- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00969709
Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder
A Double-blind, Placebo-Controlled, Fixed-Dose Study of F2695 SR in Patients With Major Depressive Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85020
- Forest Investigative Site
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Scottsdale, Arizona, United States, 85254
- Forest Investigative Site
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California
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Beverly Hills, California, United States, 90210
- Forest Investigative Site
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Costa Mesa, California, United States, 92626
- Forest Investigative Site
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Escondido, California, United States, 92025
- Forest Investigative Site
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Oceanside, California, United States, 92056
- Forest Investigative Site
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Sherman Oaks, California, United States, 91403
- Forest Investigative Site
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Colorado
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Denver, Colorado, United States, 80239
- Forest Investigative Site
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Connecticut
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Cromwell, Connecticut, United States, 06416
- Forest Investigative Site
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Florida
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Coral Springs, Florida, United States, 33067
- Forest Investigative Site
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Fort Myers, Florida, United States, 33912
- Forest Investigative Site
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Hallandale Beach, Florida, United States, 33009
- Forest Investigative Site
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Jacksonville, Florida, United States, 32216
- Forest Investigative Site
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Orlando, Florida, United States, 32806
- Forest Investigative Site
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West Palm Beach, Florida, United States, 33407
- Forest Investigative Site
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Illinois
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Hoffman Estates, Illinois, United States, 60169
- Forest Investigative Site
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Kansas
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Wichita, Kansas, United States, 67206
- Forest Investigative Site
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Maryland
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Baltimore, Maryland, United States, 21285
- Forest Investigative Site
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Rockville, Maryland, United States, 20852
- Forest Investigative Site
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New Jersey
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Cherry Hill, New Jersey, United States, 08002
- Forest Investigative Site
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Willingboro, New Jersey, United States, 08046
- Forest Investigative Site
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New York
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Brooklyn, New York, United States, 11235
- Forest Investigative Site
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Mt. Kisco, New York, United States, 10549
- Forest Investigative Site
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New York, New York, United States, 10003
- Forest Investigative Site
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New York, New York, United States, 10021
- Forest Investigative Site
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Staten Island, New York, United States, 10312
- Forest Investigative Site
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North Carolina
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Raleigh, North Carolina, United States, 27607
- Forest Investigative Site
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Ohio
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Canton, Ohio, United States, 44718
- Forest Investigative Site
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Oregon
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Portland, Oregon, United States, 97210
- Forest Investigative Site
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Pennsylvania
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Media, Pennsylvania, United States, 19063
- Forest Investigative Site
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Norristown, Pennsylvania, United States, 19403
- Forest Investigative Site
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Rhode Island
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Lincoln, Rhode Island, United States, 02865
- Forest Investigative Site
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Tennessee
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Memphis, Tennessee, United States, 38119
- Forest Investigative Site
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Texas
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Dallas, Texas, United States, 75230
- Forest Investigative Site
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Dallas, Texas, United States, 75231
- Forest Investigative Site
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San Antonio, Texas, United States, 78229
- Forest Investigative Site
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Washington
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Bellevue, Washington, United States, 98007
- Forest Investigative Site
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Seattle, Washington, United States, 98104
- Forest Investigative Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men and women, 18-65 years old
- Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
- The patient's current depressive episode must be at least 8 weeks in duration
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:
- any manic or hypomanic episode
- schizophrenia or any other psychotic disorder
- obsessive-compulsive disorder
- Patients who are considered a suicide risk
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
40 mg Levomilnacipran ER capsules, low dose, oral administration, once daily.
|
Levomilnacipran ER, 40 mg, oral administration, in capsule form, once daily for 8 weeks.
Levomilnacipran ER, 80 mg, oral administration, in capsule form, once daily for 8 weeks.
Levomilnacipran ER, 120 mg, oral administration, in capsule form, once daily for 8 weeks.
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Experimental: 2
80 mg Levomilnacipran ER capsules, medium dose, oral administration, once daily dosing
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Levomilnacipran ER, 40 mg, oral administration, in capsule form, once daily for 8 weeks.
Levomilnacipran ER, 80 mg, oral administration, in capsule form, once daily for 8 weeks.
Levomilnacipran ER, 120 mg, oral administration, in capsule form, once daily for 8 weeks.
|
Experimental: 3
120 mg Levomilnacipran ER capsules, high dose, oral administration, once daily dosing
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Levomilnacipran ER, 40 mg, oral administration, in capsule form, once daily for 8 weeks.
Levomilnacipran ER, 80 mg, oral administration, in capsule form, once daily for 8 weeks.
Levomilnacipran ER, 120 mg, oral administration, in capsule form, once daily for 8 weeks.
|
Placebo Comparator: 4
Matching placebo capsules, oral administration, once daily.
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Matching placebo capsules, oral administration, once daily for 8 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Time Frame: From Baseline to Week 8
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Sheehan Disability Scale (SDS) Total Score
Time Frame: From Baseline to Week 8
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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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From Baseline to Week 8
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Carl Gommoll, MS, Forest Research Institute, a subsidiary of Forest Laboratories Inc.
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Mood Disorders
- Depression
- Depressive Disorder
- Disease
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Serotonin and Noradrenaline Reuptake Inhibitors
- Milnacipran
- Levomilnacipran
Other Study ID Numbers
- LVM-MD-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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