Depressive Disorder, Major Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind, Placebo-Controlled, Relapse-Prevention Study With Levomilnacipran ER in Patients With Major Depressive Disorder
Verified date | September 2018 |
Source | Forest Laboratories |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates the efficacy, safety and tolerability of levomilnacipran extended-release (ER) compared with placebo in the prevention of depression relapse in major depressive disorder (MDD).
Status | Completed |
Enrollment | 644 |
Est. completion date | September 16, 2016 |
Est. primary completion date | September 16, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria - Currently meet the DMS-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) criteria for Major Depressive Disorder (MDD) - The participant must have an ongoing major depressive episode of at least 8 weeks and no more than 18 months - The participant must have at least 3 lifetime episodes of MDD (including the current episode) 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 - Participants who are considered a suicide risk - History of non-response to 2 or more antidepressants (after adequate treatment) - Participants who have a history of meeting DMS-5 criteria for manic, hypomanic, or mixed episode, obsessive-compulsive disorder, schizophrenia or other psychotic disorder - Panic disorder |
Country | Name | City | State |
---|---|---|---|
United States | Forest Investigative Site 034 | Alpharetta | Georgia |
United States | Forest Investigative Site 048 | Beverly Hills | California |
United States | Forest Investigative Site 053 | Birmingham | Alabama |
United States | Forest Investigative Site 023 | Bradenton | Florida |
United States | Forest Investigative Site 031 | Brooklyn | New York |
United States | Forest Investigative Site 026 | Brown Deer | Wisconsin |
United States | Forest Investigative Site 036 | Cedarhurst | New York |
United States | Forest Investigative Site 058 | Charlotte | North Carolina |
United States | Forest Investigative Site 010 | Charlottesville | Virginia |
United States | Forest Investigative Site 044 | Cherry Hill | New Jersey |
United States | Forest Investigative Site 047 | Chino | California |
United States | Forest Investigative Site 028 | Costa Mesa | California |
United States | Forest Investigative Site 040 | Cromwell | Connecticut |
United States | Forest Investigative Site 054 | Dallas | Texas |
United States | Forest Investigative Site 011 | Dayton | Ohio |
United States | Forest Investigative Site 050 | Dothan | Alabama |
United States | Forest Investigative Site 021 | Encino | California |
United States | Forest Investigative Site 018 | Fort Myers | Florida |
United States | Forest Investigative Site 059 | Houston | Texas |
United States | Forest Investigative Site 001 | Jacksonville | Florida |
United States | Forest Investigative Site 008 | Jacksonville Beach | Florida |
United States | Forest Investigative Site 057 | Kissimmee | Florida |
United States | Forest Investigative Site 052 | Lemon Grove | California |
United States | Forest Investigative Site 012 | Media | Pennsylvania |
United States | Forest Investigative Site 030 | Memphis | Tennessee |
United States | Forest Investigative Site 033 | Memphis | Tennessee |
United States | Forest Investigative Site 020 | Methuen | Massachusetts |
United States | Forest Investigative Site 013 | Mount Kisco | New York |
United States | Forest Investigative Site 014 | Murray | Utah |
United States | Forest Investigative Site 003 | New York | New York |
United States | Forest Investigative Site 005 | New York | New York |
United States | Forest Investigative Site 038 | Norwich | Connecticut |
United States | Forest Investigative Site 042 | Oceanside | California |
United States | Forest Investigative Site 009 | Orlando | Florida |
United States | Forest Investigative Site 039 | Phoenix | Arizona |
United States | Forest Investigative Site 046 | Portland | Oregon |
United States | Forest Investigative Site 056 | Roanoke | Virginia |
United States | Forest Investigative Site 055 | Rochester | New York |
United States | Forest Investigative Site 041 | Salem | Oregon |
United States | Forest Investigative Site 019 | Schaumburg | Illinois |
United States | Forest Investigative Site 016 | Sherman Oaks | California |
United States | Forest Investigative Site 037 | Sherman Oaks | California |
United States | Forest Investigative Site 043 | Simi Valley | California |
United States | Forest Investigative Site 049 | Smyrna | Georgia |
United States | Forest Investigative Site 035 | Tulsa | Oklahoma |
United States | Forest Investigative Site 051 | Watertown | Massachusetts |
United States | Forest Investigative Site 045 | West Palm Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Forest Laboratories |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to First Relapse During the Double-Blind Treatment Period (DBTP) | Time to relapse for the median was measured in days from randomization date at the start of the DBTP to relapse date during DBTP. Relapse was defined as meeting any 1 or more of the following criteria: 1) Insufficient therapeutic response at any one visit, including a >/= 2 increase in Clinical Global Impressions-Severity (CGI-S) score (range 1 to 7) compared with that obtained at randomization, or risk of suicide as determined by the investigator, or need for hospitalization due to worsening of depression as determined by the investigator, or need for alternative treatment of depressive symptoms as determined by the Investigator; 2) Montgomery-Asberg Depression Rating Scale (MADRS) total score >/= 18 (range 0 to 60) at 2 consecutive visits (second visit within 7 to 14 days after the first visit at which the MADRS total score was = 18). Participant was considered censored at the last visit during DBTP if participant did not meet the relapse criteria during DBTP. | From the randomization date (Week 20) to the relapse date during the 26-week DBTP (up to Week 46) |
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