We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Relapse-Prevention Study With F2695 SR in Patients With Major Depressive Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01085812
First Posted: March 12, 2010
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Forest Laboratories
  Purpose
The purpose of this study is to evaluate the safety and efficacy of F2695 sustained release (SR) relative to placebo in the prevention of depression relapse in patients with major depressive disorder (MDD).

Condition Intervention Phase
Depression Major Depressive Disorder Drug: F2695 SR Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-Controlled, Relapse-Prevention Study With F2695 SR in Patients With Major Depressive Disorder

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • The primary outcome measure is the time to relapse (in days) during the double-blind treatment phase [ Time Frame: 24 Weeks ]

Enrollment: 348
Study Start Date: March 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2
40, 80 or 120 mg/day F2695 SR capsules, oral administration, once daily dosing.
Drug: F2695 SR
Drug: F2695 SR (40, 80 or 120 mg/day) Study drug is to be given orally, in capsule form, once daily.
Placebo Comparator: 1
Matching placebo capsules, oral administration, once daily dosing.
Drug: Placebo
Matching placebo to be given orally, in capsule form, once daily.

Detailed Description:
Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with F2695 SR are randomized to continue F2695 SR or switch to placebo under double-blind conditions for up to 24 weeks of additional treatment.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women, 18-65 years old
  • Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
  • The patient's current depressive episode must be at least 4 weeks in duration

Exclusion Criteria:

  • Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control
  • Patients with a history of meeting DSM-IV-TR criteria for:

    • any manic or hypomanic episode
    • schizophrenia or any other psychotic disorder
    • obsessive-compulsive disorder
  • Patients who are considered a suicide risk
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01085812


  Show 35 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Giovanna Forero, MA Forest Laboratories
  More Information

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01085812     History of Changes
Other Study ID Numbers: LVM-MD-05
First Submitted: March 10, 2010
First Posted: March 12, 2010
Last Update Posted: October 12, 2017
Last Verified: December 2011

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms