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

Phase 3

Completed

• Conditions: Major Depressive Disorder; Depression
• Interventions: Drug: Levomilnacipran ER; Drug: Placebo

• Registration Number: NCT01085812
• Lead Sponsor: Forest Laboratories

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).

Detailed Description

Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with Levomilnacipran ER are randomized to continue Levomilnacipran ER or switch to placebo under double-blind conditions for up to 24 weeks of additional treatment.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-10
• Study First Submitted QC: 2010-03-11
• Study First Posted: 2010-03-12
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Disposition First Submitted: 2011-12-29
• Disposition First Submitted QC: 2011-12-29
• Disposition First Posted: 2012-01-04
• Results First Submitted: 2013-08-22
• Status Verified: 2019-12
• Results First Submitted QC: 2019-12-23
• Last Update Submitted: 2019-12-23
• Results First Posted: 2020-01-13
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 734

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 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Levomilnacipran ER	40, 80 or 120 mg/day Levomilnacipran ER capsules, oral administration, once daily dosing.
1	Placebo	Matching placebo capsules, oral administration, once daily dosing.

Primary Outcome Measures

Name	Time	Method
Time to Relapse (Days)	24 Weeks	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

Trial Locations

Locations (35)

Forest Investigative Site #002; 🇺🇸 San Diego, California, United States

Forest Investigative Site #003; 🇺🇸 Sherman Oaks, California, United States

Forest Research Institute #001; 🇺🇸 Bonita Springs, Florida, United States

Forest Investigative Site #015; 🇺🇸 Fort Myers, Florida, United States

Forest Investigative Site #014; 🇺🇸 Atlanta, Georgia, United States

Forest Investigative Site #006; 🇺🇸 Chicago, Illinois, United States

Forest Investigative Site #010; 🇺🇸 Boston, Massachusetts, United States

Forest Investigative Site #012; 🇺🇸 Saint Louis, Missouri, United States

Forest Investigative Site #011; 🇺🇸 Staten Island, New York, United States

Forest Investigative Site #008; 🇺🇸 Bridgeville, Pennsylvania, United States

Forest Investigative Site #020; 🇺🇸 Philadelphia, Pennsylvania, United States

Forest Investigative Site #024; 🇺🇸 Memphis, Tennessee, United States

Forest Investigative Site #027; 🇺🇸 Seattle, Washington, United States

Forest Investigative Site #052; 🇨🇦 Sydney, Nova Scotia, Canada

Forest Investigative Site #055; 🇨🇦 Chatham, Ontario, Canada

Forest Investigative Site #050; 🇨🇦 Kelowna, British Columbia, Canada

Forest Investigative Site #051; 🇨🇦 Vancouver, British Columbia, Canada

Forest Investigative Site #023; 🇺🇸 Beverly Hills, California, United States

Forest Investigative Site #025; 🇺🇸 Newport Beach, California, United States

Forest Investigative Site #016; 🇺🇸 Orlando, Florida, United States

Forest Investigative Site #013; 🇺🇸 Baltimore, Maryland, United States

Forest Investigative Site #017; 🇺🇸 Encino, California, United States

Forest Investigative Site #005; 🇺🇸 North Miami, Florida, United States

Forest Investigative Site #026; 🇺🇸 Portland, Oregon, United States

Forest Investigative Site #007; 🇺🇸 Dallas, Texas, United States

Forest Investigative Site #029; 🇺🇸 Maitland, Florida, United States

Forest Investigative Site #028; 🇺🇸 Norristown, Pennsylvania, United States

Forest Investigative Site #019; 🇺🇸 San Antonio, Texas, United States

Forest Investigative Site #053; 🇨🇦 Ottawa, Ontario, Canada

Forest Investigative Site #004; 🇺🇸 South Miami, Florida, United States

Forest Investigative Site #018; 🇺🇸 Bellevue, Washington, United States

Forest Investigative Site #009; 🇺🇸 Prairie Village, Kansas, United States

Forest Investigative Site #030; 🇺🇸 Orange, California, United States

Forest Investigative Site #022; 🇺🇸 Chicago, Illinois, United States

Forest Investigative Site #021; 🇺🇸 Garden Grove, California, United States