Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Adults With Fatigue Associated With Major Depressive Disorder

NCT01254305 | Completed Phase 2 Results

• 1 other identifier: LVM-MD-06
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 20

Brief Summary

The purpose of the study is to evaluate the efficacy, safety and tolerability of Levomilnacipran ER for the treatment of fatigue associated with major depressive disorder (MDD).

Conditions

Major Depressive Disorder

Keywords

Depression; Fatigue; Major Depressive Disorder

Outcome Measures

Primary Outcomes (2)

• Change in Clinical Global Impression of Severity (CGI-S) for Fatigue Score

  The CGI-S is a clinician-rated scale that rates the severity of the patient's current state of fatigue based on the Investigator's clinical opinion with regard to the patient population with Major Depressive Disorder (MDD). Patient were rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating that the patient was among the most extremely fatigued

  From Baseline to Week 8

• Change in Patient Global Impressions of Severity (PGI-S) for Fatigue Score

  The PGI-S is a clinician-rated scale that rates was used to rate the severity of the patient's current state of overall fatigue. Patients were rated on a scale from 1 to 7, with 1 indicating no symptoms of fatigue and 7 indicating extreme fatigue.

  From Baseline to Week 8

Secondary Outcomes (1)

• Change in Cognitive and Physical Functioning Questionnaire (CPFQ), Last Observation Carried Forward

  From Baseline to Week 8

Study Arms (3)

1

EXPERIMENTAL

40 -120 mg/day Levomilnacipran ER capsules, oral administration

Drug: Levomilnacipran ER

2

ACTIVE COMPARATOR

Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine Oral administration, once daily dosing

Drug: Paroxetine, Sertraline, Citalopram or Fluoxetine.

3

PLACEBO COMPARATOR

Matching placebo capsules, oral administration

Drug: Placebo

Interventions

Levomilnacipran ER DRUG

Drug: Levomilnacipran ER (40 -120 mg/day) Study drug is to be given orally, in capsule form, once daily for 8 weeks

1

Paroxetine, Sertraline, Citalopram or Fluoxetine. DRUG

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 Citalopram (20, 40, or 60 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

2

Placebo DRUG

Matching placebo capsules, oral administration, once daily dosing

3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, 18-65 years old
• Currently meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder
• The patient's current depressive episode must be at least 4 weeks in duration

You may not qualify if:

• 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:
• any manic or hypomanic episode;
• schizophrenia or any other psychotic disorder;
• obsessive-compulsive disorder.
• Patients who are considered a suicide risk

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (20)

Forest Investigative Site 010

Birmingham, Alabama, 35216, United States

Location

Forest Investigative Site 002

Little Rock, Arkansas, 72223, United States

Location

Forest Investigative Site 001

Cerritos, California, 90703, United States

Location

Forest Investigative Site 014

Fort Myers, Florida, 33912, United States

Location

Forest Investigative Site 006

Jacksonville, Florida, 32216, United States

Location

Forest Investigative Site 017

Orange City, Florida, 32763, United States

Location

Forest Investigative Site 005

Orlando, Florida, 32806, United States

Location

Forest Investigative Site 012

Tampa, Florida, 33613, United States

Location

Forest Investigative Site 009

Atlanta, Georgia, 30308, United States

Location

Forest Investigative Site 016

Joliet, Illinois, 60435, United States

Location

Forest Investigative Site 004

New Orleans, Louisiana, 70122, United States

Location

Forest Investigative Site 022

Boston, Massachusetts, 02135, United States

Location

Forest Investigative Site 015

Cedarhurst, New York, 11516, United States

Location

Forest Investigative Site 011

The Bronx, New York, 10467, United States

Location

Forest Investigative Site 003

Cincinnati, Ohio, 45227, United States

Location

Forest Investigative Site 013

Dayton, Ohio, 45417, United States

Location

Forest Investigative Site 020

Lincoln, Rhode Island, 02865, United States

Location

Forest Investigative Site 018

Memphis, Tennessee, 38119, United States

Location

Forest Investigative Site 008

Dallas, Texas, 75235, United States

Location

Forest Investigative Site 007

Middleton, Wisconsin, 53562, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Fatigue

Interventions

Levomilnacipran; Paroxetine; Sertraline; Citalopram; Fluoxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milnacipran; Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 1-Naphthylamine; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Propylamines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Carl Gommoll, MS, Sr. Dir. Clinical Development Psychiatry
• Organization: Forest Research Institute

carl.gommoll@frx.com

201-427-8000

Study Officials

• Carl Gommoll, MS

  Forest Laboratories

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2010
• First Posted: December 6, 2010
• Study Start: April 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 6, 2014
• Results First Posted: August 6, 2014

Record last verified: 2014-08

Locations

US (20)