Depression, Depression, Unipolar, Depressive Disorder, Major Depression
Conditions
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.
Interventions
DRUGVortioxetine
Vortioxetine is a selective serotonin re-uptake inhibitor (SSRI), a common form of treatment for major depressive disorder.
Sponsors
Takeda
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Phase 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.
Vortioxetine: Vortioxetine is a selective serotonin re-uptake inhibitor (SSRI), a common form of treatment for major depressive disorder. | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Study Phase |
|---|---|
| Age, Continuous | 20.5 years STANDARD_DEVIATION 3.54 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 1 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Phase | Quick Inventory of Depressive Symptomatology - Clinician Version (QIDS-C) | 12.5 score on a scale | Standard Deviation 10.6 |
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Phase | Digital Symbol Substitution Test | 41.5 number of substitutions | Standard Deviation 1.5 |
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
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Phase | Rey Auditory Verbal Learning Test | 54 number of words recalled | Standard Deviation 1 |