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

Phase 4

Terminated

• Conditions: Depressive Disorder; Major Depression; Depression; Depression, Unipolar
• Interventions: Drug: Vortioxetine

• Registration Number: NCT02969876
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2016-11-18
• Study First Submitted QC: 2016-11-18
• Study First Posted: 2016-11-21
• Study Start: 2017-08-24
• Primary Completion: 2018-08-06
• Study Completion: 2018-08-06
• Status Verified: 2019-09
• Results First Submitted: 2019-09-23
• Results First Submitted QC: 2019-09-23
• Last Update Submitted: 2019-09-23
• Results First Posted: 2019-10-14
• Last Update Posted: 2019-10-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Phase	Vortioxetine	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.

Primary Outcome Measures

Name	Time	Method
Quick Inventory of Depressive Symptomatology - Clinician Version (QIDS-C)	6 weeks	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

Name	Time	Method
Digital Symbol Substitution Test	6 weeks	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	6 weeks	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

Trial Locations

Locations (1)

the Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States