Relapse-Prevention Study With Levomilnacipran ER (F2695 SR) in Patients With Major Depressive Disorder

NCT01085812 | Completed Phase 3 Results

• 1 other identifier: LVM-MD-05
• Study Type: interventional
• Target: 734
• Locations: 2 countries
• Sites: 35

Brief Summary

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).

Conditions

Depression; Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

2

EXPERIMENTAL

40, 80 or 120 mg/day Levomilnacipran ER capsules, oral administration, once daily dosing.

Drug: Levomilnacipran ER

1

PLACEBO COMPARATOR

Matching placebo capsules, oral administration, once daily dosing.

Drug: Placebo

Interventions

Levomilnacipran ER DRUG

Drug: Levomilnacipran ER (40, 80 or 120 mg/day) Study drug is to be given orally, in capsule form, once daily.

2

Placebo DRUG

Matching placebo to be given orally, in capsule form, once daily.

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 4 weeks in duration

You may not qualify if:

• 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

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (35)

Forest Investigative Site #023

Beverly Hills, California, 90210, United States

Location

Forest Investigative Site #017

Encino, California, 31316, United States

Location

Forest Investigative Site #021

Garden Grove, California, 92845, United States

Location

Forest Investigative Site #025

Newport Beach, California, 92660, United States

Location

Forest Investigative Site #030

Orange, California, 92868, United States

Location

Forest Investigative Site #002

San Diego, California, 92108, United States

Location

Forest Investigative Site #003

Sherman Oaks, California, 91403, United States

Location

Forest Research Institute #001

Bonita Springs, Florida, 34134, United States

Location

Forest Investigative Site #015

Fort Myers, Florida, 33912, United States

Location

Forest Investigative Site #029

Maitland, Florida, 32751, United States

Location

Forest Investigative Site #005

North Miami, Florida, 33161, United States

Location

Forest Investigative Site #016

Orlando, Florida, 32806, United States

Location

Forest Investigative Site #004

South Miami, Florida, 33143, United States

Location

Forest Investigative Site #014

Atlanta, Georgia, 30328, United States

Location

Forest Investigative Site #022

Chicago, Illinois, 60634, United States

Location

Forest Investigative Site #006

Chicago, Illinois, 60640, United States

Location

Forest Investigative Site #009

Prairie Village, Kansas, 66206, United States

Location

Forest Investigative Site #013

Baltimore, Maryland, 21208, United States

Location

Forest Investigative Site #010

Boston, Massachusetts, 02135, United States

Location

Forest Investigative Site #012

St Louis, Missouri, 63139, United States

Location

Forest Investigative Site #011

Staten Island, New York, 10312, United States

Location

Forest Investigative Site #026

Portland, Oregon, 97210, United States

Location

Forest Investigative Site #008

Bridgeville, Pennsylvania, 15017, United States

Location

Forest Investigative Site #028

Norristown, Pennsylvania, 19401, United States

Location

Forest Investigative Site #020

Philadelphia, Pennsylvania, 19139, United States

Location

Forest Investigative Site #024

Memphis, Tennessee, 38119, United States

Location

Forest Investigative Site #007

Dallas, Texas, 75231, United States

Location

Forest Investigative Site #019

San Antonio, Texas, 78229, United States

Location

Forest Investigative Site #018

Bellevue, Washington, 98007, United States

Location

Forest Investigative Site #027

Seattle, Washington, 98104, United States

Location

Forest Investigative Site #050

Kelowna, British Columbia, V1Y 1Z9, Canada

Location

Forest Investigative Site #051

Vancouver, British Columbia, V6Z 2L4, Canada

Location

Forest Investigative Site #052

Sydney, Nova Scotia, B1S 2E8, Canada

Location

Forest Investigative Site #055

Chatham, Ontario, N7M 1B7, Canada

Location

Forest Investigative Site #053

Ottawa, Ontario, K1G 4G3, Canada

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Interventions

Levomilnacipran

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Milnacipran; Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

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.

Results Point of Contact

• Title: Carl Gommoll, MS, Sr. Dir. Clinical Development Psychiatry
• Organization: Forest Research Institute

carl.gommoll@frx.com

201-427-8000

Study Officials

• Giovanna Forero, MA

  Forest Laboratories

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2010
• First Posted: March 12, 2010
• Study Start: March 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 13, 2020
• Results First Posted: January 13, 2020

Record last verified: 2019-12

Locations

CA (5); US (30)