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

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: Levomilnacipran ER; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01377194

LVM-MD-10

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER compared to placebo in patients with Major Depressive Disorder (MDD).

Enrollment: 568 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women, 18-75 years old
• Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
• The patient's current depressive episode must be at least 6 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 who are considered a suicide risk
• Patients with a history of meeting DSM-IV-TR criteria for
• a. any manic or hypomanic episode
• b. schizophrenia or any other psychotic disorder
• c. obsessive-compulsive disorder.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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568 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

40mg Levomilnacipran ER

Treatment:

Drug: Levomilnacipran ER

Drug: Levomilnacipran ER

2

Experimental group

Description:

80mg of Levomilnacipran ER

Treatment:

Drug: Levomilnacipran ER

Drug: Levomilnacipran ER

3

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo