Bipolar Disorder DepressionPhase 2ViBiDNCT03598868
Vortioxetine add-on Treatment Improves the Symptoms in Patients With Bipolar Depression
A Phase 2 study testing Vortioxetine in people with Bipolar Disorder Depression, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
The purpose of this study is to validate the efficacy of Vortioxetine augmentation in bipolar disorder patients with depressive symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder Depression
- What is being tested?
- Vortioxetine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 8 Aug 2018to 25 Sep 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with Bipolar I Disorder, Bipolar II Disorder, Other Specified Bipolar and Related Disorder, Unspecified Bipolar and Related Disorder by Diagnostic and Statistical Manual (DSM)-V criteria.
- 18 to 65 years of age
- Patients with Montgomery-Åsberg Depression Rating Scale score ≥ 23 (moderate to severe depression), after 4 weeks or more of treatment by main medication of mood stabilizer or antipsychotics
- Patients with Young Mania Rating Scale score lower than 10, after 4 weeks or more of treatment by main medication of mood stabilizer or antipsychotics
Who cannot join
- Currently experiencing manic, hypomanic, or mixed episode
- Comorbid with serious medical illness
- Comorbid with substance use disorder, medical illness or other neurologic disorder that may have caused depressive symptoms other than by bipolar disorder
- Pregnancy or Breastfeeding women
- Those who are hypersensitive to the main or other ingredient of the medication
- Currently on Monoamine oxidase (MAO) inhibitor or those who have discontinued MAO inhibitor in the last 14 days
- Severe liver disease, severe renal disease
- Bleeding tendency/disorder
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Not yet recruiting
Inha University Hospital
Incheon
Hyeyoung Kim, MD
- Recruiting
Seoul National University Hospital
Seoul
Yong Min Ahn, MD. PHD
About this study
The purpose of this study is to validate the efficacy of Vortioxetine augmentation in bipolar disorder patients with depressive symptoms.
Read the detailed description
In this study, the investigators are going to examine the efficacy of vortioxetine augmentation in bipolar disorder patients with depressive symptoms.
The study design is a double-blinded 6-week prospective study. It would be useful for clinicians because it will provide new evidence for the effect of vortioxetine in bipolar disorder patients with depressive symptoms.
- Conditions
- Bipolar Disorder Depression
- Being tested
- Vortioxetine, Placebo
- Keywords
- Bipolar Disorder, Depression, Bipolar, vortioxetine
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VortioxetineDrug
Also called Brintellix®
Augmentation : Vortioxetine 10 mg p.o. for week 1, Vortioxetine 5-20 mg p.o. for week 2,4,6.
PlaceboDrug
Augmentation : Placebo for week 1,2,4,6
| Study group | Role | What they receive |
|---|---|---|
| Vortioxetine | Experimental | Vortioxetine 5-20 mg Receives: Drug: Vortioxetine |
| Placebo | Placebo comparator | Placebo augmentation Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale (MADRS)
change of Montgomery-Asberg Depression Rating Scale (MADRS)
Measured: 6 weeks
Secondary outcomes (3)
Clinical Global Impressions (CGI) scale
change of Clinical Global Impressions (CGI) scale
Measured: 6 weeks
Digit Symbol Substitution Test (DSST)
change of Digit Symbol Substitution Test (DSST)
Measured: 6 weeks
Medication diary
compliance assessment
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start8 Aug 2018
- Primary completion25 Sep 2021 (estimated)
- Study completion25 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Disorder DepressionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- H. Lundbeck A/S
- Responsible party
- Principal investigator, Yong Min Ahn, Seoul National University Hospital
- Investigators
- Yong Min Ahn, MD, PHD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598868
- Sponsor's protocol ID
- AYM-ViBiD
- Acronym
- ViBiD
- Status last verified
- Aug 2018
- First submitted
- 16 Jul 2018
- Last updated
- 10 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vortioxetine add-on Treatment Improves the Symptoms in Patients With Bipolar Depression
- ClinicalTrials.gov ID
- NCT03598868
- Acronym / sponsor ID
- ViBiD / AYM-ViBiD
- Conditions
- Bipolar Disorder Depression
- Keywords
- Bipolar Disorder, Depression, Bipolar, vortioxetine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- H. Lundbeck A/S
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 25 Sep 2021 (estimated)
- Study completion
- 25 Sep 2021 (estimated)
- First posted
- 26 Jul 2018 (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.
The purpose of this study is to validate the efficacy of Vortioxetine augmentation in bipolar disorder patients with depressive symptoms.
Detailed description
In this study, the investigators are going to examine the efficacy of vortioxetine augmentation in bipolar disorder patients with depressive symptoms.
The study design is a double-blinded 6-week prospective study. It would be useful for clinicians because it will provide new evidence for the effect of vortioxetine in bipolar disorder patients with depressive symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vortioxetine | Experimental | Drug: VortioxetineVortioxetine 5-20 mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo augmentation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with Bipolar I Disorder, Bipolar II Disorder, Other Specified Bipolar and Related Disorder, Unspecified Bipolar and Related Disorder by Diagnostic and Statistical Manual (DSM)-V criteria.
- 18 to 65 years of age
- Patients with Montgomery-Åsberg Depression Rating Scale score ≥ 23 (moderate to severe depression), after 4 weeks or more of treatment by main medication of mood stabilizer or antipsychotics
- Patients with Young Mania Rating Scale score lower than 10, after 4 weeks or more of treatment by main medication of mood stabilizer or antipsychotics
Key exclusion criteria (8 listed)
- Currently experiencing manic, hypomanic, or mixed episode
- Comorbid with serious medical illness
- Comorbid with substance use disorder, medical illness or other neurologic disorder that may have caused depressive symptoms other than by bipolar disorder
- Pregnancy or Breastfeeding women
- Those who are hypersensitive to the main or other ingredient of the medication
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 |
|---|---|---|
| VortioxetineAlso: Brintellix®Augmentation : Vortioxetine 10 mg p.o. for week 1, Vortioxetine 5-20 mg p.o. for week 2,4,6. | Drug | Vortioxetine |
| PlaceboAugmentation : Placebo for week 1,2,4,6 | Drug | Placebo |
Primary outcome
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 6 weeks
change of Montgomery-Asberg Depression Rating Scale (MADRS)
3 secondary outcomes
Clinical Global Impressions (CGI) scale
Time frame: 6 weeks
Digit Symbol Substitution Test (DSST)
Time frame: 6 weeks
Medication diary
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
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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.
Yong Min Ahn, MD, PHD principal investigator
Seoul National University Hospital
2 sites 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 in people with Bipolar Disorder Depression, run by Seoul National University Hospital at 2 sites 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 8 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 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Sang Jin Rhee, MD (82 2 2072 2457, hellojr1123@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: 6 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 10 Aug 2018.