Conditions: Major Depressive Disorder
Keywords: Depression Fatigue Major Depressive Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 262
Healthy volunteers: no

Brief summary:
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).

Detailed description:

Arms:
arm 1: 40 -120 mg/day Levomilnacipran ER capsules, oral administration arm 2: Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine Oral administration, once daily dosing arm 3: Matching placebo capsules, oral administration

Interventions: intervention 1: Levomilnacipran ER intervention 2: Paroxetine, Sertraline, Citalopram or Fluoxetine. intervention 3: Placebo
Intervention descriptions: intervention 1: Drug: Levomilnacipran ER (40 -120 mg/day) Study drug is to be given orally, in capsule form, once daily for 8 weeks intervention 2: Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks intervention 3: Matching placebo capsules, oral administration, once daily dosing

Protocol document: