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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04498897
Other study ID # VTX-RCT
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
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