Depressive Disorder, MajorPhase 2NCT04498897
Vortioxetine for Treatment of Depressive Mood and Alcohol Use
A Phase 2 study testing Vortioxetine and Acamprosate in people with Depressive Disorder, Major and Alcoholism, run by Hanyang University Seoul Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Depressive Disorder, Major, Alcoholism
- What is being tested?
- Vortioxetine and Acamprosate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Jan 2019to 4 Apr 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Depressive Disorder, Major, Alcoholism
- Being tested
- Vortioxetine, Acamprosate
- Medical subject headings
- Depressive Disorder, Major, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VortioxetineDrug
- Baseline: Vortioxetine 10mg (or placebo) + Acamprosate
- First 2 weeks: Vortioxetine 5-10mg (or placebo) + Acamprosate
- Last 6 weeks: Vortioxetine 5-20mg (or placebo) + Acamprosate
AcamprosateDrug
- Baseline: Vortioxetine 10mg (or placebo) + Acamprosate
- First 2 weeks: Vortioxetine 5-10mg (or placebo) + Acamprosate
- Last 6 weeks: Vortioxetine 5-20mg (or placebo) + Acamprosate
| Study group | Role | What they receive |
|---|---|---|
| Test group | Active comparator | Vortioxetine + Acamprosate Receives: Drug: Vortioxetine; Drug: Acamprosate |
| Placebo Group | Placebo comparator | Placebo + Acamprosate Receives: Drug: Acamprosate |
What is being measured
The primary outcome is the main question the study is designed to answer.
K-MADRS
Korean-Version of the Montgomery-Asberg Depression Rating Scale
Measured: From baseline for 8 weeks
Secondary outcomes (1)
OCDS-K
Korean version of the Obsessive Compulsive Drinking Scale
Measured: from baseline for 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start25 Jan 2019
- Primary completion4 Apr 2021 (estimated)
- Study completion4 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, placebo-controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanyang University Seoul Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sungwon Roh, Hanyang University Seoul Hospital
- Investigators
- Sungwon Roh, Principal investigator, swroh@hanyang.ac.kr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498897
- Sponsor's protocol ID
- VTX-RCT
- Status last verified
- Jul 2020
- First submitted
- 30 Jul 2020
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04498897
- Acronym / sponsor ID
- VTX-RCT
- Conditions
- Depressive Disorder, Major, Alcoholism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Hanyang University Seoul HospitalUniversity, hospital or other
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 4 Apr 2021 (estimated)
- Study completion
- 4 Apr 2021 (estimated)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Test group | Active comparator | Drug: Vortioxetine, Drug: AcamprosateVortioxetine + Acamprosate |
| Placebo Group | Placebo comparator | Drug: AcamprosatePlacebo + Acamprosate |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Test group |
| 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 | Drug | Placebo Group, Test group |
Primary outcome
K-MADRS
Time frame: From baseline for 8 weeks
Korean-Version of the Montgomery-Asberg Depression Rating Scale
1 secondary outcome
OCDS-K
Time frame: from baseline for 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sungwon Roh principal investigator
swroh@hanyang.ac.kr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vortioxetine and Acamprosate in people with Depressive Disorder, Major and Alcoholism, run by Hanyang University Seoul Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ji-eun Kim (82-2-2290-8422, eva.jieun.kim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
K-MADRS (time frame: From baseline for 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2020.