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The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER compared to placebo in patients with Major Depressive Disorder (MDD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 40mg Levomilnacipran ER |
|
| 2 | Experimental | 80mg of Levomilnacipran ER |
|
| 3 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levomilnacipran ER | Drug | Drug: Levomilnacipran ER 40mg/day 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 - Mixed-effects Model for Repeated Measures (MMRM) Analysis. | The Montgomery-Asberg Depression Rating Scale (MADRS) rates patients 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 was scored on a 7-point scale. A score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The minimum overall score possible was 0 (absence of symptoms), with a maximum overall score of 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:
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| Name | Affiliation | Role |
|---|---|---|
| Carl Gommoll, MS | Forest Research Institute, a subsidiary of Forest Laboratories | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site 039 | Birmingham | Alabama | 35216 | United States | ||
| Forest Investigative Site 037 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 24144196 | Derived |
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All patients went through a 1-week single-blind placebo run-in period before randomization.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Dose matched placebo, oral administration in capsule form, once daily for 8 weeks. |
| FG001 | Levomilnacipran ER 40 mg | 40mg of Levomilnacipran ER, oral administration in capsule form, once daily, for 8 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Levomilnacipran ER | Drug | Drug: Levomilnacipran ER 80mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks |
|
| Placebo | Drug | Matching placebo to be given orally, in capsule form, once daily, for 8 weeks. |
|
| From Baseline to Week 8 |
| Beverly Hills |
| California |
| 90210 |
| United States |
| Forest Investigative Site 012 | Encino | California | 91316 | United States |
| Forest Investigative Site 038 | Newport Beach | California | 92660 | United States |
| Forest Investigative Site 024 | Oceanside | California | 92056 | United States |
| Forest Investigative Site 001 | Redlands | California | 92374 | United States |
| Forest Investigative Site 031 | San Diego | California | 92108 | United States |
| Forest Investigative Site 050 | Sherman Oaks | California | 91403 | United States |
| Forest Investigative Site 034 | Cromwell | Connecticut | 06416 | United States |
| Forest Investigative Site 021 | Coral Springs | Florida | 33067 | United States |
| Forest Investigative Site 043 | Fort Myers | Florida | 33912 | United States |
| Forest Investigative Site 018 | Gainesville | Florida | 32607 | United States |
| Forest Investigative Site 060 | Hallandale | Florida | 33009 | United States |
| Forest Investigative Site 020 | Jacksonville | Florida | 32216 | United States |
| Forest Investigative Site 005 | Ocala | Florida | 34471 | United States |
| Forest Investigative Site 014 | Orlando | Florida | 32806 | United States |
| Forest Investigative Site 028 | Orlando | Florida | 32806 | United States |
| Forest Investigative Site 046 | Atlanta | Georgia | 30328 | United States |
| Forest Investigative Site 041 | Chicago | Illinois | 60634 | United States |
| Forest Investigative Site 054 | Chicago | Illinois | 60640 | United States |
| Forest Investigative Site 026 | Hoffman Estates | Illinois | 60169 | United States |
| Forest Investigative Site 045 | Indianapolis | Indiana | 46260 | United States |
| Forest Investigative Site 056 | Prairie Village | Kansas | 66206 | United States |
| Forest Investigative Site 049 | Haverhill | Massachusetts | 01830 | United States |
| Forest Investigative Site 044 | Cherry Hill | New Jersey | 08002 | United States |
| Forest Investigative Site 023 | Willingboro | New Jersey | 08046 | United States |
| Forest Investigative Site 004 | Brooklyn | New York | 11214 | United States |
| Forest Investigative Site 002 | Mount Kisco | New York | 10549 | United States |
| Forest Investigative Site 016 | New York | New York | 10003 | United States |
| Forest Investigative Site 051 | New York | New York | 10021 | United States |
| Forest Investigative Site 042 | Orangeburg | New York | 10962 | United States |
| Forest Investigative Site 061 | Raleigh | North Carolina | 27607 | United States |
| Forest Investigative Site 010 | Dayton | Ohio | 45417 | United States |
| Forest Investigative Site 048 | Oklahoma City | Oklahoma | 73112 | United States |
| Forest Investigative Site 053 | Portland | Oregon | 97210 | United States |
| Forest Investigative Site 017 | Salem | Oregon | 97301 | United States |
| Forest Investigative Site 011 | Allentown | Pennsylvania | 18104 | United States |
| Forest Investigative Site 052 | Bridgeville | Pennsylvania | 15017 | United States |
| Forest Investigative Site 027 | Philadelphia | Pennsylvania | 19107 | United States |
| Forest Investigative Site 059 | Lincoln | Rhode Island | 02865 | United States |
| Forest Investigative Site 029 | Memphis | Tennessee | 38119 | United States |
| Forest Investigative Site 009 | Dallas | Texas | 75231 | United States |
| Forest Investigative Site 007 | San Antonio | Texas | 78229 | United States |
| Forest Investigative Site 035 | San Antonio | Texas | 78229 | United States |
| Forest Investigative Site 022 | Bellevue | Washington | 98007 | United States |
| Forest Investigative Site 055 | Seattle | Washington | 98104 | United States |
| Forest Investigative Site 057 | Spokane | Washington | 99204 | United States |
| Forest Investigative Site 025 | Kelowna | British Columbia | V1Y 1Z9 | Canada |
| Forest Investigative Site 036 | Sydney | Nova Scotia | B1S 2EB | Canada |
| Forest Investigative Site 006 | Chatham | Ontario | N7M 1B7 | Canada |
| Forest Investigative Site 003 | Ottawa | Ontario | K1G 4G3 | Canada |
| Bakish D, Bose A, Gommoll C, Chen C, Nunez R, Greenberg WM, Liebowitz M, Khan A. Levomilnacipran ER 40 mg and 80 mg in patients with major depressive disorder: a phase III, randomized, double-blind, fixed-dose, placebo-controlled study. J Psychiatry Neurosci. 2014 Jan;39(1):40-9. doi: 10.1503/jpn.130040. |
| FG002 | Levomilnacipran ER 80 mg | 80mg of Levomilnacipran ER, oral administration in capsule form, once daily, for 8 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Baseline Participant population is based on the 562 randomized patients who went on to receive double-blind treatment (Safety Population).
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Dose matched placebo, oral administration in capsule form, once daily for 8 weeks. |
| BG001 | Levomilnacipran ER 40 mg | 40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks. |
| BG002 | Levomilnacipran 80 mg | 40mg Levomilnacipran ER, oral administration 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 |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| 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 Montgomery-Asberg Depression Rating Scale (MADRS) Total Score - Mixed-effects Model for Repeated Measures (MMRM) Analysis. | The Montgomery-Asberg Depression Rating Scale (MADRS) rates patients 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 was scored on a 7-point scale. A score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The minimum overall score possible was 0 (absence of symptoms), with a maximum overall score of 60 (maximum severity). | Of the 568 patients randomized to receive double-blind treatment, 562 patients received at least 1 dose of treatment and were included in the Safety Population, and 557 patients received at least 1 dose of treatment and had at least 1 postbaseline MADRS assessment and were included in the ITT Population. | Posted | Mean | Standard Deviation | 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) | Of the 568 patients randomized to receive double-blind treatment, 562 patients received at least 1 dose of treatment and were included in the Safety Population, and 557 patients received at least 1 dose of treatment and had at least 1 postbaseline MADRS assessment and were included in the ITT Population. | Posted | Least Squares Mean | Standard Error | units on a scale | From Baseline to Week 8 |
|
Adverse event data was collected over a 10 month period from June 2011 to March 2012.
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 | Dose matched placebo, oral administration in capsule form, once daily for 8 weeks. | 1 | 186 | 58 | 186 | ||
| EG001 | Levomilnacipran ER 40 mg | 40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks. | 3 | 188 | 90 | 188 | ||
| EG002 | Levomilnacipran 80 mg | 40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks. | 0 | 188 | 110 | 188 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Facial Bones Fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Urinary hesitation | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Testicular pain | Reproductive system and breast disorders | 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 PI will be patient to mutual agreement between the PI 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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| ≥ 20-29 |
|
| ≥ 30-39 |
|
| ≥ 40-49 |
|
| ≥ 50-59 |
|
| ≥ 60 |
|
| Male |
|
| Black or African-American |
|
| Asian |
|
| American Indian of Alaska Native |
|
| Native Hawaiian or other Pacific Islander |
|
| Other Race |
|
| Hispanic |
|
| Non-Hispanic |
|
| Canada |
|
| Least squares mean difference |
| -3.141 |
| 2-Sided |
| 95 |
| -5.293 |
| -0.988 |
| No |
| Superiority or Other |
|
|
|