MedTrace Logo

Safety and Efficacy of MK-6096 as Adjunctive Therapy in Participants With Major Depressive Disorder And Partial Response to Antidepressant Monotherapy (MK-6096-022)

NCT01554176 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2018-11-07

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate the safety and efficacy of filorexant (MK-6096) versus placebo as adjunctive treatment for major depressive disorder (MDD), in participants who are partial responders to antidepressant monotherapy with one of identified selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), or bupropion. The primary hypothesis of the study is that filorexant is superior to placebo as augmentation therapy with respect to change from baseline to Week 6 in the Montgomery Asberg Depression Rating Scale (MADRS) total score.

Conditions

  • Major Depressive Disorder, Recurrent

Interventions

DRUG

Filorexant

Filorexant, one 10 mg tablet, orally, once daily at bedtime

DRUG

Placebo

Placebo, one tablet, orally, once daily at bedtime

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-18
Primary Completion
2013-09-03
Completion
2013-09-03

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01554176 on ClinicalTrials.gov