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

NCT ID: NCT02969876

Last Updated: 2019-10-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-24
• Study Completion Date: 2018-08-06

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.

Conditions

Depressive Disorder; Major Depression; Depression; Depression, Unipolar

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Study Phase

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.

Group Type: OTHER

Vortioxetine

Intervention Type: DRUG

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

Interventions

Vortioxetine

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

Intervention Type: DRUG

Other Intervention Names

Trintellix; Brintellix

Eligibility Criteria

Inclusion Criteria

1. Meets Diagnostic and Statistical Manual of Mental Disorders (Versions 4 and 5) criteria for and Major Depressive Disorder.

2. Hamilton Depression Rating Scale-17 score greater than 18.

3. Men and women between ages >=18 and 65.

Exclusion Criteria

1. Meets Diagnostic and Statistical Manual of Mental Disorders (versions 4 and 5) criteria for schizophrenia, schizoaffective disorder, obsessive compulsive disorder.

2. Unable to follow instructions or otherwise unable to participate in the trial.

3. 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)

4. Patients who, in the investigator's judgment, pose a current, serious suicidal or homicidal risk.

5. Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease.

6. History of seizure disorder.

7. 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.

8. History of multiple adverse drug reactions or allergy to the study drugs.

9. Patients with mood congruent or mood incongruent psychotic features

10. Current use of other psychotropic drugs.

11. Clinical or laboratory evidence of hypothyroidism.

12. 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)

13. Patients who have had electroconvulsive therapy within the 6 months preceding baseline.

14. Concomitant use of serotonergic agents

15. Meets Diagnostic and Statistical Manual of Mental Disorders (versions 4 and 5) criteria for bipolar disorder

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Andrew A. Nierenberg, MD

Director, Bipolar Clinic and Research Program; Associate Director, Depression Clinical and Research Program; Director, Clinical Research Support Office, Clinical Research Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew Nierenberg, M.D.

Role: PRINCIPAL_INVESTIGATOR

Depression Clinical and Research Program/ Bipolar Clinical and Research Program

Locations

the Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2016P001243

Identifier Type: -

Identifier Source: org_study_id