ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 15 of 1724 for:    depression AND Major Depression AND Scale | "Depression"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01377194
Recruitment Status : Completed
First Posted : June 21, 2011
Results First Posted : October 29, 2013
Last Update Posted : October 29, 2013
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, 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 recruitment occurred during a 6 month period from June to December 2011 at 47 study sites in the United States and 4 study sites in Canada.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All patients went through a 1-week single-blind placebo run-in period before randomization.

Reporting Groups
  Description
Placebo Dose matched placebo, oral administration in capsule form, once daily for 8 weeks.
Levomilnacipran ER 40 mg 40mg of Levomilnacipran ER, oral administration in capsule form, once daily, for 8 weeks
Levomilnacipran ER 80 mg 80mg of Levomilnacipran ER, oral administration in capsule form, once daily, for 8 weeks

Participant Flow:   Overall Study
    Placebo   Levomilnacipran ER 40 mg   Levomilnacipran ER 80 mg
STARTED   186   188   188 
COMPLETED   154   145   142 
NOT COMPLETED   32   43   46 
Adverse Event                3                12                19 
Lack of Efficacy                3                3                3 
Protocol Violation                4                10                6 
Withdrawal by Subject                8                10                7 
Lost to Follow-up                14                8                11 



  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.
The Baseline Participant population is based on the 562 randomized patients who went on to receive double-blind treatment (Safety Population).

Reporting Groups
  Description
Placebo Dose matched placebo, oral administration in capsule form, once daily for 8 weeks.
Levomilnacipran ER 40 mg 40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks.
Levomilnacipran 80 mg 40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo   Levomilnacipran ER 40 mg   Levomilnacipran 80 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 186   188   188   562 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.3  (13.2)   42.9  (13.4)   43.1  (12.8)   42.8  (13.1) 
Age, Customized 
[Units: Participants]
       
< 20   3   1   5   9 
≥ 20-29   35   35   28   98 
≥ 30-39   43   40   44   127 
≥ 40-49   45   49   53   147 
≥ 50-59   43   42   36   121 
≥ 60   17   21   22   60 
Gender 
[Units: Participants]
       
Female   116   117   124   357 
Male   70   71   64   205 
Race/Ethnicity, Customized 
[Units: Participants]
       
White   135   142   139   416 
Black or African-American   35   37   36   108 
Asian   7   4   3   14 
American Indian of Alaska Native   3   0   0   3 
Native Hawaiian or other Pacific Islander   1   0   0   1 
Other Race   5   5   10   20 
Hispanic   23   24   15   62 
Non-Hispanic   163   164   173   500 
Region of Enrollment 
[Units: Participants]
       
United States   177   183   180   540 
Canada   9   5   8   22 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 81.60  (17.77)   81.35  (17.09)   81.73  (17.57)   81.56  (17.45) 
Height 
[Units: Cm]
Mean (Standard Deviation)
 168.41  (9.69)   169.48  (9.79)   168.63  (8.91)   168.84  (9.47) 
Body Mass Index (BMI) 
[Units: Kilograms Per Meter Squared]
Mean (Standard Deviation)
 28.67  (5.19)   28.25  (5.17)   28.71  (5.68)   28.54  (5.35) 


  Outcome Measures

1.  Primary:   Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score - Mixed-effects Model for Repeated Measures (MMRM) Analysis.   [ 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: NCT01377194     History of Changes
Other Study ID Numbers: LVM-MD-10
First Submitted: June 10, 2011
First Posted: June 21, 2011
Results First Submitted: August 22, 2013
Results First Posted: October 29, 2013
Last Update Posted: October 29, 2013