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Vortioxetine for Treatment of Depressive Mood and Alcohol Use

Primary Purpose

Depressive Disorder, Major, Alcoholism

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Vortioxetine
Acamprosate
Sponsored by
Hanyang University Seoul Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hanyang USHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Test group

Placebo Group

Arm Description

Vortioxetine + Acamprosate

Placebo + Acamprosate

Outcomes

Primary Outcome Measures

K-MADRS
Korean-Version of the Montgomery-Asberg Depression Rating Scale

Secondary Outcome Measures

OCDS-K
Korean version of the Obsessive Compulsive Drinking Scale

Full Information

First Posted
July 30, 2020
Last Updated
July 30, 2020
Sponsor
Hanyang University Seoul Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04498897
Brief Title
Vortioxetine for Treatment of Depressive Mood and Alcohol Use
Official Title
A Randomized, Double-Blind, Placebo-Controlled Trial of Vortioxetine for Depressive Mood and Alcohol Use in Adults With Major Depressive Disorder and Alcohol Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 25, 2019 (Actual)
Primary Completion Date
April 4, 2021 (Anticipated)
Study Completion Date
April 4, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hanyang University Seoul Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major, Alcoholism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A randomized, placebo-controlled study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blinded study
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test group
Arm Type
Active Comparator
Arm Description
Vortioxetine + Acamprosate
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Placebo + Acamprosate
Intervention Type
Drug
Intervention Name(s)
Vortioxetine
Intervention Description
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
Intervention Name(s)
Acamprosate
Intervention Description
Baseline: Vortioxetine 10mg (or placebo) + Acamprosate First 2 weeks: Vortioxetine 5-10mg (or placebo) + Acamprosate Last 6 weeks: Vortioxetine 5-20mg (or placebo) + Acamprosate
Primary Outcome Measure Information:
Title
K-MADRS
Description
Korean-Version of the Montgomery-Asberg Depression Rating Scale
Time Frame
From baseline for 8 weeks
Secondary Outcome Measure Information:
Title
OCDS-K
Description
Korean version of the Obsessive Compulsive Drinking Scale
Time Frame
from baseline for 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ji-eun Kim
Phone
82-2-2290-8422
Email
eva.jieun.kim@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sungwon Roh
Phone
82-2-2290-8422
Email
swroh@hanyang.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sungwon Roh
Organizational Affiliation
swroh@hanyang.ac.kr
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hanyang USH
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roh Sungwon

12. IPD Sharing Statement

Learn more about this trial

Vortioxetine for Treatment of Depressive Mood and Alcohol Use

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