Vortioxetine for Treatment of Depressive Mood and Alcohol Use

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

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.

Study Overview

• Status: Unknown
• Conditions: Alcoholism; Depressive Disorder, Major
• Intervention / Treatment: Drug: Vortioxetine; Drug: Acamprosate

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

• Study Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ji-eun Kim; Phone Number: 82-2-2290-8422; Email: eva.jieun.kim@gmail.com
• Study Contact Backup: Name: Sungwon Roh; Phone Number: 82-2-2290-8422; Email: swroh@hanyang.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Hanyang USH
    • Contact: Roh Sungwon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Test group; Vortioxetine + Acamprosate	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; 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
Placebo Comparator: Placebo Group; Placebo + Acamprosate	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hanyang University Seoul Hospital
• Investigators: Principal Investigator: Sungwon Roh, swroh@hanyang.ac.kr

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2019
• Primary Completion (Anticipated): April 4, 2021
• Study Completion (Anticipated): April 4, 2021

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: July 30, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: July 30, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Mood Disorders; Alcohol Drinking; Alcoholism; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin Antagonists; Anti-Anxiety Agents; Serotonin 5-HT3 Receptor Antagonists; Alcohol Deterrents; Vortioxetine; Acamprosate
• Other Study ID Numbers: VTX-RCT

Drug and device information, study documents

• 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