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Site was unable to reach Sponsor recruitment goals.
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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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The study is a 6-week, proof-of-concept, open trial of vortioxetine for 20 patients with major depressive disorder.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Phase | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vortioxetine | Drug | Vortioxetine is a selective serotonin re-uptake inhibitor (SSRI), a common form of treatment for major depressive disorder. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Rey Auditory Verbal Learning Test |
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Inclusion Criteria:
Exclusion Criteria:
Meets Diagnostic and Statistical Manual of Mental Disorders (versions 4 and 5) criteria for schizophrenia, schizoaffective disorder, obsessive compulsive disorder.
Unable to follow instructions or otherwise unable to participate in the trial.
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)
Patients who, in the investigator's judgment, pose a current, serious suicidal or homicidal risk.
Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease.
History of seizure disorder.
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.
History of multiple adverse drug reactions or allergy to the study drugs.
Patients with mood congruent or mood incongruent psychotic features
Current use of other psychotropic drugs.
Clinical or laboratory evidence of hypothyroidism.
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)
Patients who have had electroconvulsive therapy within the 6 months preceding baseline.
Concomitant use of serotonergic agents
Meets Diagnostic and Statistical Manual of Mental Disorders (versions 4 and 5) criteria for bipolar disorder
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Nierenberg, M.D. | Depression Clinical and Research Program/ Bipolar Clinical and Research Program | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Trial Vortioxetine | All enrolled participants received open trial of Vortioxetine for 6 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Trial Vortioxetine | All enrolled participants received open trial of Vortioxetine for 6 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tripped, hit knee, went to ER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Nierenberg | Massachusetts General Hospital | 6175122641 | anierenberg@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 2, 2018 | Sep 19, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000078784 | Vortioxetine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 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. | Posted | Mean | Standard Deviation | number of substitutions | 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 | Posted | Mean | Standard Deviation | number of words recalled | 6 weeks |
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| 0 |
| 2 |
| 0 |
| 2 |
| 1 |
| 2 |
| Migraines | General disorders | Systematic Assessment |
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| Headaches | General disorders | Systematic Assessment |
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