Pattern Separation, Brain Derived Neurotrophic Factors, and Mechanisms of Vortioxetine
Condition: Depressive Disorder; Major Depression; Depression; Depression, Unipolar
MeSH terms: Depression; Depressive Disorder
Intervention: Vortioxetine
Intervention description: Vortioxetine is a selective serotonin re-uptake inhibitor (SSRI), a common form of treatment for major depressive disorder.
Intervention MeSH terms: Vortioxetine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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

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