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

Depression Clinical Trial

— VOR-IISR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02969876
• Other study ID #: 2016P001243
• Status: Terminated
• Phase: Phase 4
• Start date: August 24, 2017
• Est. completion date: August 6, 2018

Study information

• Verified date: September 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 6, 2018
• Est. primary completion date: August 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Unipolar
• Depressive Disorder
• Major Depression

Intervention

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

Locations

Country	Name	City	State
United States	the Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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