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The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER fixed doses versus placebo in the treatment of outpatients with major depressive disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 40 mg Levomilnacipran ER capsules, low dose, oral administration, once daily. |
|
| 2 | Experimental | 80 mg Levomilnacipran ER capsules, medium dose, oral administration, once daily dosing |
|
| 3 | Experimental | 120 mg Levomilnacipran ER capsules, high dose, oral administration, once daily dosing |
|
| 4 | Placebo Comparator | Matching placebo capsules, oral administration, once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levomilnacipran ER | Drug | Levomilnacipran ER, 40 mg, oral administration, in capsule form, once daily for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | The 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 for all measured symptoms). | 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 functional 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 for all measured symptoms) |
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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 | Phoenix | Arizona | 85020 | United States | ||
| Forest Investigative Site |
| 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. | |
| 25259674 | Derived |
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The study included a 1-week, single-blind placebo run-in period immediately before the 8-week double-blind treatment period.
Patient recruitment at 38 study centers located in the United States during a 17 month period from September 2009 to February 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Dose matching placebo capsules, oral administration, once daily dosing. Placebo : Matching placebo capsules, oral administration, once daily for 8 weeks. |
| FG001 | Levomilnacipran ER 40 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Levomilnacipran ER | Drug | Levomilnacipran ER, 80 mg, oral administration, in capsule form, once daily for 8 weeks. |
|
| Levomilnacipran ER | Drug | Levomilnacipran ER, 120 mg, oral administration, in capsule form, once daily for 8 weeks. |
|
| Placebo | Drug | Matching placebo capsules, oral administration, once daily for 8 weeks. |
|
| From Baseline to Week 8 |
| Scottsdale |
| Arizona |
| 85254 |
| United States |
| Forest Investigative Site | Beverly Hills | California | 90210 | United States |
| Forest Investigative Site | Costa Mesa | California | 92626 | United States |
| Forest Investigative Site | Escondido | California | 92025 | United States |
| Forest Investigative Site | Oceanside | California | 92056 | United States |
| Forest Investigative Site | Sherman Oaks | California | 91403 | United States |
| Forest Investigative Site | Denver | Colorado | 80239 | United States |
| Forest Investigative Site | Cromwell | Connecticut | 06416 | United States |
| Forest Investigative Site | Coral Springs | Florida | 33067 | United States |
| Forest Investigative Site | Fort Myers | Florida | 33912 | United States |
| Forest Investigative Site | Hallandale | Florida | 33009 | United States |
| Forest Investigative Site | Jacksonville | Florida | 32216 | United States |
| Forest Investigative Site | Orlando | Florida | 32806 | United States |
| Forest Investigative Site | West Palm Beach | Florida | 33407 | United States |
| Forest Investigative Site | Hoffman Estates | Illinois | 60169 | United States |
| Forest Investigative Site | Wichita | Kansas | 67206 | United States |
| Forest Investigative Site | Baltimore | Maryland | 21285 | United States |
| Forest Investigative Site | Rockville | Maryland | 20852 | United States |
| Forest Investigative Site | Cherry Hill | New Jersey | 08002 | United States |
| Forest Investigative Site | Willingboro | New Jersey | 08046 | United States |
| Forest Investigative Site | Brooklyn | New York | 11235 | United States |
| Forest Investigative Site | Mount Kisco | New York | 10549 | United States |
| Forest Investigative Site | New York | New York | 10003 | 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 | Raleigh | North Carolina | 27607 | United States |
| Forest Investigative Site | Canton | Ohio | 44718 | United States |
| Forest Investigative Site | Portland | Oregon | 97210 | United States |
| Forest Investigative Site | Media | Pennsylvania | 19063 | United States |
| Forest Investigative Site | Norristown | Pennsylvania | 19403 | United States |
| Forest Investigative Site | Lincoln | Rhode Island | 02865 | United States |
| Forest Investigative Site | Memphis | Tennessee | 38119 | United States |
| Forest Investigative Site | Dallas | Texas | 75230 | United States |
| Forest Investigative Site | Dallas | Texas | 75231 | United States |
| Forest Investigative Site | San Antonio | Texas | 78229 | United States |
| Forest Investigative Site | Bellevue | Washington | 98007 | United States |
| Forest Investigative Site | Seattle | Washington | 98104 | United States |
| Blum SI, Tourkodimitris S, Ruth A. Evaluation of functional health and well-being in patients receiving levomilnacipran ER for the treatment of major depressive disorder. J Affect Disord. 2015 Jan 1;170:230-6. doi: 10.1016/j.jad.2014.09.005. Epub 2014 Sep 10. |
| 23561229 | Derived | Asnis GM, Bose A, Gommoll CP, Chen C, Greenberg WM. Efficacy and safety of levomilnacipran sustained release 40 mg, 80 mg, or 120 mg in major depressive disorder: a phase 3, randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2013 Mar;74(3):242-8. doi: 10.4088/JCP.12m08197. |
40 mg/day Levomilnacipran ER capsules, low dose, oral administration, once daily dosing.
Levomilnacipran ER, low dose, oral administration, in capsule form, once daily for 8 weeks.
| FG002 | Levomilnacipran ER 80 mg | 80 mg/day Levomilnacipran ER capsules, medium dose, oral administration, once daily dosing Levomilnacipran ER, medium dose, oral administration, in capsule form, once daily for 8 weeks. |
| FG003 | Levomilnacipran ER 120 mg | 120 mg/day Levomilnacipran ER capsules, high dose, oral administration, once daily dosing Levomilnacipran ER, high dose, oral administration, in capsule form, once daily for 8 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
A total of 724 patients were randomized to receive double-blind treatment (Randomized Population); 713 patients received at least 1 dose of treatment (Safety Population). The demographic analyses of the baseline participants is based on the Safety Population
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Dose matching placebo capsules, oral administration, once daily dosing for 8 weeks |
| BG001 | Levomilnacipran ER 40 mg | 40 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks. |
| BG002 | Levomilnacipran ER 80 mg | 80 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks. |
| BG003 | Levomilnacipran ER 120 mg | 120 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks. |
| BG004 | 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 |
| |||||||||||||||
| 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-Åsberg Depression Rating Scale (MADRS) Total Score | The 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 for all measured symptoms). | A total of 724 patients were randomized to receive double-blind treatment (Randomized Population); 713 patients received at least 1 dose of treatment (Safety Population); and 704 patients received at least 1 dose of treatment and had at least 1 postbaseline MADRS-CR assessment (Intent to Treat [ITT] Population). | Posted | Least Squares Mean | Standard Error | Units on a scale | From Baseline to Week 8 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Sheehan Disability Scale (SDS) Total Score | The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate functional 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 for all measured symptoms) | A total of 724 patients were randomized to receive double-blind treatment (Randomized Population); 713 patients received at least 1 dose of treatment (Safety Population); and 704 patients received at least 1 dose of treatment and had at least 1 postbaseline MADRS-CR assessment(Intent to Treat [ITT] Population). | Posted | Mean | Standard Error | units on a scale | From Baseline to Week 8 |
|
Adverse event data was collected over a 20 month period from September 2009 to June 2011 at 38 study sites.
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 matching placebo capsules, oral administration, once daily dosing for 8 weeks. | 1 | 176 | 66 | 176 | ||
| EG001 | Levomilnacipran ER 40 mg | 40 mg per day Levomilnacipran ER, low dose, oral administration, once daily for 8 weeks. | 3 | 178 | 110 | 178 | ||
| EG002 | Levomilnacipran ER 80 mg | 80 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks. | 2 | 179 | 122 | 179 | ||
| EG003 | Levomilnacipran ER 120 mg | 120 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks. | 1 | 180 | 112 | 180 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aggression | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cytomegalovirus mononucleosis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Suicide Attempt | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Premature baby | Pregnancy, puerperium and perinatal conditions | MedDRA 11.1 | Systematic Assessment |
| |
| Small for dates baby | Pregnancy, puerperium and perinatal conditions | MedDRA 11.1 | Systematic Assessment |
| |
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA 11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Urinary hesitation | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Ejaculation delayed | Reproductive system and breast disorders | MedDRA 11.1 | 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 |
| 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 |
|
| 30 years to 39 years |
|
| 40 years to 49 years |
|
| 50 years to 59 years |
|
| 60 years to 65 years |
|
| Male |
|
| Black or African American |
|
| Asian |
|
| American Indian or Alaska native |
|
| Native Hawaiian or other Pacific Islander |
|
| Other |
|
| Hispanic or Latino |
|
| Not Hispanic or Latino |
|
Mixed-effects model for repeated measures. |
| 0.0038 |
| Least squares mean difference |
| -3.99 |
| 2-Sided |
| 95 |
| -6.69 |
| -1.29 |
| No |
| Superiority or Other |
| Mixed Models Analysis | Mixed-effects model for repeated measures. | 0.0005 | Least squares mean difference | -4.86 | 2-Sided | 95 | -7.59 | -2.12 | No | Superiority or Other |
| OG003 | Levomilnacipran ER 120 mg | 120 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks. |
|
|
|