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Trial record 20 of 1744 for:    depression AND Major Depression AND Scale | "Depression"

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

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ClinicalTrials.gov Identifier: NCT01034462
Recruitment Status : Completed
First Posted : December 17, 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, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: Levomilnacipran ER
Drug: Placebo
Enrollment 442

Recruitment Details Patient were recruited over a 21-month period from December of 2009 to September of 2011 at 23 studies sites in the United States.
Pre-assignment Details Patients went through a 1-week single-blind placebo run-in period immediately preceding an 8-week double-blind treatment period.
Arm/Group Title Placebo Levomilnacipran ER
Hide Arm/Group Description Matching placebo capsules, oral administration, once daily dosing for 8 weeks. Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
Period Title: Overall Study
Started 217 217
Completed 172 163
Not Completed 45 54
Reason Not Completed
Adverse Event             7             17
Lack of Efficacy             4             4
Protocol Violation             10             7
Withdrawal by Subject             9             8
Lost to Follow-up             14             16
Other reasons             1             2
Arm/Group Title Placebo Levomilnacipran ER Total
Hide Arm/Group Description Matching placebo capsules, oral administration, once daily dosing for 8 weeks. Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks. Total of all reporting groups
Overall Number of Baseline Participants 217 217 434
Hide Baseline Analysis Population Description
While 442 patients were randomized to receive double-blind treatment, 8 of these patients discontined before receiving double-blind treatment. The Baseline Participant population is based on the 434 randomized patients who went on to receive double-blind treatment (Safety Population).
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 217 participants 217 participants 434 participants
44.6  (13.9) 45.0  (13.2) 44.8  (13.5)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 217 participants 217 participants 434 participants
18 years to 19 years 2 2 4
20 years to 29 years 38 34 72
30 years to 39 years 37 44 81
40 years to 49 years 51 40 91
50 years to 59 years 57 68 125
60 years to 80 years 32 29 61
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 217 participants 217 participants 434 participants
Female
143
  65.9%
140
  64.5%
283
  65.2%
Male
74
  34.1%
77
  35.5%
151
  34.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 217 participants 217 participants 434 participants
White 182 177 359
Black or African American 28 33 61
Asian 2 2 4
American Indian or Alaska native 1 1 2
Other 4 4 8
Hispanic or Latino 17 21 38
Not Hispanic or Latino 200 196 396
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 217 participants 217 participants 434 participants
217 217 434
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 217 participants 217 participants 434 participants
84.58  (18.15) 84.47  (18.98) 84.52  (18.55)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilograms Per Meter Squared
Number Analyzed 217 participants 217 participants 434 participants
29.60  (5.30) 29.20  (5.45) 29.40  (5.37)
1.Primary Outcome
Title Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Hide Description

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).

Time Frame From Baseline to Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Safety Population consisted of 434 randomized patients who took at least 1 dose of double-blind investigational product. The Intent-to-Treat (ITT) Population consisted 429 patients in the Safety Population who had at least 1 postbaseline assessment of the MADRS total score.
Arm/Group Title Placebo Levomilnacipran ER
Hide Arm/Group Description:

Matching placebo capsules, oral administration, once daily dosing.

Placebo : Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.

Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks
Overall Number of Participants Analyzed 214 215
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-12.2  (0.78) -15.3  (0.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0051
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures.
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -3.095
Confidence Interval (2-Sided) 95%
-5.256 to -0.935
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Sheehan Disability Scale (SDS) Total Score
Hide Description The 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)
Time Frame From Baseline to Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

The Safety Population consisted of 434 randomized patients who took at least 1 dose of double-blind investigational product.

The Intent-to-Treat (ITT) Population consisted 429 patients in the Safety Population who had at least 1 postbaseline assessment of the MADRS total score.

Arm/Group Title Placebo Levomilnacipran ER
Hide Arm/Group Description:
Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
Overall Number of Participants Analyzed 214 215
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-5.4  (0.57) -8.0  (0.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levomilnacipran ER
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0010
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed-effects model for repeated measures.
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -2.632
Confidence Interval (2-Sided) 95%
-4.193 to -1.070
Estimation Comments [Not Specified]
Time Frame Adverse event data was collection over a 25-month period from December 2009 to January 2012 at 23 study sites in the U.S.
Adverse Event Reporting Description 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.
 
Arm/Group Title Placebo Levomilnacipran ER
Hide Arm/Group Description Matching placebo capsules, oral administration, once daily dosing for 8 weeks. Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
All-Cause Mortality
Placebo Levomilnacipran ER
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Levomilnacipran ER
Affected / at Risk (%) Affected / at Risk (%)
Total   3/217 (1.38%)   4/217 (1.84%) 
General disorders     
Non-cardiac chest pain  1  1/217 (0.46%)  1/217 (0.46%) 
Injury, poisoning and procedural complications     
Head injury  1  1/217 (0.46%)  0/217 (0.00%) 
Road traffic accident  1  1/217 (0.46%)  1/217 (0.46%) 
Traumatic liver injury  1  1/217 (0.46%)  0/217 (0.00%) 
Intentional overdose  1  0/217 (0.00%)  1/217 (0.46%) 
Road traffic accident  1  0/217 (0.00%)  1/217 (0.46%) 
Scratch  1  0/217 (0.00%)  1/217 (0.46%) 
Musculoskeletal and connective tissue disorders     
Back Pain  1  0/217 (0.00%)  1/217 (0.46%) 
Psychiatric disorders     
Suicide attempt  1  0/217 (0.00%)  1/217 (0.46%) 
Suicidal ideation  1  0/217 (0.00%)  2/217 (0.92%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/217 (0.46%)  0/217 (0.00%) 
Chronic obstructive pulmonary disease  1  1/217 (0.46%)  0/217 (0.00%) 
Vascular disorders     
Hypertension  1  0/217 (0.00%)  2/217 (0.92%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Levomilnacipran ER
Affected / at Risk (%) Affected / at Risk (%)
Total   79/217 (36.41%)   151/217 (69.59%) 
Cardiac disorders     
Tachycardia  1  6/217 (2.76%)  18/217 (8.29%) 
Gastrointestinal disorders     
Dry mouth  1  24/217 (11.06%)  27/217 (12.44%) 
Constipation  1  8/217 (3.69%)  22/217 (10.14%) 
Diarrhoea  1  12/217 (5.53%)  14/217 (6.45%) 
Vomiting  1  2/217 (0.92%)  14/217 (6.45%) 
Infections and infestations     
Upper respiratory tract infection  1  9/217 (4.15%)  13/217 (5.99%) 
Nervous system disorders     
Nausea  1  8/217 (3.69%)  47/217 (21.66%) 
Headache  1  27/217 (12.44%)  38/217 (17.51%) 
Dizziness  1  7/217 (3.23%)  28/217 (12.90%) 
Psychiatric disorders     
Insomnia  1  5/217 (2.30%)  15/217 (6.91%) 
Renal and urinary disorders     
Urinary hesitation  1  0/217 (0.00%)  17/217 (7.83%) 
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  4/217 (1.84%)  15/217 (6.91%) 
Vascular disorders     
Hypertension  1  3/217 (1.38%)  12/217 (5.53%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
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.

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.

Results Point of Contact
Name/Title: Carl Gommoll, MS, Sr. Dir. Clinical Development Psychiatry
Organization: Forest Research Institute
Phone: 201-427-8000 ext 8124