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Trial record 45 of 134 for:    "Depressive Disorder" [DISEASE] | ( Map: Arkansas, United States )

Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Adults With Fatigue Associated With 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: NCT01254305
Recruitment Status : Completed
First Posted : December 6, 2010
Results First Posted : August 6, 2014
Last Update Posted : August 6, 2014
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: Paroxetine, Sertraline, Citalopram or Fluoxetine.
Drug: Placebo
Enrollment 262
Recruitment Details Patients were recruited over a 12-month period from April of 2011 to April of 2012 at 20 studies sites in the United States.
Pre-assignment Details Patients went through a 1-week single-blind placebo run-in period, followed by an 8-week double-blind treatment period.
Arm/Group Title Placebo Levomilnacipran ER SSRI
Hide Arm/Group Description Matching placebo capsules, oral administration, once daily dosing. 40 -120 mg Levomilnacipran ER capsules, oral administration once daily for 8 weeks.

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.

Period Title: Overall Study
Started 93 90 79
Safety Population 89 85 77
Completed 71 72 62
Not Completed 22 18 17
Reason Not Completed
Adverse Event             6             3             2
Lack of Efficacy             1             0             1
Protocol Violation             1             7             3
Withdrawal by Subject             4             2             4
Lost to Follow-up             10             6             5
Other Reasons             0             0             2
Arm/Group Title Placebo Levomilnacipran ER SSRI Total
Hide Arm/Group Description

Matching placebo capsules, oral administration

Placebo : Matching placebo capsules, oral administration, once daily dosing

40 - 120 mg Levomilnacipran ER capsules, oral administration, once daily for 8 weeks

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 of all reporting groups
Overall Number of Baseline Participants 89 85 77 251
Hide Baseline Analysis Population Description
A total of 262 patients were randomized to receive double-blind treatment. The Baseline Participant population is based on the 251 randomized patients received at least 1 dose of double-blind treatment (Safety Population).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 89 participants 85 participants 77 participants 251 participants
41.4  (12.0) 42.9  (12.6) 42.8  (11.3) 42.3  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 85 participants 77 participants 251 participants
Female
58
  65.2%
49
  57.6%
49
  63.6%
156
  62.2%
Male
31
  34.8%
36
  42.4%
28
  36.4%
95
  37.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 89 participants 85 participants 77 participants 251 participants
White 62 57 47 166
Black or African American 26 25 25 76
Asian 1 3 2 6
American Indian or Alaska Native 0 0 1 1
Native Hawaiian or Other Pacific Islander 0 0 0 0
Other 0 0 2 2
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 89 participants 85 participants 77 participants 251 participants
Hispanic or Latino 8 4 10 22
Not Hispanic or Latino 81 81 67 229
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 89 participants 85 participants 77 participants 251 participants
89 85 77 251
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 89 participants 85 participants 77 participants 251 participants
79.95  (15.27) 82.23  (18.14) 83.31  (17.61) 81.75  (17.00)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilograms Per Meter Squared
Number Analyzed 89 participants 85 participants 77 participants 251 participants
28.16  (4.85) 28.61  (5.22) 28.80  (5.10) 28.51  (5.04)
1.Primary Outcome
Title Change in Clinical Global Impression of Severity (CGI-S) for Fatigue Score
Hide Description 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
Time Frame From Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Placebo Levomilnacipran ER SSRI
Hide Arm/Group Description:
Dose matched placebo, oral administration in capsule form, once daily for 8 weeks
40 - 120 mg Levomilnacipran ER capsules, oral administration in capsule form, once daily for 8 weeks

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 Number of Participants Analyzed 88 85 75
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.5  (1.3) -1.8  (1.4) -1.9  (1.4)
2.Primary Outcome
Title Change in Patient Global Impressions of Severity (PGI-S) for Fatigue Score
Hide Description 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.
Time Frame From Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Placebo Levomilnacipran ER SSRI
Hide Arm/Group Description:
Dose matched placebo, oral administration in capsule form, once daily for 8 weeks
40 - 120 mg Levomilnacipran ER capsules, oral administration once per day for 8 weeks.

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 Number of Participants Analyzed 88 85 75
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.4  (1.5) -1.7  (1.5) -1.7  (1.5)
3.Secondary Outcome
Title Change in Cognitive and Physical Functioning Questionnaire (CPFQ), Last Observation Carried Forward
Hide Description 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).
Time Frame From Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Levomilnacipran ER SSRI
Hide Arm/Group Description:
Dose matched placebo capsules, oral administration for 8 weeks.
40 - 120 mg Levomilnacipran ER capsules, oral administration once per day for 8 weeks

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 Number of Participants Analyzed 88 85 75
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.9  (7.9) -7.0  (7.3) -6.4  (7.0)
Time Frame 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.
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 SSRI
Hide Arm/Group Description

Matching placebo capsules, oral administration

Placebo : Matching placebo capsules, oral administration, once daily dosing

40 -120 mg Levomilnacipran ER capsules, oral administration, once daily for 8 weeks

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.

All-Cause Mortality
Placebo Levomilnacipran ER SSRI
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Levomilnacipran ER SSRI
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/89 (0.00%)   1/85 (1.18%)   0/77 (0.00%) 
Infections and infestations       
Pneumonia  1  0/89 (0.00%)  1/85 (1.18%)  0/77 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
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 SSRI
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   39/89 (43.82%)   41/85 (48.24%)   37/77 (48.05%) 
Gastrointestinal disorders       
Dry mouth  1  6/89 (6.74%)  8/85 (9.41%)  9/77 (11.69%) 
Diarrhoea  1  8/89 (8.99%)  4/85 (4.71%)  9/77 (11.69%) 
General disorders       
Nausea  1  4/89 (4.49%)  14/85 (16.47%)  6/77 (7.79%) 
Infections and infestations       
Upper respiratory tract infection  1  7/89 (7.87%)  0/85 (0.00%)  3/77 (3.90%) 
Investigations       
Heart rate increased  1  3/89 (3.37%)  6/85 (7.06%)  0/77 (0.00%) 
Nervous system disorders       
Headache  1  14/89 (15.73%)  12/85 (14.12%)  6/77 (7.79%) 
Dizziness  1  2/89 (2.25%)  6/85 (7.06%)  1/77 (1.30%) 
Somnolence  1  4/89 (4.49%)  3/85 (3.53%)  6/77 (7.79%) 
Psychiatric disorders       
Insomnia  1  1/89 (1.12%)  2/85 (2.35%)  5/77 (6.49%) 
Anxiety  1  1/89 (1.12%)  1/85 (1.18%)  5/77 (6.49%) 
Initial insomnia  1  1/89 (1.12%)  1/85 (1.18%)  5/77 (6.49%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
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
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01254305     History of Changes
Other Study ID Numbers: LVM-MD-06
First Submitted: December 3, 2010
First Posted: December 6, 2010
Results First Submitted: August 22, 2013
Results First Posted: August 6, 2014
Last Update Posted: August 6, 2014