Safety Study of F2695 SR in Major Depressive Disorder

A Long-Term, Open-label Extension Study of F2695 SR in Adult Patients With Major Depressive Disorder

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01034267

Acronym

LVM-MD-04

Enrollment

828

Registered

2009-12-17

Start date

2009-12-31

Completion date

Unknown

Last updated

2012-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

Depression, Major Depressive Disorder

Brief 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.

Interventions

DRUGF2695 SR

Drug F2695 SR (flexible dose) to be given orally in capsule form once daily

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Adverse events, clinical laboratory tests, vital sign measurements, electrocardiograms, physical examinations, Columbia-Suicide Severity Rating Scale	48 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026