Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder

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Forest Laboratories

Status and phase

Completed
Phase 3

Conditions

Major Depressive Disorder

Treatments

Drug: Placebo
Drug: Levomilnacipran ER

Study type

Interventional

Funder types

Industry

Identifiers

NCT01034462
LVM-MD-03

Details and patient eligibility

About

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

Enrollment

442 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Men and women, 18-80 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: a. any manic or hypomanic episode; b. schizophrenia or any other psychotic disorder; c. obsessive-compulsive disorder.
  • Patients who are considered a suicide risk

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

442 participants in 2 patient groups, including a placebo group

1
Experimental group
Description:
Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing.
Treatment:
Drug: Levomilnacipran ER
2
Placebo Comparator group
Description:
Matching placebo capsules, oral administration, once daily dosing.
Treatment:
Drug: Placebo

Trial contacts and locations

23

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Data sourced from clinicaltrials.gov

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