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 this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER versus placebo in the treatment of outpatients with major depressive disorder
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing. |
|
| 2 | Placebo Comparator | Matching placebo capsules, oral administration, once daily dosing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levomilnacipran ER | Drug | Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing. 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 055 | Dothan | Alabama | 36305 | United States | ||
| Forest Investigative Site 065 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27861191 | Derived | Wesnes KA, Gommoll C, Chen C, Sambunaris A, McIntyre RS, Harvey PD. Effects of levomilnacipran extended-release on major depressive disorder patients with cognitive impairments: post-hoc analysis of a phase III study. Int Clin Psychopharmacol. 2017 Mar;32(2):72-79. doi: 10.1097/YIC.0000000000000157. | |
| 26644957 | Derived |
Not provided
Not provided
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 21-month period from December of 2009 to September of 2011 at 23 studies sites in the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching 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 |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Matching placebo to be given orally, in capsule form, once daily, for 8 weeks. |
|
| From Baseline to Week 8 |
| Highlands Ranch |
| Colorado |
| 80130 |
| United States |
| Forest Investigative Site 057 | Boca Raton | Florida | 33431 | United States |
| Forest Investigative Site 060 | Boca Raton | Florida | 33432 | United States |
| Forest Investigative Site 064 | Gainesville | Florida | 32607 | United States |
| Forest Investigative Site 053 | Ocala | Florida | 34471 | United States |
| Forest Investigative Site 061 | Orlando | Florida | 32806 | United States |
| Forest Investigative Site 059 | Winter Park | Florida | 32789 | United States |
| Forest Investigative Site 070 | Atlanta | Georgia | 30328 | United States |
| Forest Investigative Site 066 | Smyrna | Georgia | 30080 | United States |
| Forest Investigative Site 072 | Chicago | Illinois | 60634 | United States |
| Forest Investigative Site 050 | Oak Brook | Illinois | 60523 | United States |
| Forest Investigative Site 063 | Indianapolis | Indiana | 46260 | United States |
| Forest Investigative Site 071 | Prairie Village | Kansas | 66206 | United States |
| Forest Investigative Site 052 | Shreveport | Louisiana | 71104 | United States |
| Forest Investigative Site 051 | Brooklyn | New York | 11214 | United States |
| Forest Investigative Site 056 | Oklahoma City | Oklahoma | 73112 | United States |
| Forest Investigative Site 067 | Oklahoma City | Oklahoma | 73112 | United States |
| Forest Investigative Site 058 | Salem | Oregon | 97301 | United States |
| Forest Investigative Site 054 | Allentown | Pennsylvania | 18104 | United States |
| Forest Investigative Site 062 | San Antonio | Texas | 78229 | United States |
| Forest Investigative Site 068 | Virginia Beach | Virginia | 23452 | United States |
| Forest Investigative Site 069 | Spokane | Washington | 99204 | United States |
| 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. |
| 24172209 | Derived | Sambunaris A, Bose A, Gommoll CP, Chen C, Greenberg WM, Sheehan DV. A phase III, double-blind, placebo-controlled, flexible-dose study of levomilnacipran extended-release in patients with major depressive disorder. J Clin Psychopharmacol. 2014 Feb;34(1):47-56. doi: 10.1097/JCP.0000000000000060. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
While 442 patients were randomized to receive double-blind treatment, 8 of these patients discontined before receiving double-blind treatment. The Baseline Participant population is based on the 434 randomized patients who went on to receive double-blind treatment (Safety Population).
Not provided
| 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 |
|
| 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-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). | The Safety Population consisted of 434 randomized patients who took at least 1 dose of double-blind investigational product. The Intent-to-Treat (ITT) Population consisted 429 patients in the Safety Population who had at least 1 postbaseline assessment of the MADRS total score. | 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 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) | The Safety Population consisted of 434 randomized patients who took at least 1 dose of double-blind investigational product. The Intent-to-Treat (ITT) Population consisted 429 patients in the Safety Population who had at least 1 postbaseline assessment of the MADRS total score. | Posted | Least Squares Mean | Standard Error | units on a scale | From Baseline to Week 8 |
|
|
Adverse event data was collection over a 25-month period from December 2009 to January 2012 at 23 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.
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, once daily dosing for 8 weeks. | 3 | 217 | 79 | 217 | ||
| EG001 | Levomilnacipran ER | Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks. | 4 | 217 | 151 | 217 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-cardiac chest pain | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Traumatic liver injury | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Scratch | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Urinary hesitation | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Hypertension | Vascular 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078862 | Levomilnacipran |
| ID | Term |
|---|---|
| D000078764 | Milnacipran |
| D003521 | Cyclopropanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
| 20 years to 29 years |
|
| 30 years to 39 years |
|
| 40 years to 49 years |
|
| 50 years to 59 years |
|
| 60 years to 80 years |
|
| Male |
|
| Black or African American |
|
| Asian |
|
| American Indian or Alaska native |
|
| Other |
|
| Hispanic or Latino |
|
| Not Hispanic or Latino |
|
|
|