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

• Status: Terminated
• Trial end date: 2018-08-06
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: Takeda
• Treatments: Vortioxetine

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