Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder

• ClinicalTrials.gov Identifier: NCT00969150
• Recruitment Status: Completed
• First Posted: September 1, 2009
• Results First Posted: October 25, 2013
• Last Update Posted: October 25, 2013
• Sponsor: Forest Laboratories
• Information provided by (Responsible Party): Forest Laboratories

Tracking Information

• First Submitted Date: August 31, 2009
• First Posted Date: September 1, 2009
• Results First Submitted Date: August 22, 2013
• Results First Posted Date: October 25, 2013
• Last Update Posted Date: October 25, 2013
• Study Start Date: September 2009
• Actual Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 22, 2013)

Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: From Baseline to Week 8 ]

MADRS was used to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item of the 10 items are scored on a 7-point scale. A score of 0 indicates the absence of symptoms,and a score of 6 indicates symptoms of maximum severity. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 60 (maximum severity).

• Original Primary Outcome Measures (submitted: August 31, 2009): Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ]
• Change History: Complete list of historical versions of study NCT00969150 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: August 22, 2013)

Change in Sheehan Disability Scale (SDS) Total Score [ Time Frame: From Baseline to Week 8 ]

The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe)

• Original Secondary Outcome Measures (submitted: August 31, 2009): Sheehan Disability Scale (SDS) and Clinical Global Impressions - Improvement (CGI-I) [ Time Frame: 8 weeks ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder
• Official Title: A Double-blind, Placebo-Controlled, Flexible-Dose Study of F2695 SR in Patients With Major Depressive Disorder
• Brief Summary: The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER versus placebo in the treatment of outpatients with major depressive disorder.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Major Depressive Disorder

Intervention

• Drug: Levomilnacipran ER
  Drug: Levomilnacipran ER (flexible dose) Study drug is to be given orally, in capsule form, once daily, for 8 weeks.
• Drug: Placebo
  Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.

Study Arms

• Placebo Comparator: 2
  Matching placebo capsules, oral administration, once daily dosing.
  Intervention: Drug: Placebo
• Experimental: 1
  Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing.
  Intervention: Drug: Levomilnacipran ER

Publications *

• Cutler AJ, Gommoll CP, Chen C, Greenberg WM, Ruth A. Levomilnacipran Extended-Release Treatment in Patients With Major Depressive Disorder: Improvements in Functional Impairment Categories. Prim Care Companion CNS Disord. 2015 Jun 11;17(3). doi: 10.4088/PCC.14m01753. eCollection 2015.
• Gommoll CP, Greenberg WM, Chen C. A randomized, double-blind, placebo-controlled study of flexible doses of levomilnacipran ER (40-120 mg/day) in patients with major depressive disorder. J Drug Assess. 2014 Jan 16;3(1):10-9. doi: 10.3109/21556660.2014.884505. eCollection 2014.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 24, 2011): 362
• Original Estimated Enrollment (submitted: August 31, 2009): 360
• Study Completion Date: Not Provided
• Actual Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Men and women, 18-80 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00969150
• Other Study ID Numbers: LVM-MD-02
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Forest Laboratories
• Study Sponsor: Forest Laboratories
• Collaborators: Not Provided

Investigators

• Study Director: Carl Gommoll, MS; Forest Research Institute, a subsidiary of Forest Laboratories, Inc.

• PRS Account: Forest Laboratories
• Verification Date: August 2013