- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00969150
Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder
A Double-blind, Placebo-Controlled, Flexible-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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Scottsdale, Arizona, United States, 85254
- Forest Investigative Site
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California
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Encino, California, United States, 91316
- Forest Investigative Site
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Los Alamitos, California, United States, 90720
- Forest Investigative Site
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Oceanside, California, United States, 92056
- Forest Investigative Site
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Colorado
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Denver, Colorado, United States, 80239
- Forest Investigative Site
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Denver, Colorado, United States, 80204
- Forest Investigative Site
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Florida
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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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Illinois
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Chicago, Illinois, United States, 60634
- 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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Glen Burnie, Maryland, United States, 21061
- Forest Investigative Site
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Massachusetts
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Fall River, Massachusetts, United States, 02721
- Forest Investigative Site
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Michigan
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East Lansing, Michigan, United States, 48824
- 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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New York
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Brooklyn, New York, United States, 11235
- 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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Ohio
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Canton, Ohio, United States, 44718
- Forest Investigative Site 013
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Dayton, Ohio, United States, 45417
- 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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Philadelphia, Pennsylvania, United States, 19107
- 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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Vermont
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Woodstock, Vermont, United States, 05091
- 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, 18-80 years old
- Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
- The patient's current depressive episode must be at least 4 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
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: 2
Matching placebo capsules, oral administration, once daily dosing.
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Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.
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EXPERIMENTAL: 1
Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing.
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Drug: Levomilnacipran ER (flexible dose) Study drug is to be given orally, in capsule form, 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-Asberg Depression Rating Scale (MADRS) Total Score
Time Frame: From Baseline to Week 8
|
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
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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 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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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.
- Gommoll CP, Greenberg WM, Chen C. A randomized, double-blind, placebo-controlled study of flexible doses of levomilnacipran ER (40-120 mg/day) in patients with major depressive disorder. J Drug Assess. 2014 Jan 16;3(1):10-9. doi: 10.3109/21556660.2014.884505. eCollection 2014.
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-02
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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