Clinical trial NCT02969876: Pattern Separation, Brain Derived Neurotrophic Factors, and Mechanisms of Vortioxetine
Official title: Pattern Separation, Brain Derived Neurotrophic Factors, and Mechanisms of Vortioxetine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Depressive Disorder
Major Depression
Depression
Depression, Unipolar
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Takeda
First posted: 2016-11-21
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Quick Inventory of Depressive Symptomatology - Clinician Version (QIDS-C)
timeFrame: 6 weeks
Secondary outcomes:
measure: Digital Symbol Substitution Test
timeFrame: 6 weeks
measure: Rey Auditory Verbal Learning Test
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: the Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Depression Clinical and Research Program/ Bipolar Clinical and Research Program
name: Andrew Nierenberg, M.D.
role: PRINCIPAL_INVESTIGATOR
References: