NCT04498897

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 5, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2021

Completed
Last Updated

August 5, 2020

Status Verified

July 1, 2020

Enrollment Period

2.2 years

First QC Date

July 30, 2020

Last Update Submit

July 30, 2020

Conditions

Depressive Disorder, MajorAlcoholism

Outcome Measures

Primary Outcomes (1)

  • K-MADRS

    Korean-Version of the Montgomery-Asberg Depression Rating Scale

    From baseline for 8 weeks

Secondary Outcomes (1)

  • OCDS-K

    from baseline for 8 weeks

Study Arms (2)

Test group

ACTIVE COMPARATOR

Vortioxetine + Acamprosate

Drug: VortioxetineDrug: Acamprosate

Placebo Group

PLACEBO COMPARATOR

Placebo + Acamprosate

Drug: Acamprosate

Interventions

VortioxetineDRUG

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

Test group
AcamprosateDRUG

* 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 GroupTest group

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanyang USH

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, MajorAlcoholism

Interventions

VortioxetineAcamprosate

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTaurineAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Sungwon Roh

    swroh@hanyang.ac.kr

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ji-eun Kim

CONTACT

82-2-2290-8422eva.jieun.kim@gmail.com

Sungwon Roh

CONTACT

82-2-2290-8422swroh@hanyang.ac.kr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-blinded study
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized, placebo-controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 30, 2020

First Posted

August 5, 2020

Study Start

January 25, 2019

Primary Completion

April 4, 2021

Study Completion

April 4, 2021

Last Updated

August 5, 2020

Record last verified: 2020-07

Locations

KR(1)