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

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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)

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

Trial contacts and locations

68

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Data sourced from clinicaltrials.gov

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