Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to evaluate the efficacy, safety and tolerability of Levomilnacipran ER for the treatment of fatigue associated with major depressive disorder (MDD).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 40 -120 mg/day Levomilnacipran ER capsules, oral administration |
|
| 2 | Active Comparator | Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine Oral administration, once daily dosing |
|
| 3 | Placebo Comparator | Matching placebo capsules, oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levomilnacipran ER | Drug | Drug: Levomilnacipran ER (40 -120 mg/day) Study drug is to be given orally, in capsule form, once daily for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Global Impression of Severity (CGI-S) for Fatigue Score | 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 | From Baseline to Week 8 |
| Change in Patient Global Impressions of Severity (PGI-S) for Fatigue Score | 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. | From Baseline to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cognitive and Physical Functioning Questionnaire (CPFQ), Last Observation Carried Forward | 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Women who are pregnant, women who will be breastfeeding during the study, and women of child-bearing potential who are not practicing a reliable method of birth control
Patients with a history of meeting DSM-IV-TR criteria for:
Patients who are considered a suicide risk
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Carl Gommoll, MS | Forest Laboratories | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site 010 | Birmingham | Alabama | 35216 | United States | ||
| Forest Investigative Site 002 |
Patients went through a 1-week single-blind placebo run-in period, followed by an 8-week double-blind treatment period.
Patients were recruited over a 12-month period from April of 2011 to April of 2012 at 20 studies sites in the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching placebo capsules, oral administration, once daily dosing. |
| FG001 | Levomilnacipran ER | 40 -120 mg Levomilnacipran ER capsules, oral administration once daily for 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Paroxetine, Sertraline, Citalopram or Fluoxetine. | Drug | 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 |
|
| Placebo | Drug | Matching placebo capsules, oral administration, once daily dosing |
|
| From Baseline to Week 8 |
| Little Rock |
| Arkansas |
| 72223 |
| United States |
| Forest Investigative Site 001 | Cerritos | California | 90703 | United States |
| Forest Investigative Site 014 | Fort Myers | Florida | 33912 | United States |
| Forest Investigative Site 006 | Jacksonville | Florida | 32216 | United States |
| Forest Investigative Site 017 | Orange City | Florida | 32763 | United States |
| Forest Investigative Site 005 | Orlando | Florida | 32806 | United States |
| Forest Investigative Site 012 | Tampa | Florida | 33613 | United States |
| Forest Investigative Site 009 | Atlanta | Georgia | 30308 | United States |
| Forest Investigative Site 016 | Joliet | Illinois | 60435 | United States |
| Forest Investigative Site 004 | New Orleans | Louisiana | 70122 | United States |
| Forest Investigative Site 022 | Boston | Massachusetts | 02135 | United States |
| Forest Investigative Site 015 | Cedarhurst | New York | 11516 | United States |
| Forest Investigative Site 011 | The Bronx | New York | 10467 | United States |
| Forest Investigative Site 003 | Cincinnati | Ohio | 45227 | United States |
| Forest Investigative Site 013 | Dayton | Ohio | 45417 | United States |
| Forest Investigative Site 020 | Lincoln | Rhode Island | 02865 | United States |
| Forest Investigative Site 018 | Memphis | Tennessee | 38119 | United States |
| Forest Investigative Site 008 | Dallas | Texas | 75235 | United States |
| Forest Investigative Site 007 | Middleton | Wisconsin | 53562 | United States |
| FG002 | SSRI | 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. |
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching placebo capsules, oral administration Placebo : Matching placebo capsules, oral administration, once daily dosing |
| BG001 | Levomilnacipran ER | 40 - 120 mg Levomilnacipran ER capsules, oral administration, once daily for 8 weeks |
| BG002 | SSRI | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | Kilograms Per Meter Squared |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Clinical Global Impression of Severity (CGI-S) for Fatigue Score | 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 | 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. | Posted | Mean | Standard Deviation | units on a scale | From Baseline to Week 8 |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Change in Cognitive and Physical Functioning Questionnaire (CPFQ), Last Observation Carried Forward | 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | From Baseline to Week 8 |
| |||||||||||||||||||||||||||||||||
| Primary | Change in Patient Global Impressions of Severity (PGI-S) for Fatigue Score | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | From Baseline to Week 8 |
|
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.
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Matching placebo capsules, oral administration Placebo : Matching placebo capsules, oral administration, once daily dosing | 0 | 89 | 39 | 89 | ||
| EG001 | Levomilnacipran ER | 40 -120 mg Levomilnacipran ER capsules, oral administration, once daily for 8 weeks | 1 | 85 | 41 | 85 | ||
| EG002 | SSRI | 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. | 0 | 77 | 37 | 77 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Initial insomnia | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carl Gommoll, MS, Sr. Dir. Clinical Development Psychiatry | Forest Research Institute | 201-427-8000 | 8124 | carl.gommoll@frx.com |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078862 | Levomilnacipran |
| D017374 | Paroxetine |
| D020280 | Sertraline |
| D015283 | Citalopram |
| D005473 | Fluoxetine |
| ID | Term |
|---|---|
| D000078764 | Milnacipran |
| D003521 | Cyclopropanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D011437 | Propylamines |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Male |
|
| Black or African American |
|
| Asian |
|
| American Indian or Alaska Native |
|
| Native Hawaiian or Other Pacific Islander |
|
| Other |
|
| Not Hispanic or Latino |
|
| SSRI |
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. |
|
|
|
|