Levomilnacipran ER vs. Adjunctive Quetiapine for Adults With Inadequate Relief With SSRIs in MDD

PHASE3CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

January 23, 2017

Primary Completion Date

June 12, 2018

Study Completion Date

June 12, 2018

Conditions
Major Depressive Disorder
Interventions
DRUG

Levomilnacipran

treating major depression. A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8

DRUG

Quetiapine

Quetiapine will be started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current antidepressant.

Trial Locations (1)

30005

Institute for Advanced Medical Research, Alpharetta

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Forest Laboratories

INDUSTRY

collaborator

Institute for Advanced Medical Research, Alpharetta, GA

OTHER

lead

Duke University

OTHER