Vortioxetine for Treatment of Depressive Mood and Alcohol Use
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Alcoholism
- Depressive Disorder, Major
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: A randomized, placebo-controlled studyMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Double-blinded studyPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 19 years and 65 years
- Gender
- Both males and females
Description
Investigational product baseline: Vortioxetine 10mg (or placebo) qd + Acamprosate* First 2 weeks: Vortioxetine 5-10mg (or placebo) qd+ Acamprosate* Last 6 weeks: Vortioxetine 5-20mg (or placebo) qd + Acamprosate* Acamprosate 666 mg bid for bodyweight < 60 kg; Acamprosate 666 mg tid for bodyweight ? ...
Investigational product baseline: Vortioxetine 10mg (or placebo) qd + Acamprosate* First 2 weeks: Vortioxetine 5-10mg (or placebo) qd+ Acamprosate* Last 6 weeks: Vortioxetine 5-20mg (or placebo) qd + Acamprosate* Acamprosate 666 mg bid for bodyweight < 60 kg; Acamprosate 666 mg tid for bodyweight ? 60 kg
Tracking Information
- NCT #
- NCT04498897
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Sungwon Roh swroh@hanyang.ac.kr
Get Well Soon