Vortioxetine for Treatment of Depressive Mood and Alcohol Use

Depressive Disorder, Major Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04498897
• Other study ID #: VTX-RCT
• Status: Recruiting
• Phase: Phase 2
• Start date: January 25, 2019
• Est. completion date: April 4, 2021

Study information

• Verified date: July 2020
• Source: Hanyang University Seoul Hospital
• Contact: Ji-eun Kim
• Phone: 82-2-2290-8422
• Email: eva.jieun.kim[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: April 4, 2021
• Est. primary completion date: April 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcoholism
• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• 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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Hanyang USH	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanyang University Seoul Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	K-MADRS	Korean-Version of the Montgomery-Asberg Depression Rating Scale	From baseline for 8 weeks
Secondary	OCDS-K	Korean version of the Obsessive Compulsive Drinking Scale	from baseline for 8 weeks