Safety Study of F2695 SR in Major Depressive Disorder (LVM-MD-04)

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: F2695 SR

Study type: Interventional

Funder types: Industry

Identifiers

NCT01034267

LVM-MD-04

Details and patient eligibility

About

The purpose of this study is to evaluate the long- term safety of F2695-SR in the treatment of adults with major depressive disorder.

Enrollment: 828 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completed 1 of the lead-in studies LVM-MD-01, LVM-MD-02, or LVM-MD-03
• Have normal examination findings at the final visit of the lead-in study
• Have a negative serum pregnancy test at the final visit of the lead-in study if a woman of child-bearing potential

Exclusion criteria

• Any exclusionary psychiatric or medical condition that developed during the lead in study
• Patients considered a suicide risk
• Women who are pregnant, breastfeeding, or planning to become during the study OR are sexually active and not currently using a medically acceptable method of contraception

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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828 participants in 1 patient group

1

Experimental group

Description:

(Open-label) F2695 SR capsules, oral administration, once daily, flexible dosing

Treatment:

Drug: F2695 SR