Safety Study of F2695 SR in Major Depressive Disorder

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories

Criteria

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