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Vortioxetine add-on Treatment Improves the Symptoms in Patients With Bipolar Depression (ViBiD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03598868
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : August 10, 2018
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Yong Min Ahn, Seoul National University Hospital

Brief Summary:
The purpose of this study is to validate the efficacy of Vortioxetine augmentation in bipolar disorder patients with depressive symptoms.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Depression Drug: Vortioxetine Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vortioxetine add-on Treatment Improves the Symptoms in Patients With Bipolar Depression
Actual Study Start Date : August 8, 2018
Estimated Primary Completion Date : September 25, 2021
Estimated Study Completion Date : September 25, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Experimental: Vortioxetine
Vortioxetine 5-20 mg
Drug: Vortioxetine
Augmentation : Vortioxetine 10 mg p.o. for week 1, Vortioxetine 5-20 mg p.o. for week 2,4,6.
Other Name: Brintellix®

Placebo Comparator: Placebo
Placebo augmentation
Drug: Placebo
Augmentation : Placebo for week 1,2,4,6




Primary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 6 weeks ]
    change of Montgomery-Asberg Depression Rating Scale (MADRS)


Secondary Outcome Measures :
  1. Clinical Global Impressions (CGI) scale [ Time Frame: 6 weeks ]
    change of Clinical Global Impressions (CGI) scale

  2. Digit Symbol Substitution Test (DSST) [ Time Frame: 6 weeks ]
    change of Digit Symbol Substitution Test (DSST)

  3. Medication diary [ Time Frame: 6 weeks ]
    compliance assessment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03598868


Contacts
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Contact: Sang Jin Rhee, MD 82 2 2072 2457 hellojr1123@hanmail.net

Locations
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Korea, Republic of
Inha University Hospital Not yet recruiting
Incheon, Korea, Republic of
Contact: Hyeyoung Kim, MD         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Yong Min Ahn, MD. PHD         
Sponsors and Collaborators
Seoul National University Hospital
H. Lundbeck A/S
Investigators
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Principal Investigator: Yong Min Ahn, MD, PHD Seoul National University Hospital
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Responsible Party: Yong Min Ahn, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03598868    
Other Study ID Numbers: AYM-ViBiD
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Yong Min Ahn, Seoul National University Hospital:
Bipolar Disorder
Depression, Bipolar
vortioxetine
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Vortioxetine
Antidepressive Agents
Psychotropic Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists