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

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER fixed doses versus placebo in the treatment of outpatients with major depressive disorder.

Official Title
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A Double-blind, Placebo-Controlled, Fixed-Dose Study of F2695 SR in Patients With Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Levomilnacipran ER
* Drug: Levomilnacipran ER
* Drug: Levomilnacipran ER
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 8 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>40 mg Levomilnacipran ER capsules, low dose, oral administration, once daily. | Drug: Levomilnacipran ER<br>* Levomilnacipran ER, 40 mg, oral administration, in capsule form, once daily for 8 weeks.<br>|
| Experimental: 2<br>80 mg Levomilnacipran ER capsules, medium dose, oral administration, once daily dosing | Drug: Levomilnacipran ER<br>* Levomilnacipran ER, 80 mg, oral administration, in capsule form, once daily for 8 weeks.<br>|
| Experimental: 3<br>120 mg Levomilnacipran ER capsules, high dose, oral administration, once daily dosing | Drug: Levomilnacipran ER<br>* Levomilnacipran ER, 120 mg, oral administration, in capsule form, once daily for 8 weeks.<br>|
| Placebo Comparator: 4<br>Matching placebo capsules, oral administration, once daily. | Drug: Placebo<br>* Matching placebo capsules, oral administration, once daily for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | The 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 for all measured symptoms). | From Baseline to Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sheehan Disability Scale (SDS) Total Score | The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate functional 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 for all measured symptoms) | From Baseline to Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Major Depressive Disorder