total 
Overall Participants Analyzed 
[Units: Participants]
 182   175   357 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.7  (13.3)   42.8  (12.9)   43.3  (13.1) 
Age, Customized 
[Units: Participants]
     
18 years to 19 years   2   1   3 
20 years to 29 years   33   34   67 
30 years to 39 years   35   32   67 
40 years to 49 years   47   53   100 
50 years to 59 years   40   37   77 
60 years to 80 years   25   18   43 
Gender 
[Units: Participants]
     
Female   116   99   215 
Male   66   76   142 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   149   133   282 
Black or African American   28   29   57 
Asian   3   4   7 
American Indian or Alaska native   0   3   3 
Other   2   6   8 
Hispanic or Latino   18   16   34 
Not Hispanic or Latino   164   159   323 
Region of Enrollment 
[Units: Participants]
     
United States   182   175   357 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 82.9  (18.0)   82.4  (18.1)   82.7  (18.0) 
Body Mass Index (BMI) 
[Units: Kilograms Per Meter Squared]
Mean (Standard Deviation)
 28.9  (5.7)   28.7  (5.4)   28.8  (5.5) 


  Outcome Measures

1.  Primary:   Change in Montgomery-Asberg 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

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
No text entered.


  More Information

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: NCT00969150     History of Changes
Other Study ID Numbers: LVM-MD-02
First Submitted: August 31, 2009
First Posted: September 1, 2009
Results First Submitted: August 22, 2013
Results First Posted: October 25, 2013
Last Update Posted: October 25, 2013