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

Primary Purpose

Depression, Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Levomilnacipran ER
Placebo
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Forest Investigative Site #023
  • Forest Investigative Site #017
  • Forest Investigative Site #021
  • Forest Investigative Site #025
  • Forest Investigative Site #030
  • Forest Investigative Site #002
  • Forest Investigative Site #003
  • Forest Research Institute #001
  • Forest Investigative Site #015
  • Forest Investigative Site #029
  • Forest Investigative Site #005
  • Forest Investigative Site #016
  • Forest Investigative Site #004
  • Forest Investigative Site #014
  • Forest Investigative Site #022
  • Forest Investigative Site #006
  • Forest Investigative Site #009
  • Forest Investigative Site #013
  • Forest Investigative Site #010
  • Forest Investigative Site #012
  • Forest Investigative Site #011
  • Forest Investigative Site #026
  • Forest Investigative Site #008
  • Forest Investigative Site #028
  • Forest Investigative Site #020
  • Forest Investigative Site #024
  • Forest Investigative Site #007
  • Forest Investigative Site #019
  • Forest Investigative Site #018
  • Forest Investigative Site #027
  • Forest Investigative Site #050
  • Forest Investigative Site #051
  • Forest Investigative Site #052
  • Forest Investigative Site #055
  • Forest Investigative Site #053

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

2

1

Arm Description

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

Matching placebo capsules, oral administration, once daily dosing.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 10, 2010
Last Updated
December 23, 2019
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01085812
Brief Title
Relapse-Prevention Study With Levomilnacipran ER (F2695 SR) in Patients With Major Depressive Disorder
Official Title
A Multicenter, Randomized, Double-blind, Placebo-Controlled, Relapse-Prevention Study With F2695 SR in Patients With Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
734 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Experimental
Arm Description
40, 80 or 120 mg/day Levomilnacipran ER capsules, oral administration, once daily dosing.
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Matching placebo capsules, oral administration, once daily dosing.
Intervention Type
Drug
Intervention Name(s)
Levomilnacipran ER
Intervention Description
Drug: Levomilnacipran ER (40, 80 or 120 mg/day) Study drug is to be given orally, in capsule form, once daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo to be given orally, in capsule form, once daily.
Primary Outcome Measure Information:
Title
Time to Relapse (Days)
Description
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
Time Frame
24 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanna Forero, MA
Organizational Affiliation
Forest Laboratories
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site #023
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Forest Investigative Site #017
City
Encino
State/Province
California
ZIP/Postal Code
31316
Country
United States
Facility Name
Forest Investigative Site #021
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Forest Investigative Site #025
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Forest Investigative Site #030
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Forest Investigative Site #002
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Forest Investigative Site #003
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Forest Research Institute #001
City
Bonita Springs
State/Province
Florida
ZIP/Postal Code
34134
Country
United States
Facility Name
Forest Investigative Site #015
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Forest Investigative Site #029
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Forest Investigative Site #005
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Forest Investigative Site #016
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Forest Investigative Site #004
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Forest Investigative Site #014
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Forest Investigative Site #022
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60634
Country
United States
Facility Name
Forest Investigative Site #006
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Forest Investigative Site #009
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
Facility Name
Forest Investigative Site #013
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
Forest Investigative Site #010
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Forest Investigative Site #012
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63139
Country
United States
Facility Name
Forest Investigative Site #011
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Forest Investigative Site #026
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Forest Investigative Site #008
City
Bridgeville
State/Province
Pennsylvania
ZIP/Postal Code
15017
Country
United States
Facility Name
Forest Investigative Site #028
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19401
Country
United States
Facility Name
Forest Investigative Site #020
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Forest Investigative Site #024
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Forest Investigative Site #007
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Forest Investigative Site #019
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Forest Investigative Site #018
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Forest Investigative Site #027
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Forest Investigative Site #050
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1Z9
Country
Canada
Facility Name
Forest Investigative Site #051
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2L4
Country
Canada
Facility Name
Forest Investigative Site #052
City
Sydney
State/Province
Nova Scotia
ZIP/Postal Code
B1S 2E8
Country
Canada
Facility Name
Forest Investigative Site #055
City
Chatham
State/Province
Ontario
ZIP/Postal Code
N7M 1B7
Country
Canada
Facility Name
Forest Investigative Site #053
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1G 4G3
Country
Canada

12. IPD Sharing Statement

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

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