Safety and Efficacy of F2695 SR in Adults With Fatigue Associated With Major Depressive Disorder
This study has been completed.
Sponsor:
Forest Laboratories
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01254305
First received: December 3, 2010
Last updated: July 25, 2012
Last verified: July 2012
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Purpose
The purpose of the study is to evaluate the efficacy, safety and tolerability of F2695 sustained release (SR) for the treatment of fatigue associated with major depressive disorder (MDD).
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder |
Drug: F2695 SR Drug: Paroxetine, Sertraline, or Fluoxetine Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-blind, Randomized, Placebo- and Active-Controlled Study of F2695 SR in Adult Patients With Fatigue Associated With Major Depressive Disorder |
Resource links provided by NLM:
Drug Information available for:
Serotonin
Fluoxetine
Fluoxetine hydrochloride
Paroxetine
Paroxetine hydrochloride
Sertraline hydrochloride
Sertraline
Paroxetine hydrochloride hemihydrate
Paroxetine Mesylate
U.S. FDA Resources
Further study details as provided by Forest Laboratories:
Primary Outcome Measures:
- Clinical Global Impression of Severity (CGI-S) for Fatigue [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Patient Global Impressions of Severity (PGI-S) for Fatigue [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Cognitive and Physical Functioning Questionnaire (CPFQ) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 262 |
| Study Start Date: | April 2011 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
40 -120 mg/day F2695 SR capsules, oral administration
|
Drug: F2695 SR
Drug: F2695 SR (40 -120 mg/day) Study drug is to be given orally, in capsule form, once daily for 8 weeks
|
|
Active Comparator: 2
Randomized to treatment with 1 of 3 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Fluoxetine Oral administration, once daily dosing
|
Drug: Paroxetine, Sertraline, or Fluoxetine
Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks
|
|
Placebo Comparator: 3
Matching placebo capsules, oral administration
|
Drug: Placebo
Matching placebo capsules, oral administration, once daily dosing
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men and women, 18-65 years old
- Currently meet 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 of child-bearing potential who are not practicing a reliable method of birth control
- Patients with a history of meeting DSM-IV-TR criteria for: a. any manic or hypomanic episode; b. schizophrenia or any other psychotic disorder; c. obsessive-compulsive disorder.
- Patients who are considered a suicide risk
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01254305
Locations
| United States, Alabama | |
| Forest Investigative Site 010 | |
| Birmingham, Alabama, United States, 35216 | |
| United States, Arkansas | |
| Forest Investigative Site 002 | |
| Little Rock, Arkansas, United States, 72223 | |
| United States, California | |
| Forest Investigative Site 001 | |
| Cerritos, California, United States, 90703 | |
| United States, Florida | |
| Forest Investigative Site 014 | |
| Fort Myers, Florida, United States, 33912 | |
| Forest Investigative Site 006 | |
| Jacksonville, Florida, United States, 32216 | |
| Forest Investigative Site 017 | |
| Orange City, Florida, United States, 32763 | |
| Forest Investigative Site 005 | |
| Orlando, Florida, United States, 32806 | |
| Forest Investigative Site 012 | |
| Tampa, Florida, United States, 33613 | |
| United States, Georgia | |
| Forest Investigative Site 009 | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Illinois | |
| Forest Investigative Site 016 | |
| Joliet, Illinois, United States, 60435 | |
| United States, Louisiana | |
| Forest Investigative Site 004 | |
| New Orleans, Louisiana, United States, 70122 | |
| United States, Massachusetts | |
| Forest Investigative Site 022 | |
| Boston, Massachusetts, United States, 02135 | |
| United States, New York | |
| Forest Investigative Site 011 | |
| Bronx, New York, United States, 10467 | |
| Forest Investigative Site 015 | |
| Cedarhurst, New York, United States, 11516 | |
| United States, Ohio | |
| Forest Investigative Site 003 | |
| Cincinnati, Ohio, United States, 45227 | |
| Forest Investigative Site 013 | |
| Dayton, Ohio, United States, 45417 | |
| United States, Rhode Island | |
| Forest Investigative Site 020 | |
| Lincoln, Rhode Island, United States, 02865 | |
| United States, Tennessee | |
| Forest Investigative Site 018 | |
| Memphis, Tennessee, United States, 38119 | |
| United States, Texas | |
| Forest Investigative Site 008 | |
| Dallas, Texas, United States, 75235 | |
| United States, Wisconsin | |
| Forest Investigative Site 007 | |
| Middleton, Wisconsin, United States, 53562 | |
Sponsors and Collaborators
Forest Laboratories
Investigators
| Study Director: | Carl Gommoll, MS | Forest Laboratories |
More Information
No publications provided
| Responsible Party: | Forest Laboratories |
| ClinicalTrials.gov Identifier: | NCT01254305 History of Changes |
| Other Study ID Numbers: | LVM-MD-06 |
| Study First Received: | December 3, 2010 |
| Last Updated: | July 25, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Forest Laboratories:
|
Depression Fatigue Major Depressive Disorder |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Fatigue Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Signs and Symptoms Fluoxetine Paroxetine Sertraline Serotonin Uptake Inhibitors |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013