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Pattern Separation, Brain Derived Neurotrophic Factors, and Mechanisms of Vortioxetine (VOR-IISR)

Primary Purpose

Depressive Disorder, Major Depression, Depression

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Vortioxetine

About this trial

This is an interventional basic science trial for Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Meets Diagnostic and Statistical Manual of Mental Disorders (Versions 4 and 5) criteria for and Major Depressive Disorder.
Hamilton Depression Rating Scale-17 score greater than 18.
Men and women between ages >=18 and 65.

Exclusion Criteria:

Meets Diagnostic and Statistical Manual of Mental Disorders (versions 4 and 5) criteria for schizophrenia, schizoaffective disorder, obsessive compulsive disorder.
Unable to follow instructions or otherwise unable to participate in the trial.
Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, partner with vasectomy)
Patients who, in the investigator's judgment, pose a current, serious suicidal or homicidal risk.
Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease.
History of seizure disorder.
The following Diagnostic and Statistical Manual of Mental Disorders (Version 4) diagnoses (any current or past history, except substance abuse disorders):
Organic mental disorders, schizoaffective disorder, delusional disorder, psychotic disorders not elsewhere classified.
History of multiple adverse drug reactions or allergy to the study drugs.
Patients with mood congruent or mood incongruent psychotic features
Current use of other psychotropic drugs.
Clinical or laboratory evidence of hypothyroidism.
Patients who have failed to respond during the course of their current major depressive episode to at least one adequate antidepressant trial, defined as six weeks or more of treatment with citalopram 40 mg/day (or its antidepressant equivalent)
Patients who have had electroconvulsive therapy within the 6 months preceding baseline.
Concomitant use of serotonergic agents
Meets Diagnostic and Statistical Manual of Mental Disorders (versions 4 and 5) criteria for bipolar disorder

Sites / Locations

the Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Study Phase

Arm Description

During this phase participants receive open label vortioxetine for 6 weeks. Participants come to the Depression Clinical & Research Program at the Massachusetts General Hospital for visits once a week. During these visits the participants meet with clinicians and complete cognitive tasks.

Outcomes

Primary Outcome Measures

Quick Inventory of Depressive Symptomatology - Clinician Version (QIDS-C)

This scale is designed to assess the severity of depressive symptoms. The minimum score is a 0 (zero) and the maximum score is a 27, and a higher score means a worse outcome.

Secondary Outcome Measures

Digital Symbol Substitution Test

A cognitive measure sensitive to learning and memory. Participants are given 90 seconds to match as many symbols to numbers according to a key located on the top of the page. A higher score means a better outcome.

Rey Auditory Verbal Learning Test

A cognitive measure sensitive to learning and memory. Minimum score is a zero. Maximum score is a 75. A higher score means a better outcome

Full Information

NCT ID

NCT02969876

First Posted

November 18, 2016

Last Updated

September 23, 2019

Sponsor

Massachusetts General Hospital

Collaborators

Takeda

1. Study Identification

Unique Protocol Identification Number

NCT02969876

Brief Title

Pattern Separation, Brain Derived Neurotrophic Factors, and Mechanisms of Vortioxetine

Acronym

VOR-IISR

Official Title

Pattern Separation, Brain Derived Neurotrophic Factors, and Mechanisms of Vortioxetine

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Terminated

Why Stopped

Site was unable to reach Sponsor recruitment goals.

Study Start Date

August 24, 2017 (Actual)

Primary Completion Date

August 6, 2018 (Actual)

Study Completion Date

August 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

Takeda

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The study is a 6-week, proof-of-concept, open trial of vortioxetine for 20 patients with major depressive disorder.

Detailed Description

The U.S. Food and Drug Administration approved vortioxetine to treat major depressive disorder in 2013. Researchers believe vortioxetine may improve pattern separation and pattern completion (i.e., a neurological function) in people with major depressive disorder; thus, this research study aims to determine how vortioxetine increases a person's ability to think. The current study is an open label trial, therefore, all participants will receive vortioxetine. Furthermore, participants receive the vortioxetine at no cost. It will take participants 6 weeks to complete this study. Participants are asked to come to the Mass General Hospital campus for 1 screening visit which includes a full psychiatric evaluation, and 5 additional study visits. During study visits, participants will meet with a clinician and then complete computer based cognitive tests.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depressive Disorder, Major Depression, Depression, Depression, Unipolar

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study Phase

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

Vortioxetine

Other Intervention Name(s)

Trintellix, Brintellix

Intervention Description

Vortioxetine is a selective serotonin re-uptake inhibitor (SSRI), a common form of treatment for major depressive disorder.

Primary Outcome Measure Information:

Title

Quick Inventory of Depressive Symptomatology - Clinician Version (QIDS-C)

Description

This scale is designed to assess the severity of depressive symptoms. The minimum score is a 0 (zero) and the maximum score is a 27, and a higher score means a worse outcome.

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Digital Symbol Substitution Test

Description

Time Frame

6 weeks

Title

Rey Auditory Verbal Learning Test

Description

A cognitive measure sensitive to learning and memory. Minimum score is a zero. Maximum score is a 75. A higher score means a better outcome

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Meets Diagnostic and Statistical Manual of Mental Disorders (Versions 4 and 5) criteria for and Major Depressive Disorder. Hamilton Depression Rating Scale-17 score greater than 18. Men and women between ages >=18 and 65. Exclusion Criteria: Meets Diagnostic and Statistical Manual of Mental Disorders (versions 4 and 5) criteria for schizophrenia, schizoaffective disorder, obsessive compulsive disorder. Unable to follow instructions or otherwise unable to participate in the trial. Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, partner with vasectomy) Patients who, in the investigator's judgment, pose a current, serious suicidal or homicidal risk. Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease. History of seizure disorder. The following Diagnostic and Statistical Manual of Mental Disorders (Version 4) diagnoses (any current or past history, except substance abuse disorders): Organic mental disorders, schizoaffective disorder, delusional disorder, psychotic disorders not elsewhere classified. History of multiple adverse drug reactions or allergy to the study drugs. Patients with mood congruent or mood incongruent psychotic features Current use of other psychotropic drugs. Clinical or laboratory evidence of hypothyroidism. Patients who have failed to respond during the course of their current major depressive episode to at least one adequate antidepressant trial, defined as six weeks or more of treatment with citalopram 40 mg/day (or its antidepressant equivalent) Patients who have had electroconvulsive therapy within the 6 months preceding baseline. Concomitant use of serotonergic agents Meets Diagnostic and Statistical Manual of Mental Disorders (versions 4 and 5) criteria for bipolar disorder

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew Nierenberg, M.D.

Organizational Affiliation

Depression Clinical and Research Program/ Bipolar Clinical and Research Program

Official's Role

Principal Investigator

Facility Information:

Facility Name

the Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Pattern Separation, Brain Derived Neurotrophic Factors, and Mechanisms of Vortioxetine

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