Safety and Efficacy of Levomilnacipran ER (F2695 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

NCT00969709

LVM-MD-01

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER fixed doses versus placebo in the treatment of outpatients with major depressive disorder.

Enrollment: 724 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 8 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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724 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

40 mg Levomilnacipran ER capsules, low dose, oral administration, once daily.

Treatment:

Drug: Levomilnacipran ER

Drug: Levomilnacipran ER

Drug: Levomilnacipran ER

2

Experimental group

Description:

80 mg Levomilnacipran ER capsules, medium dose, oral administration, once daily dosing

Treatment:

Drug: Levomilnacipran ER

Drug: Levomilnacipran ER

Drug: Levomilnacipran ER

3

Experimental group

Description:

120 mg Levomilnacipran ER capsules, high dose, oral administration, once daily dosing

Treatment:

Drug: Levomilnacipran ER

Drug: Levomilnacipran ER

Drug: Levomilnacipran ER

4

Placebo Comparator group

Description:

Matching placebo capsules, oral administration, once daily.

Treatment:

Drug: Placebo