Safety Study of F2695 SR in Major Depressive Disorder

Forest Laboratories828 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

828

Conditions

Major Depressive Disorder

Interventions

F2695 SRDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (68)

Outcomes

Primary Outcomes

Adverse events, clinical laboratory tests, vital sign measurements, electrocardiograms, physical examinations, Columbia-Suicide Severity Rating Scale

Time frame: 48 weeks

Data from ClinicalTrials.gov

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Forest Investigative Site 55

Dothan, Alabama, United States

Forest Investigative Site 29

Scottsdale, Arizona, United States

Forest Investigative Site 31

Beverly Hills, California, United States

Forest Investigative Site 3

Costa Mesa, California, United States

Forest Investigative Site 12

Encino, California, United States

Forest Investigative Site 6

Escondido, California, United States

Forest Investigative Site 22

Oceanside, California, United States

Forest Investigative Site 38

Sherman Oaks, California, United States

Forest Investigative Site 36

Denver, Colorado, United States

Forest Investigative Site 28

Denver, Colorado, United States

...and 58 more locations