Vortioxetine for Treatment of Depressive Mood and Alcohol Use

NCT ID: NCT04498897

Last Updated: 2020-08-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-25
• Study Completion Date: 2021-04-04

Brief Summary

This is a randomized, double-blinded, placebo-controlled, multicenter study. A total of 128 subjects will be randomly assigned to a test group or placebo group in a 1:1 ratio. Subjects will receive vortioxetine (or placebo) and acamprosate for 6 weeks according to the treatment group. Four visits will be made (weeks 0, 2, 4, 8), and on visit 2-4 (weeks 2, 4, 8) compliance, depression symptoms, and alcohol craving will be assessed.

Detailed 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 ≥ 60 kg

Conditions

Depressive Disorder, Major; Alcoholism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Test group

Vortioxetine + Acamprosate

Group Type: ACTIVE_COMPARATOR

Vortioxetine

Intervention Type: DRUG

• Baseline: Vortioxetine 10mg (or placebo) + Acamprosate
• First 2 weeks: Vortioxetine 5-10mg (or placebo) + Acamprosate
• Last 6 weeks: Vortioxetine 5-20mg (or placebo) + Acamprosate

Acamprosate

Intervention Type: DRUG

• Baseline: Vortioxetine 10mg (or placebo) + Acamprosate
• First 2 weeks: Vortioxetine 5-10mg (or placebo) + Acamprosate
• Last 6 weeks: Vortioxetine 5-20mg (or placebo) + Acamprosate

Placebo Group

Placebo + Acamprosate

Group Type: PLACEBO_COMPARATOR

Acamprosate

Intervention Type: DRUG

• Baseline: Vortioxetine 10mg (or placebo) + Acamprosate
• First 2 weeks: Vortioxetine 5-10mg (or placebo) + Acamprosate
• Last 6 weeks: Vortioxetine 5-20mg (or placebo) + Acamprosate

Interventions

Vortioxetine

• Baseline: Vortioxetine 10mg (or placebo) + Acamprosate
• First 2 weeks: Vortioxetine 5-10mg (or placebo) + Acamprosate
• Last 6 weeks: Vortioxetine 5-20mg (or placebo) + Acamprosate

Intervention Type: DRUG

Acamprosate

• Baseline: Vortioxetine 10mg (or placebo) + Acamprosate
• First 2 weeks: Vortioxetine 5-10mg (or placebo) + Acamprosate
• Last 6 weeks: Vortioxetine 5-20mg (or placebo) + Acamprosate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects who are able to understand the study and comply with all study procedures and willing to provide written informed consent prior to screening
• Male and female subjects aged 19 to 65 years old
• Diagnosed to have major depressive disorder and alcohol use disorder based on DSM(Diagnostic and Statistical Manual of Mental Disorders)-5 by two separate psychiatrists.
• MADRS(Montgomery Åsberg Depression Rating Scale) ≥ 26 at baseline

Exclusion Criteria

• Subjects considered not safe to participate in the study (e.g. who has suicidal thoughts)
• Pregnant or breastfeeding
• Subjects with serious or unstable disease
• Clinical or laboratory signs of on-going hypothyroidism
• History of organic mental disorder, schizophrenia spectrum disorder, bipolar disorder, or substance abuse within 12 months (except for alcohol or nicotine abuse)
• Administration of antidepressant (MAOIs, SSRIs, SNRIs, TCAs) including vortioxetine and anti-craving medications (acamprosate, naltrexone) within 2 weeks from screening
• Administration of antipsychotic, anti-manic drugs, dopamine antagonists, anxiolytics (zolpidem more than 10mg, Benzodiazepine lorazepam equivalent dosage more than 2mg or used as alcohol withdrawal treatment) within 2 weeks from screening
• Administration of anti-depressant, fluoxetine, within 5 weeks from screening
• Subjects in need of an alcohol detoxification treatment
• Subjects in need of a hospitalization care

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanyang University Seoul Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sungwon Roh

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sungwon Roh

Role: PRINCIPAL_INVESTIGATOR

swroh@hanyang.ac.kr

Locations

Hanyang USH

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Ji-eun Kim

Role: CONTACT

eva.jieun.kim@gmail.com

82-2-2290-8422

Sungwon Roh

Role: CONTACT

swroh@hanyang.ac.kr

82-2-2290-8422

Facility Contacts

Roh Sungwon

Role: primary

Other Identifiers

VTX-RCT

Identifier Type: -

Identifier Source: org_study_id