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

Forest Laboratories

Status and phase

Completed

Phase 3

Conditions

Major Depressive Disorder

Depression

Treatments

Drug: Levomilnacipran ER

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01085812

LVM-MD-05

Details and patient eligibility

About

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).

Full 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.

Enrollment

734 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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