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

NCT02969876 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 2016P001243
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depressive Disorder; Major Depression; Depression; Depression, Unipolar

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Secondary Outcomes (2)

• Digital Symbol Substitution Test

  6 weeks

• Rey Auditory Verbal Learning Test

  6 weeks

Study Arms (1)

Study Phase

OTHER

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.

Drug: Vortioxetine

Interventions

Vortioxetine DRUG

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

Also known as: Trintellix, Brintellix

Study Phase

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Takeda: collaborator

Study Sites (1)

the Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Depressive Disorder; Depressive Disorder, Major; Depression

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Andrew Nierenberg
• Organization: Massachusetts General Hospital

anierenberg@mgh.harvard.edu

6175122641

Study Officials

• Andrew Nierenberg, M.D.

  Depression Clinical and Research Program/ Bipolar Clinical and Research Program

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Bipolar Clinic and Research Program; Associate Director, Depression Clinical and Research Program; Director, Clinical Research Support Office, Clinical Research Program

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: November 21, 2016
• Study Start: August 24, 2017
• Primary Completion: August 6, 2018
• Study Completion: August 6, 2018
• Last Updated: October 14, 2019
• Results First Posted: October 14, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)