MedDataX Logo

A Multicenter, Relapse Prevention Study With Levomilnacipran Extended Release (ER) in Participants With Major Depressive Disorder

NCT ID: NCT02288325

Last Updated: 2018-10-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

644 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-18

Study Completion Date

2016-09-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy of Levomilnacipran ER (Levomilnacipran SR) in Major Depressive Disorder

NCT01377194

Major Depressive Disorder
COMPLETED PHASE3

Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder

NCT01034462

Major Depressive Disorder
COMPLETED PHASE3

Safety and Efficacy of Levomilnacipran ER in Adolescent Participants With Major Depressive Disorder

NCT02431806

Major Depressive Disorder
COMPLETED PHASE3

Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder

NCT00969709

Major Depressive Disorder
COMPLETED PHASE3

Escitalopram in Adult Patients With Major Depressive Disorder

NCT00668525

Major Depressive Disorder
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depressive Disorder, Major

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Open-Label FETZIMA®

FETZIMA® (levomilnacipran extended release \[ER\]) taken orally during flexible dose titration up to 40, 80 or 120 mg once daily in 8-week run-in period followed by fixed dose of 40, 80 or 120 mg once daily in 12-week stabilization period.

Group Type EXPERIMENTAL

Levomilnacipran ER

Intervention Type DRUG

Levomilnacipran ER taken orally at 40, 80 or 120 mg once daily.

Double-Blind Placebo

Dose-matched placebo taken orally once daily for 26 weeks during double-blind treatment period.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dose-matched placebo taken orally once daily.

Double-Blind FETZIMA®

FETZIMA® (levomilnacipran ER) taken orally at fixed dose of 40, 80 or 120 mg once daily for 26 weeks during double-blind treatment period.

Group Type EXPERIMENTAL

Levomilnacipran ER

Intervention Type DRUG

Levomilnacipran ER taken orally at 40, 80 or 120 mg once daily.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Levomilnacipran ER

Levomilnacipran ER taken orally at 40, 80 or 120 mg once daily.

Intervention Type DRUG

Placebo

Dose-matched placebo taken orally once daily.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

FETZIMA®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Forest Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Raffaele Migliore

Role: STUDY_DIRECTOR

Forest Research Institute, Inc., an affiliate of Allergan, plc

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Forest Investigative Site 053

Birmingham, Alabama, United States

Site Status

Forest Investigative Site 050

Dothan, Alabama, United States

Site Status

Forest Investigative Site 039

Phoenix, Arizona, United States

Site Status

Forest Investigative Site 048

Beverly Hills, California, United States

Site Status

Forest Investigative Site 047

Chino, California, United States

Site Status

Forest Investigative Site 028

Costa Mesa, California, United States

Site Status

Forest Investigative Site 021

Encino, California, United States

Site Status

Forest Investigative Site 052

Lemon Grove, California, United States

Site Status

Forest Investigative Site 042

Oceanside, California, United States

Site Status

Forest Investigative Site 016

Sherman Oaks, California, United States

Site Status

Forest Investigative Site 037

Sherman Oaks, California, United States

Site Status

Forest Investigative Site 043

Simi Valley, California, United States

Site Status

Forest Investigative Site 040

Cromwell, Connecticut, United States

Site Status

Forest Investigative Site 038

Norwich, Connecticut, United States

Site Status

Forest Investigative Site 023

Bradenton, Florida, United States

Site Status

Forest Investigative Site 018

Fort Myers, Florida, United States

Site Status

Forest Investigative Site 001

Jacksonville, Florida, United States

Site Status

Forest Investigative Site 008

Jacksonville Beach, Florida, United States

Site Status

Forest Investigative Site 057

Kissimmee, Florida, United States

Site Status

Forest Investigative Site 009

Orlando, Florida, United States

Site Status

Forest Investigative Site 045

West Palm Beach, Florida, United States

Site Status

Forest Investigative Site 034

Alpharetta, Georgia, United States

Site Status

Forest Investigative Site 049

Smyrna, Georgia, United States

Site Status

Forest Investigative Site 019

Schaumburg, Illinois, United States

Site Status

Forest Investigative Site 020

Methuen, Massachusetts, United States

Site Status

Forest Investigative Site 051

Watertown, Massachusetts, United States

Site Status

Forest Investigative Site 044

Cherry Hill, New Jersey, United States

Site Status

Forest Investigative Site 031

Brooklyn, New York, United States

Site Status

Forest Investigative Site 036

Cedarhurst, New York, United States

Site Status

Forest Investigative Site 013

Mount Kisco, New York, United States

Site Status

Forest Investigative Site 003

New York, New York, United States

Site Status

Forest Investigative Site 005

New York, New York, United States

Site Status

Forest Investigative Site 055

Rochester, New York, United States

Site Status

Forest Investigative Site 058

Charlotte, North Carolina, United States

Site Status

Forest Investigative Site 011

Dayton, Ohio, United States

Site Status

Forest Investigative Site 035

Tulsa, Oklahoma, United States

Site Status

Forest Investigative Site 046

Portland, Oregon, United States

Site Status

Forest Investigative Site 041

Salem, Oregon, United States

Site Status

Forest Investigative Site 012

Media, Pennsylvania, United States

Site Status

Forest Investigative Site 030

Memphis, Tennessee, United States

Site Status

Forest Investigative Site 033

Memphis, Tennessee, United States

Site Status

Forest Investigative Site 054

Dallas, Texas, United States

Site Status

Forest Investigative Site 059

Houston, Texas, United States

Site Status

Forest Investigative Site 014

Murray, Utah, United States

Site Status

Forest Investigative Site 010

Charlottesville, Virginia, United States

Site Status

Forest Investigative Site 056

Roanoke, Virginia, United States

Site Status

Forest Investigative Site 026

Brown Deer, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LVM-MD-15

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
NCT07196501 RECRUITING PHASE3
Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric Patients (7-17 Years) With Major Depressive Disorder
NCT03569475 COMPLETED PHASE3
Study to Assess the Efficacy and Safety of NBI-1065845 in Adults With Major Depressive Disorder (MDD)
NCT05203341 COMPLETED PHASE2
Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
NCT06786624 RECRUITING PHASE3
Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)
NCT01111552 TERMINATED PHASE3
A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD)
NCT05081167 COMPLETED PHASE3
Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder
NCT00252330 COMPLETED PHASE3
Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
NCT06966401 RECRUITING PHASE3
A Study in Prevention of Re-emergence of Depression Symptoms
NCT01299272 COMPLETED PHASE3
Escitalopram Combination Comparison Study for Adult Patients With Major Depressive Disorder
NCT00239954 UNKNOWN PHASE3
A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)
NCT04688164 COMPLETED PHASE3
Levomilnacipran ER vs. Adjunctive Quetiapine for Adults With Inadequate Relief With SSRIs in MDD
NCT02720198 COMPLETED PHASE3
Long Term Treatment of Patients With Major Depressive Disorder With MK0869 (0869-065)(COMPLETED)
NCT00048594 COMPLETED PHASE3
Trial of Levomilnacipran in Geriatric Depression
NCT02466958 COMPLETED PHASE4
A Study in Adult Patients With Major Depressive Disorder
NCT00795821 COMPLETED PHASE2/PHASE3
NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
NCT06911112 RECRUITING PHASE3
Safety of REL-1017 for Major Depressive Disorder
NCT04855760 COMPLETED PHASE3
NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
NCT06963021 RECRUITING PHASE3
Treatment of Patients With Major Depressive Disorder With MK0869 (0869-061)
NCT00035295 COMPLETED PHASE3
A Safety and Efficacy Study of Escitalopram on Acute Treatment of Severe Depression
NCT01814085 COMPLETED PHASE4
Escitalopram in the Treatment of Dysthymic Disorder, Double Blind
NCT00220701 COMPLETED PHASE4
Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder
NCT00252356 COMPLETED PHASE3
Levomilnacipran in Healthy Males
NCT03249311 UNKNOWN PHASE4
A Trial Evaluating the Efficacy and Tolerability of SSR125543 in Outpatients With Major Depressive Disorder
NCT01034995 COMPLETED PHASE2
Study to Evaluate Efficacy and Safety of Ropanicant in MDD Patients
NCT06836063 ACTIVE_NOT_RECRUITING PHASE2