Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Adults With Fatigue Associated With Major Depressive Disorder

Forest Laboratories

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: Levomilnacipran ER; Drug: Placebo; Drug: Paroxetine, Sertraline, Citalopram or Fluoxetine.

Study type: Interventional

Funder types: Industry

Identifiers

NCT01254305

LVM-MD-06

Details and patient eligibility

About

The purpose of the study is to evaluate the efficacy, safety and tolerability of Levomilnacipran ER for the treatment of fatigue associated with major depressive disorder (MDD).

Enrollment: 262 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women, 18-65 years old
• Currently meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (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 of child-bearing potential who are not practicing a reliable method of birth control

• Patients with a history of meeting DSM-IV-TR criteria for:

  1. any manic or hypomanic episode;
  2. schizophrenia or any other psychotic disorder;
  3. obsessive-compulsive disorder.

• Patients who are considered a suicide risk

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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262 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

40 -120 mg/day Levomilnacipran ER capsules, oral administration

Treatment:

Drug: Levomilnacipran ER

2

Active Comparator group

Description:

Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine Oral administration, once daily dosing

Treatment:

Drug: Paroxetine, Sertraline, Citalopram or Fluoxetine.

3

Placebo Comparator group

Description:

Matching placebo capsules, oral administration

Treatment:

Drug: Placebo