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The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER versus placebo in the treatment of outpatients with major depressive disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Placebo Comparator | Matching placebo capsules, oral administration, once daily dosing. |
|
| 1 | Experimental | Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levomilnacipran ER | Drug | Drug: Levomilnacipran ER (flexible dose) Study drug is to be given orally, in capsule form, once daily, for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | 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). | From Baseline to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sheehan Disability Scale (SDS) Total Score | 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) |
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Inclusion Criteria:
Exclusion Criteria:
Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing 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
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| Name | Affiliation | Role |
|---|---|---|
| Carl Gommoll, MS | Forest Research Institute, a subsidiary of Forest Laboratories, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site | Scottsdale | Arizona | 85254 | United States | ||
| Forest Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27536449 | Derived | Gommoll CP, Greenberg WM, Chen C. A randomized, double-blind, placebo-controlled study of flexible doses of levomilnacipran ER (40-120 mg/day) in patients with major depressive disorder. J Drug Assess. 2014 Jan 16;3(1):10-9. doi: 10.3109/21556660.2014.884505. eCollection 2014. | |
| 26644957 | Derived | Cutler AJ, Gommoll CP, Chen C, Greenberg WM, Ruth A. Levomilnacipran Extended-Release Treatment in Patients With Major Depressive Disorder: Improvements in Functional Impairment Categories. Prim Care Companion CNS Disord. 2015 Jun 11;17(3):10.4088/PCC.14m01753. doi: 10.4088/PCC.14m01753. eCollection 2015. |
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Patients went through a 1-week single-blind placebo run-in period immediately preceding an 8-week double-blind treatment period.
Patient were recruited over a 12-month period from September of 2009 to September of 2010 at 24 studies sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Dose Matched placebo capsules, oral administration, once daily dosing for 8 weeks. |
| FG001 | Levomilnacipran ER | Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Matching placebo to be given orally, in capsule form, once daily, for 8 weeks. |
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| From Baseline to Week 8 |
| Encino |
| California |
| 91316 |
| United States |
| Forest Investigative Site | Los Alamitos | California | 90720 | United States |
| Forest Investigative Site | Oceanside | California | 92056 | United States |
| Forest Investigative Site | Denver | Colorado | 80204 | United States |
| Forest Investigative Site | Denver | Colorado | 80239 | United States |
| Forest Investigative Site | Jacksonville | Florida | 32216 | United States |
| Forest Investigative Site | Orlando | Florida | 32806 | United States |
| Forest Investigative Site | Chicago | Illinois | 60634 | United States |
| Forest Investigative Site | Wichita | Kansas | 67206 | United States |
| Forest Investigative Site | Glen Burnie | Maryland | 21061 | United States |
| Forest Investigative Site | Fall River | Massachusetts | 02721 | United States |
| Forest Investigative Site | East Lansing | Michigan | 48824 | United States |
| Forest Investigative Site | Cherry Hill | New Jersey | 08002 | United States |
| Forest Investigative Site | Brooklyn | New York | 11235 | United States |
| Forest Investigative Site | New York | New York | 10021 | United States |
| Forest Investigative Site | Staten Island | New York | 10312 | United States |
| Forest Investigative Site 013 | Canton | Ohio | 44718 | United States |
| Forest Investigative Site | Dayton | Ohio | 45417 | United States |
| Forest Investigative Site | Portland | Oregon | 97210 | United States |
| Forest Investigative Site | Philadelphia | Pennsylvania | 19107 | United States |
| Forest Investigative Site | Lincoln | Rhode Island | 02865 | United States |
| Forest Investigative Site | Woodstock | Vermont | 05091 | United States |
| Forest Investigative Site | Bellevue | Washington | 98007 | United States |
| Forest Investigative Site | Seattle | Washington | 98104 | United States |
| COMPLETED |
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| NOT COMPLETED |
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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).
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching placebo capsules, oral administration, once daily dosing for 8 weeks. |
| BG001 | Levomilnacipran ER | Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | Kilograms Per Meter Squared |
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| 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 Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | 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). | Of the 357 patients who received at least 1 dose of double-blind treatment (Safety Population), 355 patients had at least 1 postbaseline MADRS assessment (Intent to Treat [ITT] Population). | Posted | Least Squares Mean | Standard Error | units on a scale | From Baseline to Week 8 |
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| Secondary | Change in Sheehan Disability Scale (SDS) Total Score | 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) | Posted | Least Squares Mean | Standard Error | units on a scale | From Baseline to Week 8 |
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Adverse event data was collection over a 14-month period from September 2009 to November 2010 at 24 study sites in the U.S.
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.
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| 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, once daily dosing for 8 weeks. | 1 | 182 | 58 | 182 | ||
| EG001 | Levomilnacipran ER | Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks. | 0 | 175 | 90 | 175 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood Pressure Increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Ejaculation disorder | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA 12.0 | Systematic Assessment |
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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 |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000078862 | Levomilnacipran |
| ID | Term |
|---|---|
| D000078764 | Milnacipran |
| D003521 | Cyclopropanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| 20 years to 29 years |
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| 30 years to 39 years |
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| 40 years to 49 years |
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| 50 years to 59 years |
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| 60 years to 80 years |
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| Male |
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| Black or African American |
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| Asian |
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| American Indian or Alaska native |
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| Other |
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| Hispanic or Latino |
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| Not Hispanic or Latino |
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