Major Depressive DisorderPhase 4NCT02749721

The Relationship Among Changes in Brain Network Activation in Adult Outpatients With Major Depressive Disorder

A Phase 4 study testing vortioxetine in people with Major Depressive Disorder, run by Rush University Medical Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to explore patterns of Brain Network Activation (BNA) changes from baseline to endpoint on 1) efficacy of core symptoms of Major Depressive Disorder (MDD) and 2) improvement of cognitive dysfunction with acute treatment with flexible dose vortioxetine in adult outpatients with MDD and… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: vortioxetine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 2 sitesUnited States
Study dates: Dec 2016to 31 Jan 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The subject has single episode or recurrent MDD (acute onset of recurrence of recurrent MDD with poor inter-episode recovery) (inter-episode periods cannot meet full MDD criteria) as the primary diagnosis according to DSM-IV-TR criteria. The current major depressive episode (MDE) will be confirmed using the Mini International Neuropsychiatric Interview (MINI V6.0.0).
The subject has a MADRS total score ≥26.
Subject reports subjective cognitive dysfunction (such as difficulty concentrating, slow thinking, and difficulty in learning new things or remembering things).
The reported duration of the current MDE is at least 3 months and no longer than 24 months.
The subject is a man or woman between 18 and 65 years old, inclusive.
Right-handed, normal (corrected) vision, and normal hearing.

Who cannot join

The subject has a score of ≥70 on the Digit Symbol Substitution Test (DSST) at the Baseline Visit.
Failure to respond to or inability to tolerate an adequate trial of vortioxetine in the past.
Exposure to an investigational compound 30 days prior to enrollment
Exposure to any psychoactive or otherwise excluded medication within five half-lives of the baseline visit or during the study. Excluded medications include: antidepressants, anxiolytics, anticonvulsants, barbiturates, chloral hydrate, lithium, antipsychotics, benzodiazepines, hypnotics, monoamine oxidase inhibitors (MAOIs), muscle relaxers, triptans, centrally-acting antihistamines, central alpha-2 agonists, decongestants, psychostimulants, dopamine agonists, opioid pain medications, oral corticosteroids, L-methylfolate, S-adenosyl methionine (SAMe), 5-HTP (hydroxytryptophan), St. John's Wort,
The subject has 1 or more of the following:
Primary psychiatric disorder other than MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders 4 Text Revision (DSM-IV-TR) (as assessed by the MINI, Version 6.0.0).

Show all 21Show fewer

Current or history of attention deficit hyperactivity disorder (ADHD), pervasive developmental disorder, manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
Current diagnosis of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as defined in the DSM-IV-TR that has not been in sustained full remission for at least 6 months (for abuse) and 12 months (for dependence) prior to Screening.
Positive urine drug screen prior to Baseline.
Presence or history of a clinically significant neurological disorder (including epilepsy).
Neurodegenerative disorder (Alzheimer Disease, Parkinson Disease, multiple sclerosis, Huntington Disease, etc).
Any unstable medical condition as determined by the principal investigator (PI).
Any DSM-IV Axis II disorder that might compromise the study as determined by the PI.
The subject has any other disorder for which the treatment takes priority over treatment of MDD or is likely to interfere with study treatment or impair treatment compliance.
The subject has physical, cognitive, or language impairment of such severity as to adversely affect the validity of the data derived from the neuropsychological tests.
The subject has a significant risk of suicide according to the PI's clinical judgment.
The subject, in the opinion of the PI, poses a risk of harm to others.
The subject has initiated formal cognitive or behavioral therapy, systemic psychotherapy within less than 6 months of study screening, or has plans to initiate such therapy during the study.
The subject has received electroconvulsive therapy, vagus nerve stimulation, or repetitive transcranial magnetic stimulation within 12 months prior to Screening.
The current MDE is considered by the PI to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each at the recommended dose.
The subject is pregnant or breastfeeding, or is intending to become pregnant before, during, or within 30 days after participating in this study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Rush University Medical Center
Chicago, Illinois, 60612
Rush University Medical Center
Skokie, Illinois, 60076

Other trials in United States

About this study

Official title: Relationship Among Changes in Brain Network Activation, Changes in Core Depressive and Cognitive Symptoms and Safety and Tolerability in Adults With Major Depressive Disorder Treated With Open-Label, Flexible-Dose Vortioxetine

Read the detailed description

Vortioxetine is a novel antidepressant with hypothetical multimodal mechanism of action. It is thought to work through a combination of multiple pharmacological modes of action: 5-HT (hydroxytryptamine, or serotonin) reuptake inhibition, 5-HT3 (hydroxytryptamine, or serotonin) and 5-HT7 (hydroxytryptamine, or serotonin) receptor antagonism, 5-HT1A (hydroxytryptamine, or serotonin) receptor agonism, and 5-HT1B (hydroxytryptamine, or serotonin) receptor partial agonism. In vivo nonclinical studies have demonstrated that vortioxetine enhances levels of the neurotransmitters 5-HT (hydroxytryptamine, or serotonin), norepinephrine (NE), dopamine (DA), acetylcholine and histamine in specific areas of the brain. These affinities are all considered to be of clinical relevance and involved in the mechanism of action at therapeutic doses.

Vortioxetine has been shown to improve core depressive symptoms and improve cognitive function in adult outpatients with MDD and subjective complaints of cognitive function. This pilot study is intended to evaluate the extent to which BNA technology can provide clinically valuable information and provide information toward designing a subsequent confirmatory study that will further elucidate the effect of vortioxetine on MDD and cognitive function in this population. This exploratory study will ascertain the acute changes in core depression symptoms, cognitive function, tolerability, and safety using flexible-dose vortioxetine in adult outpatients with MDD with subjective complaints of cognitive functioning, as measured by BNA changes and standard outcome measures for depression and cognition.

The study consists of 8 weeks of open-label treatment for MDD with response to treatment measured by standard research depression scales and BNA electroencephalogram (EEG) readings taken at certain points during the trial. An important aim in this study is to explore what correlations may exist between changes in measured brainwave patterns and reported change in depressive symptoms

Conditions: Major Depressive Disorder
Being tested: vortioxetine
Keywords: depression, brain network activation, vortioxetine
Medical subject headings: Depressive Disorder, Major, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

vortioxetineDrug
Open-label vortioxetine

Study groups in NCT02749721
Study group	Role	What they receive
Other - vortioxetine	Other	Open-label vortioxetine Receives: Drug: vortioxetine

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Montgomery and Asberg Depression Rating Scale (MADRS)
The MADRS is a 10-item rating scale designed to assess the severity of symptoms of depression. Range is 0-60. Higher score means more severe.
Measured: from baseline to endpoint (up to 8 weeks)
Change From Baseline to Endpoint in Digital Symbol Substitution Test.
Change in cognitive function defined as change from baseline to endpoint. The Digital Symbol Substitution Test (DSST) is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making and motor skills. The DSST consists of 133 digits and requires the subject to substitute each digit with a simple symbol in a 90-second period. The number of correct symbols within the allowed time (eg, 90 sec) is measured. It takes approximately 5 minutes to complete and score the DSST.
Measured: Baseline to endpoint (week 8)
BNA Scores Amplitudes
Brain Network Analytics (BNA) is a tool intended for the post-hoc statistical analysis of the human EEG, utilizing both resting-state EEG and event-related potentials (ERP) waveforms. The BNA algorithm compares a patient's ERP amplitudes and latencies to those of a large group of healthy, age-matched subjects in order to visualize and quantify changes in specific brain functions. The BNA algorithm was used to detect subjects' P200 and P300 ERP components from EEG data recorded during the AOB and VGNG tasks. BNA scores represent these ERP components in terms of amplitude (in microvolts) and latency (in milliseconds).
Measured: Baseline to Endpoint (8 weeks)
BNA Scores Latencies
Brain Network Analytics (BNA) is a tool intended for the post-hoc statistical analysis of the human EEG, utilizing both resting-state EEG and event-related potentials (ERP) waveforms. The BNA algorithm compares a patient's ERP amplitudes and latencies to those of a large group of healthy, age-matched subjects in order to visualize and quantify changes in specific brain functions. The BNA algorithm was used to detect subjects' P200 and P300 ERP components from EEG data recorded during the AOB and VGNG tasks. BNA scores represent these ERP components in terms of amplitude (in microvolts) and latency (in milliseconds).
Measured: Baseline to Endpoint (8 weeks)

Secondary outcomes (6)

Changes in Hamilton Depression Rating Scale (HDRS) 17 From Baseline to 8 Week Endpoint
The HDRS is a clinician-rated used to rate the patient's depressive state. The 17 question version of the scale rates depressive state based on feelings of depression, guilt, suicidality, anxiety, agitation, somatic symptoms, level of insight, patterns of insomnia, loss of interest in work and other activities, weight loss, and hypochondriasis. Additionally, the 28 question version rates depersonalization, paranoia, obsessions/compulsions, hypersomnia, appetite increase, and psychomotor slowing. The total score is obtained by summing the score of each item, 0-4 (symptom is absent, mild, moderate, or severe) or 0-2 (absent, slight or trivial, clearly present). Scores can range from 0 to 54 for the 17 question version and 0 to 83 for the 28 question version. Scores between 0 and 6 do not indicate the presence of depression, scores between 7 and 17 indicate mild depression, scores between 18 and 24 indicate moderate depression, and scores over 24 indicate severe depression.
Measured: Baseline to endpoint (week 8)
Changes in Hamilton Depression Rating Scale (HDRS) 28 From Baseline to 8 Week Endpoint
The HDRS is a clinician-rated used to rate the patient's depressive state. The 17 question version of the scale rates depressive state based on feelings of depression, guilt, suicidality, anxiety, agitation, somatic symptoms, level of insight, patterns of insomnia, loss of interest in work and other activities, weight loss, and hypochondriasis. Additionally, the 28 question version rates depersonalization, paranoia, obsessions/compulsions, hypersomnia, appetite increase, and psychomotor slowing. The total score is obtained by summing the score of each item, 0-4 (symptom is absent, mild, moderate, or severe) or 0-2 (absent, slight or trivial, clearly present). Scores can range from 0 to 54 for the 17 question version and 0 to 83 for the 28 question version. Scores between 0 and 6 do not indicate the presence of depression, scores between 7 and 17 indicate mild depression, scores between 18 and 24 indicate moderate depression, and scores over 24 indicate severe depression.
Measured: Baseline to endpoint (week 8)
Changes in Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-16-SR) From Baseline to 8 Week Endpoint
The QIDS-16-SR is a 16-item self-rated assessment of the severity of depressive symptoms. The assessments can be used to screen for depression, although they have been used predominantly as measures of symptom severity. The nine domains comprise 1) sad mood; 2) concentration; 3) self-criticism; 4) suicidal ideation; 5) interest; 6) energy/fatigue; 7) sleep disturbance (initial, middle, and late insomnia or hypersomnia); 8) decrease or increase in appetite or weight; and 9) psychomotor agitation or retardation. The total score ranges from 0 to 27 with higher scores equating to more severe symptomatology. The seven day period prior to assessment is the usual time frame for assessing symptom severity.
Measured: Baseline to endpoint (week 8)
Changes in Clinical Global Impression Scale (CGI-S) From Baseline to 8 Week Endpoint
The CGI-S assesses the clinician's impression of the subject's current mental illness state (considering their total clinical experience with this particular population) via 7 point scale (ranging from 1-7) with higher scores equating to more symptoms. For example, a score of 1 = normal, not at all ill and a score of 7 = severely ill.
Measured: Baseline to endpoint (week 8)
Correlations Between BNA Amplitude Scores and Clinical, Cognitive, and Functionality Assessments Using Baseline Scores
Pearson correlation was used to examine the associations between baseline BNA amplitude scores and outcomes including measures of MDD symptoms, cognitive function and functionality.
Measured: Baseline to Endpoint (8 weeks)
Correlations Between BNA Latency Scores and Clinical, Cognitive, and Functionality Assessments Using Baseline Scores
Pearson correlation was used to examine the associations between baseline BNA latency scores and outcomes including measures of MDD symptoms, cognitive function and functionality.
Measured: Baseline to Endpoint (8 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 201631 Jan 2019

First posted25 Apr 2016 (estimated)
Study startDec 2016
Primary completion31 Jan 2019
Study completion31 Jan 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by Rush University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02749721
Sponsor's protocol ID: IISR-2014-100702a
Status last verified: Sep 2021
First submitted: 14 Apr 2016
Last updated: 4 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relationship Among Changes in Brain Network Activation, Changes in Core Depressive and Cognitive Symptoms and Safety and Tolerability in Adults With Major Depressive Disorder Treated With Open-Label, Flexible-Dose Vortioxetine
ClinicalTrials.gov ID: NCT02749721
Acronym / sponsor ID: IISR-2014-100702a
Conditions: Major Depressive Disorder
Keywords: depression, brain network activation, vortioxetine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Rush University Medical CenterUniversity, hospital or other
Collaborators: Takeda Pharmaceuticals North America, Inc., ElMindA Ltd
Study start: Dec 2016 (actual)
Primary completion: 31 Jan 2019 (actual)
Study completion: 31 Jan 2019 (actual)
First posted: 25 Apr 2016 (estimated)
Results: Posted 4 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Other - vortioxetine	Other	Drug: vortioxetineOpen-label vortioxetine

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

The subject has single episode or recurrent MDD (acute onset of recurrence of recurrent MDD with poor inter-episode recovery) (inter-episode periods cannot meet full MDD criteria) as the primary diagnosis according to DSM-IV-TR criteria. The current major depressive episode (MDE) will be confirmed using the Mini International Neuropsychiatric Interview (MINI V6.0.0).
The subject has a MADRS total score ≥26.
Subject reports subjective cognitive dysfunction (such as difficulty concentrating, slow thinking, and difficulty in learning new things or remembering things).
The reported duration of the current MDE is at least 3 months and no longer than 24 months.
The subject is a man or woman between 18 and 65 years old, inclusive.

Key exclusion criteria (21 listed)

The subject has a score of ≥70 on the Digit Symbol Substitution Test (DSST) at the Baseline Visit.
Failure to respond to or inability to tolerate an adequate trial of vortioxetine in the past.
Exposure to an investigational compound 30 days prior to enrollment
Exposure to any psychoactive or otherwise excluded medication within five half-lives of the baseline visit or during the study. Excluded medications include: antidepressants, anxiolytics, anticonvulsants, barbiturates, chloral hydrate, lithium, antipsychotics, benzodiazepines, hypnotics, monoamine oxidase inhibitors (MAOIs), muscle relaxers, triptans, centrally-acting antihistamines, central alpha-2 agonists, decongestants, psychostimulants, dopamine agonists, opioid pain medications, oral corticosteroids, L-methylfolate, S-adenosyl methionine (SAMe), 5-HTP (hydroxytryptophan), St. John's Wort,
The subject has 1 or more of the following:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
vortioxetineOpen-label vortioxetine	Drug	Other - vortioxetine

Primary outcome

Change in Montgomery and Asberg Depression Rating Scale (MADRS)
Time frame: from baseline to endpoint (up to 8 weeks)
The MADRS is a 10-item rating scale designed to assess the severity of symptoms of depression. Range is 0-60. Higher score means more severe.
Change From Baseline to Endpoint in Digital Symbol Substitution Test.
Time frame: Baseline to endpoint (week 8)
Change in cognitive function defined as change from baseline to endpoint. The Digital Symbol Substitution Test (DSST) is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making and motor skills. The DSST consists of 133 digits and requires the subject to substitute each digit with a simple symbol in a 90-second period. The number of correct symbols within the allowed time (eg, 90 sec) is measured. It takes approximately 5 minutes to complete and score the DSST.
BNA Scores Amplitudes
Time frame: Baseline to Endpoint (8 weeks)
Brain Network Analytics (BNA) is a tool intended for the post-hoc statistical analysis of the human EEG, utilizing both resting-state EEG and event-related potentials (ERP) waveforms. The BNA algorithm compares a patient's ERP amplitudes and latencies to those of a large group of healthy, age-matched subjects in order to visualize and quantify changes in specific brain functions. The BNA algorithm was used to detect subjects' P200 and P300 ERP components from EEG data recorded during the AOB and VGNG tasks. BNA scores represent these ERP components in terms of amplitude (in microvolts) and latency (in milliseconds).
BNA Scores Latencies
Time frame: Baseline to Endpoint (8 weeks)
Brain Network Analytics (BNA) is a tool intended for the post-hoc statistical analysis of the human EEG, utilizing both resting-state EEG and event-related potentials (ERP) waveforms. The BNA algorithm compares a patient's ERP amplitudes and latencies to those of a large group of healthy, age-matched subjects in order to visualize and quantify changes in specific brain functions. The BNA algorithm was used to detect subjects' P200 and P300 ERP components from EEG data recorded during the AOB and VGNG tasks. BNA scores represent these ERP components in terms of amplitude (in microvolts) and latency (in milliseconds).

6 secondary outcomes

Changes in Hamilton Depression Rating Scale (HDRS) 17 From Baseline to 8 Week Endpoint
Time frame: Baseline to endpoint (week 8)
Changes in Hamilton Depression Rating Scale (HDRS) 28 From Baseline to 8 Week Endpoint
Time frame: Baseline to endpoint (week 8)
Changes in Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-16-SR) From Baseline to 8 Week Endpoint
Time frame: Baseline to endpoint (week 8)
Changes in Clinical Global Impression Scale (CGI-S) From Baseline to 8 Week Endpoint
Time frame: Baseline to endpoint (week 8)
Correlations Between BNA Amplitude Scores and Clinical, Cognitive, and Functionality Assessments Using Baseline Scores
Time frame: Baseline to Endpoint (8 weeks)
Correlations Between BNA Latency Scores and Clinical, Cognitive, and Functionality Assessments Using Baseline Scores
Time frame: Baseline to Endpoint (8 weeks)

Results and safety

Results posted to the registry on 4 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vortioxetine	31	25

Primary outcome: Change in Montgomery and Asberg Depression Rating Scale (MADRS)

Time frame: from baseline to endpoint (up to 8 weeks). Mean (Full Range). Unit: score on a scale

Measure	Vortioxetine n = 25
Baseline	33.28 (24 to 40)
Week 8	16.23 (2 to 31)

Vortioxetine: p <0.001, Paired t-test

Population analysed: 25 subjects were included in the baseline analysis, and 22 subjects completed all visits and were included in subsequent analyses

Primary outcome: Change From Baseline to Endpoint in Digital Symbol Substitution Test.

Time frame: Baseline to endpoint (week 8). Mean (Full Range). Unit: number of correct symbols within 90 sec

Measure	Vortioxetine n = 25
Baseline	48.24 (30 to 65)
Endpoint (week 8)	55.55 (30 to 73)

Vortioxetine: p = 0.012, Paired t-test

Population analysed: 25 subjects were included in the baseline analysis, and 22 subjects completed all visits and were included in subsequent analyses

Primary outcome: BNA Scores Amplitudes

Time frame: Baseline to Endpoint (8 weeks). Mean (Standard Deviation). Unit: microvolts

Measure	Vortioxetine n = 25
AOB P200 amplitude Baseline	4.04 (2.60)
AOB P200 amplitude Endpoint (8 weeks)	3.96 (2.31)
AOB P3a amplitude Baseline	9.43 (5.00)
AOB P3a amplitude Endpoint (8 weeks)	7.13 (4.10)
AOB P3b amplitude Baseline	6.48 (3.69)
AOB P3b amplitude Endpoint (8 weeks)	6.75 (4.30)
VGNG P200 amplitude Baseline	3.40 (1.37)
VGNG P200 amplitude Endpoint (8 weeks)	3.66 (1.53)

Vortioxetine: Pearson's R: 0.125, p = 0.610, Pearson's correlation
Vortioxetine: Pearson's R: -0.294, p = 0.288, Pearson's correlation
Vortioxetine: Pearson's R: -0.405, p = 0.134, Pearson's correlation

Primary outcome: BNA Scores Latencies

Time frame: Baseline to Endpoint (8 weeks). Mean (Standard Deviation). Unit: milliseconds

Measure	Vortioxetine n = 25
AOB P200 latency Baseline	177.37 (12.66)
AOB P200 latency Endpoint (8 weeks)	177.90 (14.12)
AOB P3a latency Baseline	308.47 (50.93)
AOB P3a latency Endpoint (8 weeks)	281.38 (40.63)
AOB P3b latency Baseline	370.07 (55.87)
AOB P3b latency Endpoint (8 weeks)	367.27 (37.59)
VGNG P200 latency Baseline	170.35 (14.05)
VGNG P200 latency Endpoint (8 weeks)	172.11 (16.35)

Vortioxetine: Pearson's R: 0.359, p = 0.143, Pearson's correlation
Vortioxetine: Pearson's R: -0.197, p = 0.500, Pearson's correlation
Vortioxetine: Pearson's R: 0.277, p = 0.337, Pearson's correlation

Population analysed: These correlation analyses were done only on participants in the vortioxetine arm and did not include the group of healthy controls

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vortioxetine	0 of 25 (0%)	9 of 25 (36%)	0 of 25

Limitations and caveats (from the sponsor): Secondary outcomes #4 and #7, part c were not included in the results section for the following reasons: analysis became too complex based on low sample size; too many subgroups were needed. There were changes in BNA regardless of changes in symptoms and couldn't isolate meaningful or clinical useful data. In addition, several cognitive and functionality scores (i.e., CGI-I, TMT, UPSA, Stroop) were not collected at baseline and therefore not included in the "correlation with BNA" analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John M Zajecka, MD principal investigator

Rush University Medical Center

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing vortioxetine in people with Major Depressive Disorder, run by Rush University Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Montgomery and Asberg Depression Rating Scale (MADRS) (time frame: from baseline to endpoint (up to 8 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02749721.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021.