Vortioxetine add-on Treatment Improves the Symptoms in Pa... | NCT03598868

Studies
Vortioxetine add-on Treatment Improves the Symptoms in Patients With Bipolar Depression

NCT03598868

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Aug 10, 2018Actual

Enrollment

100Estimated

Phase

Phase 2

Conditions

Bipolar Disorder Depression

Interventions

Vortioxetine
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 8, 2018Actual

Primary Completion Date

Sep 25, 2021Estimated

Completion Date

Sep 25, 2021Estimated

First Submitted Date

Jul 16, 2018

First Submission Date that Met QC Criteria

Jul 16, 2018

First Posted Date

Jul 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2018

Last Update Posted Date

Aug 10, 2018Actual

Name	Class
H. Lundbeck A/S	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vortioxetine	Experimental	Vortioxetine 5-20 mg	Drug: Vortioxetine
Placebo	Placebo Comparator	Placebo augmentation	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vortioxetine	Drug	Augmentation : Vortioxetine 10 mg p.o. for week 1, Vortioxetine 5-20 mg p.o. for week 2,4,6.	Vortioxetine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Montgomery-Asberg Depression Rating Scale (MADRS)	change of Montgomery-Asberg Depression Rating Scale (MADRS)	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Clinical Global Impressions (CGI) scale	change of Clinical Global Impressions (CGI) scale	6 weeks
Digit Symbol Substitution Test (DSST)	change of Digit Symbol Substitution Test (DSST)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sang Jin Rhee, MD	Contact	82 2 2072 2457		hellojr1123@hanmail.net

Overall Officials

Name	Affiliation	Role
Yong Min Ahn, MD, PHD	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Inha University Hospital	Not yet recruiting	Incheon			South Korea

ID	Term
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders
D001523	Mental Disorders

ID	Term
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds