Safety Study of F2695 SR in Major Depressive Disorder

Phase 3

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: F2695 SR

• Registration Number: NCT01034267
• Lead Sponsor: Forest Laboratories

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-16
• Study First Submitted QC: 2009-12-16
• Study First Posted: 2009-12-17
• Primary Completion: 2012-06
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-15
• Last Update Posted: 2012-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 828

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	F2695 SR	(Open-label) F2695 SR capsules, oral administration, once daily, flexible dosing

Primary Outcome Measures

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

Trial Locations

Locations (68)

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

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