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

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

Study Overview

• Status: Terminated
• Conditions: Depressive Disorder; Depression; Major Depression; Depression, Unipolar
• Intervention / Treatment: Drug: Vortioxetine

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • The Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.	Drug: Vortioxetine; Vortioxetine is a selective serotonin re-uptake inhibitor (SSRI), a common form of treatment for major depressive disorder.; Other Names: Brintellix; Trintellix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks
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	6 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Takeda
• Investigators: Principal Investigator: Andrew Nierenberg, M.D., Depression Clinical and Research Program/ Bipolar Clinical and Research Program

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 24, 2017
• Primary Completion (ACTUAL): August 6, 2018
• Study Completion (ACTUAL): August 6, 2018

Study Registration Dates

• First Submitted: November 18, 2016
• First Submitted That Met QC Criteria: November 18, 2016
• First Posted (ESTIMATE): November 21, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2019
• Last Update Submitted That Met QC Criteria: September 23, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin Antagonists; Anti-Anxiety Agents; Serotonin 5-HT3 Receptor Antagonists; Vortioxetine
• Other Study ID Numbers: 2016P001243

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No