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The purpose of this study is to evaluate the safety and efficacy of Levomilnacipran ER relative to placebo in the prevention of depression relapse in patients with major depressive disorder (MDD).
Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with Levomilnacipran ER are randomized to continue Levomilnacipran ER or switch to placebo under double-blind conditions for up to 24 weeks of additional treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Experimental | 40, 80 or 120 mg/day Levomilnacipran ER capsules, oral administration, once daily dosing. |
|
| 1 | Placebo Comparator | Matching placebo capsules, oral administration, once daily dosing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levomilnacipran ER | Drug | Drug: Levomilnacipran ER (40, 80 or 120 mg/day) Study drug is to be given orally, in capsule form, once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Relapse (Days) | Number of days until patients meet relapse criteria. Relapse was defined as 1 or more of the following: 1. MADRS total score of at least 22 at 2 consecutive visits 2. Increase of 2 or more points in CGI-I score compared with the CGI-I score at Visit 9 at 2 consecutive visits 3. Premature discontinuation due to insufficient therapeutic response 4. MADRS item 10 score of at least 4 | 24 Weeks |
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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 |
|---|---|---|
| Giovanna Forero, MA | Forest Laboratories | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site #023 | Beverly Hills | California | 90210 | United States | ||
| Forest Investigative Site #017 |
Patients began with a 12-week open-label treatment period, followed by a 24-week double-blind treatment period.
Patient were recruited over a 10-month period from March of 2010 to January of 2011 at 36 studies sites, 30 in the United States and 6 in Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching placebo capsules, oral administration, once daily dosing. |
| FG001 | Levomilnacipran ER | 40, 80 or 120 mg/day Levomilnacipran ER capsules, oral administration, once daily dosing. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Open-Label Period |
|
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| Placebo | Drug | Matching placebo to be given orally, in capsule form, once daily. |
|
| Encino |
| California |
| 31316 |
| United States |
| Forest Investigative Site #021 | Garden Grove | California | 92845 | United States |
| Forest Investigative Site #025 | Newport Beach | California | 92660 | United States |
| Forest Investigative Site #030 | Orange | California | 92868 | United States |
| Forest Investigative Site #002 | San Diego | California | 92108 | United States |
| Forest Investigative Site #003 | Sherman Oaks | California | 91403 | United States |
| Forest Research Institute #001 | Bonita Springs | Florida | 34134 | United States |
| Forest Investigative Site #015 | Fort Myers | Florida | 33912 | United States |
| Forest Investigative Site #029 | Maitland | Florida | 32751 | United States |
| Forest Investigative Site #005 | North Miami | Florida | 33161 | United States |
| Forest Investigative Site #016 | Orlando | Florida | 32806 | United States |
| Forest Investigative Site #004 | South Miami | Florida | 33143 | United States |
| Forest Investigative Site #014 | Atlanta | Georgia | 30328 | United States |
| Forest Investigative Site #022 | Chicago | Illinois | 60634 | United States |
| Forest Investigative Site #006 | Chicago | Illinois | 60640 | United States |
| Forest Investigative Site #009 | Prairie Village | Kansas | 66206 | United States |
| Forest Investigative Site #013 | Baltimore | Maryland | 21208 | United States |
| Forest Investigative Site #010 | Boston | Massachusetts | 02135 | United States |
| Forest Investigative Site #012 | St Louis | Missouri | 63139 | United States |
| Forest Investigative Site #011 | Staten Island | New York | 10312 | United States |
| Forest Investigative Site #026 | Portland | Oregon | 97210 | United States |
| Forest Investigative Site #008 | Bridgeville | Pennsylvania | 15017 | United States |
| Forest Investigative Site #028 | Norristown | Pennsylvania | 19401 | United States |
| Forest Investigative Site #020 | Philadelphia | Pennsylvania | 19139 | United States |
| Forest Investigative Site #024 | Memphis | Tennessee | 38119 | United States |
| Forest Investigative Site #007 | Dallas | Texas | 75231 | United States |
| Forest Investigative Site #019 | San Antonio | Texas | 78229 | United States |
| Forest Investigative Site #018 | Bellevue | Washington | 98007 | United States |
| Forest Investigative Site #027 | Seattle | Washington | 98104 | United States |
| Forest Investigative Site #050 | Kelowna | British Columbia | V1Y 1Z9 | Canada |
| Forest Investigative Site #051 | Vancouver | British Columbia | V6Z 2L4 | Canada |
| Forest Investigative Site #052 | Sydney | Nova Scotia | B1S 2E8 | Canada |
| Forest Investigative Site #055 | Chatham | Ontario | N7M 1B7 | Canada |
| Forest Investigative Site #053 | Ottawa | Ontario | K1G 4G3 | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Double-Blind Period |
|
|
| Double-blind Intent-to-treat Population |
|
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The Baseline Participant population is based on the 734 enrolled patients who received at least one dose of open-label treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Label Levomilnacipran ER | 40, 80 or 120 mg Levomilnacipran ER capsules, oral administration, once daily dosing. |
| 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 | Count of Participants | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Count of Participants | 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 | Time to Relapse (Days) | Number of days until patients meet relapse criteria. Relapse was defined as 1 or more of the following: 1. MADRS total score of at least 22 at 2 consecutive visits 2. Increase of 2 or more points in CGI-I score compared with the CGI-I score at Visit 9 at 2 consecutive visits 3. Premature discontinuation due to insufficient therapeutic response 4. MADRS item 10 score of at least 4 | The double blind Intent-to-treat population consists of 342 randomized participants who received study drug and were evaluated for the Primary Outcome Measure | Posted | Mean | Standard Deviation | Days | 24 Weeks |
|
|
|
Adverse event data was collection over a 20-month period from March 2010 to November 2011 at 36 study sites in the U.S and Canada.
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 24 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 | Open Label Levomilnacipran ER | 40, 80 or 120 mg Levomilnacipran ER capsules, oral administration, once daily dosing. | 0 | 734 | 7 | 734 | 448 | 734 |
| EG001 | Placebo - Double Blind Treatment | Matching placebo capsules, oral administration, once daily dosing. | 0 | 112 | 4 | 112 | 31 | 112 |
| EG002 | Levomilnacipran ER - Double Blind Treatment | 40, 80 or 120 mg Levomilnacipran ER capsules, oral administration, once daily dosing. | 0 | 233 | 2 | 233 | 68 | 233 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase MB increased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Drug abuse | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Intentional self-injury | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Suicidal behaviour | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Troponin I increased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | 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 |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA 14.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
This was a failed study. The lower than expected rate of relapse in the placebo group compromised the projected power to demonstrate a difference between groups.
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 |
|---|---|
| D003863 | Depression |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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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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| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Other Reasons |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Positive serum pregnancy test result |
|
| 30 years to 39 years |
|
| 40 years to 49 years |
|
| 50 years to 59 years |
|
| 60 years to 65 years |
|