Vortioxetine for Treatment of Depressive Mood and Alcohol... | NCT04498897

Studies
Vortioxetine for Treatment of Depressive Mood and Alcohol Use

NCT04498897

Sponsor

Hanyang University Seoul Hospital

Status

Unknown status

Last Update Posted

Aug 5, 2020Actual

Enrollment

128Estimated

Phase

Phase 2

Conditions

Depressive Disorder, Major
Alcoholism

Interventions

Vortioxetine
Acamprosate

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 25, 2019Actual

Primary Completion Date

Apr 4, 2021Estimated

Completion Date

Apr 4, 2021Estimated

First Submitted Date

Jul 30, 2020

First Submission Date that Met QC Criteria

Jul 30, 2020

First Posted Date

Aug 5, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2020

Last Update Posted Date

Aug 5, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

128Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test group	Active Comparator	Vortioxetine + Acamprosate	Drug: Vortioxetine Drug: Acamprosate
Placebo Group	Placebo Comparator	Placebo + Acamprosate	Drug: Acamprosate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vortioxetine	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
K-MADRS	Korean-Version of the Montgomery-Asberg Depression Rating Scale	From baseline for 8 weeks

Secondary Outcomes

Measure	Description	Time Frame
OCDS-K	Korean version of the Obsessive Compulsive Drinking Scale	from baseline for 8 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Ji-eun Kim	Contact	82-2-2290-8422		eva.jieun.kim@gmail.com
Sungwon Roh	Contact	82-2-2290-8422		swroh@hanyang.ac.kr

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders
D019973	Alcohol-Related Disorders

ID	Term
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D013654	Taurine

ID	Term
D003865	Depressive Disorder, Major
D000437	Alcoholism