Depressive Disorder, MajorNCT03014544
Study to Evaluate the Performance Validity and Test-Retest Reliability of a Computer-Administered Cognitive Test Battery in Participants With Major Depressive Disorder (MDD)
An observational study of Depressive Disorder, Major, run by Janssen Research & Development, LLC at 20 sites in United States.
Trial summary
The purpose of this study is to examine concurrent validity of 8 computerized tests intended for the assessment of cognitive function in participants with Major Depressive Disorder (MDD), relative to 8 corresponding and previously validated examiner-administered cognitive tests. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Computer- administered test battery and Examiner- administered test battery
- Type of treatment
- Medical device
- How many people
- 585 participants
- Where
- 20 sitesUnited States
- Study dates
- 26 Oct 2016to 8 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants enrolled in substudy A and main study will be man or woman with major depressive disorder (MDD) and participants enrolled in substudy B will be healthy participants to evaluate cognitive performance at the clinic site.
Who may be able to join
- a) Substudy A and Main Study:
- Primary diagnosis of Major depressive disorder (MDD), made or confirmed by the investigator according to the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) criteria
- Demonstrated an adequate clinical response within the past 24 months, and is currently maintaining this response, to a stable oral antidepressant treatment regimen of no more than 2 of the following: selective serotonin reuptake inhibitor (SSRI), serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressants, in any formulation (fluvoxamine, citalopram, duloxetine, escitalopram, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine, vilazodone, or vortioxetine), or bupropion antidepressants, without any dosing changes for the most recent 6 weeks. The dose and duration of treatment will be documented by the investigator using the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ) and verified against the available medical and pharmacy records or medication bottles/package labels
- Required to have a Montgomery-Asberg Depression Rating Scale (MADRS) total score of less than or equal (<=)17 at screening and baseline (Test Day 1) visits as well as less than or equal (<=)19 during subsequent testing days (main study). Participants are also required to have a Clinical Global Impression - Severity (CGI-S) total score of <=3 during testing days (main study)
- Must have adequate visual and hearing acuity to perform all aspects of the cognitive and functional assessments as determined during physical examination
- b) Substudy B (Healthy Participants):
Show all 10Show fewer
- Must be healthy on the basis of physical examination, vital signs examination, and medical history performed at screening. This determination must be recorded in the participant's source documents and initialed by the investigator
- Body mass index (weight [kilogram (kg)]/height^2 [meter (m)]^2) between 18 and 30 kg/m2 (inclusive)
- Blood pressure (after the participant is sitting for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) inclusive, systolic, and no higher than 90 mmHg diastolic
- Must sign an Informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
Who cannot join
- a) Substudy A and Main Study:
- Has any of the following acute or chronic psychiatric conditions, according to Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) criteria: Major depressive disorder (MDD) with psychotic features (lifetime), bipolar disorder (including lifetime diagnosis), obsessive-compulsive disorder, post-traumatic stress disorder, borderline personality disorder, anorexia nervosa, schizophrenia, schizoaffective disorder, or minor and major neurocognitive disorders (including dementia)
- History of any acute or chronic neurological condition (for example (eg), stroke, epilepsy, Parkinson's disease)
- b) Substudy B (Healthy Participants):
- History of drug or alcohol abuse, with a severity of at least moderate or severe, according to DSM-5 criteria, within 6 months before screening or positive test result(s) for alcohol or drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines) at screening or admission on Day 1
- Participant has clinically significant liver or renal insufficiency; cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances. A significant primary sleep disorder is exclusionary, including primary insomnia and hypersomnia, narcolepsy, breathing-related sleep disorders, circadian-rhythm sleep disorders, and dyssomnias not otherwise specified
- Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Study site
Allentown, Pennsylvania
Study site
Anaheim, California
Study site
Baltimore, Maryland
Study site
Beverly Hills, California
Study site
Birmingham, Alabama
Study site
Boston, Massachusetts
Study site
Buffalo, New York
Study site
Dallas, Texas
Study site
Denver, Colorado
Study site
Glendale, California
Study site
Hartford, Connecticut
Study site
Iowa City, Iowa
Study site
Jacksonville, Florida
Study site
Lincoln, Nebraska
Study site
Long Beach, California
Study site
Mount Kisco, New York
Study site
New York, New York
Study site
Saint Charles, Missouri
Study site
Salt Lake City, Utah
Study site
Temecula, California
About this study
Official title: A Randomized, Multicenter, Crossover Study to Assess the Performance Validity and Test-Retest Reliability of a Computer-Administered Cognitive Test Battery in Subjects With Major Depressive Disorder
The purpose of this study is to examine concurrent validity of 8 computerized tests intended for the assessment of cognitive function in participants with Major Depressive Disorder (MDD), relative to 8 corresponding and previously validated examiner-administered cognitive tests.
- Conditions
- Depressive Disorder, Major
- Being tested
- Computer- administered test battery, Examiner- administered test battery
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer- administered test batteryDevice
Also called REVERE.D
Participants in this observational study will only undergo sequential cognitive performance evaluations by computer- administered cognitive test battery.
Examiner- administered test batteryDevice
Participants in this observational study will only undergo sequential cognitive performance evaluations by examiner- administered cognitive test battery.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Sequence AABB | Participants of main study with Major Depressive Disorder (MDD) will be assigned in test sequence group AABB (Group 1) to undergo sequential cognitive performance evaluations by Test A (Computer- administered test battery) on Test Day 1 (Study Day 1) and Test Day 2 (Study Day 15 to 22) followed by Test B (Examiner-administered test battery) on Test Day 3 (Study Day 29 to 43) and Test Day 4 (Study Day 43 to 64). Each separated by a memory washout period of 14 to 21 days. Receives: Device: Computer- administered test battery; Device: Examiner- administered test battery | |
| Group 2: Sequence BBAA | Participants of main study with MDD will be assigned in test sequence group BBAA (Group 2) to undergo sequential cognitive performance evaluations by Test B (Examiner-administered test battery) on Test Day 1 (Study Day 1) and Test Day 2 (Study Day 15 to 22) followed by Test A (Computer- administered test battery) on Test Day 3 (Study Day 29 to 43) and Test Day 4(Study Day 43 to 64). Each separated by a memory washout period of 14 to 21 days. Receives: Device: Computer- administered test battery; Device: Examiner- administered test battery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Score on a Cognitive Test Battery Evaluated by Symbol Sorting Test (SST)
The SST is designed as a measure of executive function. The SST requires the participant to sort symbols, based on symbol features such as color, shape, and number. No sorting criteria are provided to participants, rather the participant is provided feedback whether his/her response is correct or incorrect. Responses will be scored for Categories Achieved and Percent Perseverative Errors by computerized cognitive test battery.
Measured: Up to Test Day 4 (Day 43 to 64)
Performance Score on a Cognitive Test Battery Evaluated by Digit Span Forward Test (DSFT)
The DSFT is a widely used measure of attention and working memory, with versions included in a number of cognitive test batteries. The DSFT measures aspects of attention (freedom from distractibility) and working memory, and has been shown to be impaired in participants with MDD. The participant is asked to repeat a sequence of digits in the order presented. Participant will respond by pressing the keys on a keypad that correspond to the digits recalled. Two points will be given if the participant moves to the next sequence of digits with 1 attempt; 1 point will be given if the participant moves to the next sequence with 2 attempts; and 0 points will be given if the participant fails both attempts for a particular span. The score is the sum of correct responses. The length of the longest span of digits recalled will be used as a secondary score (up to 9).
Measured: Up to Test Day 4 (Day 43 to 64)
Performance Score on a Cognitive Test Battery Evaluated by Digit Span Backward Test (DSBT)
The DSBT is a widely used measure of attention and working memory, with versions included in a number of cognitive test batteries. The DSBT is thought to be a more complex span task than the DSFT as it also measures spatial/visual processing, and has been shown to be impaired in participants with MDD. The participant is asked to repeat a sequence of digits in reverse from the order presented. Participant will respond by pressing the keys on a keypad that correspond to the digits recalled in reverse order. Two points will be given if the participant moves to the next sequence of digits with 1 attempt; 1 point will be given if the participant moves to the next sequence with 2 attempts; and 0 points will be given if the participant fails both attempts for a particular span. The score is the sum of correct responses. The length of the longest span of digits recalled (backwards) will be used as a secondary score (up to 8).
Measured: Up to Test Day 4 (Day 43 to 64)
Performance Score on a Cognitive Test Battery Evaluated by Word List Recall Test (WLRT)
The WLRT used for the computerized test battery that measures person's ability to encode, consolidate, store, and retrieve verbal information and is a sensitive test of verbal learning and memory in a variety of disease states, including MDD. The memory test will include a list of 15 words presented aloud, one at a time, through the iPad. After the 15-word list is presented, the participant will be asked to verbally recall as many of the words as possible. The 15 word list and participant recall will be conducted 4 more times (total 5 times). After the 5th learning trial and recall, performance on the learning trials of the original word list and on the delayed recall will be considered as the primary scores. The participant's responses during the WLRT will be recorded and scored using 2 methods: by the speech recognition engine (SRE) and by an on-site test supervisor who will record the responses directly on the Revere.D application from a touch screen on the iPad.
Measured: Up to Test Day 4 (Day 43 to 64)
Performance Score on a Cognitive Test Battery Evaluated by Visuospatial Block Recall Test (VBRT)
The VBRT is based on a visuospatial learning test that requires participants to recall the location of colored tiles within an onscreen grid. Performance on visuospatial recall tasks has been shown to be lowered in anxious, depressed, or older healthy participants, as well as in participants with mild traumatic brain injury, schizophrenia, and acquired immune deficiency syndrome (AIDS) dementia complex. The participant is shown a sequence of on screen grids on which an increasingly complex pattern of colored tiles is depicted. Each pattern displays for only a brief period (0.5 seconds), after which participants are asked to recall the pattern. Recall accuracy (the number of correctly recalled patterns) is recorded by computerized cognitive test battery.
Measured: Up to Test Day 4 (Day 43 to 64)
Performance Score on a Cognitive Test Battery Evaluated by Symbol Digit Matching Test (SDMaT)
The SDMaT measures the time to pair abstract symbols with specific numbers. The test includes a coding key consisting of 9 abstract symbols, each paired with a number ranging from 1 to 9. Following the key, the participant is presented with randomly ordered symbols and is required to enter the number corresponding to each symbol as fast as possible using a keypad. The number of correct digit entries within 90 seconds is recorded by computerized cognitive test battery .
Measured: Up to Test Day 4 (Day 43 to 64)
Performance Score on a Cognitive Test Battery Evaluated by Trail Making Test Form B (TMT-B)
The computerized (Revere.D) version of the TMT-B is modeled after the paper-and-pencil version of the test. The TMT-B measures divided attention and executive function (tracking and sequencing). The participant is instructed to draw a line to connect a set of 25 consecutively numbered and lettered circles, alternating sequentially between numbers and letters (that is, 1 A 2 B). The participant is instructed to work as quickly as possible while still maintaining accuracy. The TMT-B has acceptable reliability; reliability coefficients have typically been reported as exceeding 0.65. The TMT-B is sensitive to cognitive decline associated with MDD.
Measured: Up to Test Day 4 (Day 43 to 64)
Performance Score on a Cognitive Test Battery Evaluated by Block Maze Test (BMT)
The BMT used in this study is modeled after published maze learning tests, such as the Groton Maze Learning Test, that assess processing speed, working memory, spatial learning, and error monitoring. In the BMT, the participant learns over 13 trials to navigate a path across tiles from a starting position to a target position using a set of predefined rules. The primary measure is total number of errors made in the 3 trials; the total time required for correct completion of the 3 trials will be used as a secondary score that will be evaluated by computerized cognitive test battery.
Measured: Up to Test Day 4 (Day 43 to 64)
Performance Score on a Cognitive Test Battery Evaluated by Rey Auditory Verbal Learning Test (RAVLT)
The RAVLT is a commonly used measure of a person's ability to encode, consolidate, store, and retrieve verbal information and is a sensitive test of verbal learning and memory in a variety of disease states, including MDD. The test will be administered by an examiner who will read the words aloud to the participant . The memory test will include a list of 15 words presented one at a time verbally by the examiner. After the 15-word list is presented, the participant will be asked to verbally recall as many of the words as possible. The 15 word list and participant recall will be conducted 4 more times (total 5 times). After the 5th learning trial and recall performance on the learning trials of the original word list and on the delayed recall will be considered as the primary scores that will be evaluated by examiner-administered cognitive test battery.
Measured: Up to Test Day 4 (Day 43 to 64)
Performance Score on a Cognitive Test Battery Evaluated by Brief Visuospatial Memory Test-Revised (BVMT-R)
The BVMT-R is a test of visual learning and recall. Participants are presented with 6 geometric figures in a 2*3 visual array; presentation is on a sheet of paper for a 10 second exposure. Participants are asked to draw as many figures in their proper locations as they remember, for each of 3 learning trials. The test has good test-retest reliability; r [greater than (>)]0.96 for the learning trials. The BVMT-R is included in the MATRICS Consensus Cognitive Battery. The total recall score will be used in this study that will be evaluated by examiner-administered cognitive test battery.
Measured: Up to Test Day 4 (Day 43 to 64)
Performance Score on a Cognitive Test Battery Evaluated by Symbol Digit Modalities Test (SDMT)
The SDMT is a widely used, paper-and-pencil assessment of complex scanning and visual tracking, requiring elements of attention, visuoperceptual processing, working memory, and cognitive/psychomotor speed.The test is viewed as a robust screening test for adult neuropsychological impairment and has been used to demonstrate worse cognitive functioning in patients with MDD. The SDMT measures the time to pair abstract symbols with specific numbers. The test includes a coding key consisting of 9 abstract symbols, each paired with a number ranging from 1 to 9. Following the key, the participant is presented with randomly ordered symbols and is required to write the number corresponding to each symbol as fast as possible. The number of correct substitutions within 90 seconds is recorded by examiner-administered cognitive test battery.
Measured: Up to Test Day 4 (Day 43 to 64)
Performance Score on a Cognitive Test Battery Evaluated by Neuropsychological Assessment Battery - Maze Test (NAB-MT)
The NAB-MT is a test in which participants are asked to complete 7 increasingly complex paper-and-pencil mazes; scores include time to completion.The test assesses aspects of executive function, especially planning and foresight. It was standardized on a sample of more than 1,400 healthy adults. Extensive validation evidence has been established through exploratory and confirmatory factor analyses, criterion validity investigations, and several clinical validation studies. It has been used to demonstrate neurocognitive impairments in patients with depression. The NAB-MT is included in the MATRICS Consensus Cognitive Battery. The time to completion score will be used in this study that will be evaluated by examiner-administered cognitive test battery.
Measured: Up to Test Day 4 (Day 43 to 64)
Performance Score on a Cognitive Test Battery Evaluated by Wisconsin Card Sorting Test (WCST)
WCST is a widely used measure of executive function. WCST requires the participant to sort symbols based on symbol features such as color, shape and number without providing instructions as to matching criteria; rather the participant is provided feedback whether a particular match is right or wrong. Responses will be scored for Categories Achieved and Percent Perseverative Errors by examiner-administered cognitive test battery.
Measured: Up to Test Day 4 (Day 43 to 64)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study start26 Oct 2016
- Primary completion8 Apr 2019
- Study completion8 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 585 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014544
- Sponsor's protocol ID
- CR108211
- Other IDs
- NOPRODMDD0003
- Status last verified
- Apr 2025
- First submitted
- 18 Nov 2016
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Crossover Study to Assess the Performance Validity and Test-Retest Reliability of a Computer-Administered Cognitive Test Battery in Subjects With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT03014544
- Acronym / sponsor ID
- CR108211
- Conditions
- Depressive Disorder, Major
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 585 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2016 (actual)
- Primary completion
- 8 Apr 2019 (actual)
- Study completion
- 8 Apr 2019 (actual)
- First posted
- 9 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine concurrent validity of 8 computerized tests intended for the assessment of cognitive function in participants with Major Depressive Disorder (MDD), relative to 8 corresponding and previously validated examiner-administered cognitive tests.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Sequence AABB | – | Device: Computer- administered test battery, Device: Examiner- administered test batteryParticipants of main study with Major Depressive Disorder (MDD) will be assigned in test sequence group AABB (Group 1) to undergo sequential cognitive performance evaluations by Test A (Computer- administered test battery) on Test Day 1 (Study Day 1) and Test Day 2 (Study Day 15 to 22) followed by Test B (Examiner-administered test battery) on Test Day 3 (Study Day 29 to 43) and Test Day 4 (Study Day 43 to 64). Each separated by a memory washout period of 14 to 21 days. |
| Group 2: Sequence BBAA | – | Device: Computer- administered test battery, Device: Examiner- administered test batteryParticipants of main study with MDD will be assigned in test sequence group BBAA (Group 2) to undergo sequential cognitive performance evaluations by Test B (Examiner-administered test battery) on Test Day 1 (Study Day 1) and Test Day 2 (Study Day 15 to 22) followed by Test A (Computer- administered test battery) on Test Day 3 (Study Day 29 to 43) and Test Day 4(Study Day 43 to 64). Each separated by a memory washout period of 14 to 21 days. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants enrolled in substudy A and main study will be man or woman with major depressive disorder (MDD) and participants enrolled in substudy B will be healthy participants to evaluate cognitive performance at the clinic site.
Key inclusion criteria (10 listed)
- a) Substudy A and Main Study:
- Primary diagnosis of Major depressive disorder (MDD), made or confirmed by the investigator according to the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) criteria
- Demonstrated an adequate clinical response within the past 24 months, and is currently maintaining this response, to a stable oral antidepressant treatment regimen of no more than 2 of the following: selective serotonin reuptake inhibitor (SSRI), serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressants, in any formulation (fluvoxamine, citalopram, duloxetine, escitalopram, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine, vilazodone, or vortioxetine), or bupropion antidepressants, without any dosing changes for the most recent 6 weeks. The dose and duration of treatment will be documented by the investigator using the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ) and verified against the available medical and pharmacy records or medication bottles/package labels
- Required to have a Montgomery-Asberg Depression Rating Scale (MADRS) total score of less than or equal (<=)17 at screening and baseline (Test Day 1) visits as well as less than or equal (<=)19 during subsequent testing days (main study). Participants are also required to have a Clinical Global Impression - Severity (CGI-S) total score of <=3 during testing days (main study)
- Must have adequate visual and hearing acuity to perform all aspects of the cognitive and functional assessments as determined during physical examination
Key exclusion criteria (7 listed)
- a) Substudy A and Main Study:
- Has any of the following acute or chronic psychiatric conditions, according to Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) criteria: Major depressive disorder (MDD) with psychotic features (lifetime), bipolar disorder (including lifetime diagnosis), obsessive-compulsive disorder, post-traumatic stress disorder, borderline personality disorder, anorexia nervosa, schizophrenia, schizoaffective disorder, or minor and major neurocognitive disorders (including dementia)
- History of any acute or chronic neurological condition (for example (eg), stroke, epilepsy, Parkinson's disease)
- b) Substudy B (Healthy Participants):
- History of drug or alcohol abuse, with a severity of at least moderate or severe, according to DSM-5 criteria, within 6 months before screening or positive test result(s) for alcohol or drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines) at screening or admission on Day 1
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 |
|---|---|---|
| Computer- administered test batteryAlso: REVERE.DParticipants in this observational study will only undergo sequential cognitive performance evaluations by computer- administered cognitive test battery. | Device | Group 1: Sequence AABB, Group 2: Sequence BBAA |
| Examiner- administered test batteryParticipants in this observational study will only undergo sequential cognitive performance evaluations by examiner- administered cognitive test battery. | Device | Group 1: Sequence AABB, Group 2: Sequence BBAA |
Primary outcome
Performance Score on a Cognitive Test Battery Evaluated by Symbol Sorting Test (SST)
Time frame: Up to Test Day 4 (Day 43 to 64)
The SST is designed as a measure of executive function. The SST requires the participant to sort symbols, based on symbol features such as color, shape, and number. No sorting criteria are provided to participants, rather the participant is provided feedback whether his/her response is correct or incorrect. Responses will be scored for Categories Achieved and Percent Perseverative Errors by computerized cognitive test battery.
Performance Score on a Cognitive Test Battery Evaluated by Digit Span Forward Test (DSFT)
Time frame: Up to Test Day 4 (Day 43 to 64)
The DSFT is a widely used measure of attention and working memory, with versions included in a number of cognitive test batteries. The DSFT measures aspects of attention (freedom from distractibility) and working memory, and has been shown to be impaired in participants with MDD. The participant is asked to repeat a sequence of digits in the order presented. Participant will respond by pressing the keys on a keypad that correspond to the digits recalled. Two points will be given if the participant moves to the next sequence of digits with 1 attempt; 1 point will be given if the participant moves to the next sequence with 2 attempts; and 0 points will be given if the participant fails both attempts for a particular span. The score is the sum of correct responses. The length of the longest span of digits recalled will be used as a secondary score (up to 9).
Performance Score on a Cognitive Test Battery Evaluated by Digit Span Backward Test (DSBT)
Time frame: Up to Test Day 4 (Day 43 to 64)
The DSBT is a widely used measure of attention and working memory, with versions included in a number of cognitive test batteries. The DSBT is thought to be a more complex span task than the DSFT as it also measures spatial/visual processing, and has been shown to be impaired in participants with MDD. The participant is asked to repeat a sequence of digits in reverse from the order presented. Participant will respond by pressing the keys on a keypad that correspond to the digits recalled in reverse order. Two points will be given if the participant moves to the next sequence of digits with 1 attempt; 1 point will be given if the participant moves to the next sequence with 2 attempts; and 0 points will be given if the participant fails both attempts for a particular span. The score is the sum of correct responses. The length of the longest span of digits recalled (backwards) will be used as a secondary score (up to 8).
Performance Score on a Cognitive Test Battery Evaluated by Word List Recall Test (WLRT)
Time frame: Up to Test Day 4 (Day 43 to 64)
The WLRT used for the computerized test battery that measures person's ability to encode, consolidate, store, and retrieve verbal information and is a sensitive test of verbal learning and memory in a variety of disease states, including MDD. The memory test will include a list of 15 words presented aloud, one at a time, through the iPad. After the 15-word list is presented, the participant will be asked to verbally recall as many of the words as possible. The 15 word list and participant recall will be conducted 4 more times (total 5 times). After the 5th learning trial and recall, performance on the learning trials of the original word list and on the delayed recall will be considered as the primary scores. The participant's responses during the WLRT will be recorded and scored using 2 methods: by the speech recognition engine (SRE) and by an on-site test supervisor who will record the responses directly on the Revere.D application from a touch screen on the iPad.
Performance Score on a Cognitive Test Battery Evaluated by Visuospatial Block Recall Test (VBRT)
Time frame: Up to Test Day 4 (Day 43 to 64)
The VBRT is based on a visuospatial learning test that requires participants to recall the location of colored tiles within an onscreen grid. Performance on visuospatial recall tasks has been shown to be lowered in anxious, depressed, or older healthy participants, as well as in participants with mild traumatic brain injury, schizophrenia, and acquired immune deficiency syndrome (AIDS) dementia complex. The participant is shown a sequence of on screen grids on which an increasingly complex pattern of colored tiles is depicted. Each pattern displays for only a brief period (0.5 seconds), after which participants are asked to recall the pattern. Recall accuracy (the number of correctly recalled patterns) is recorded by computerized cognitive test battery.
Performance Score on a Cognitive Test Battery Evaluated by Symbol Digit Matching Test (SDMaT)
Time frame: Up to Test Day 4 (Day 43 to 64)
The SDMaT measures the time to pair abstract symbols with specific numbers. The test includes a coding key consisting of 9 abstract symbols, each paired with a number ranging from 1 to 9. Following the key, the participant is presented with randomly ordered symbols and is required to enter the number corresponding to each symbol as fast as possible using a keypad. The number of correct digit entries within 90 seconds is recorded by computerized cognitive test battery .
Performance Score on a Cognitive Test Battery Evaluated by Trail Making Test Form B (TMT-B)
Time frame: Up to Test Day 4 (Day 43 to 64)
The computerized (Revere.D) version of the TMT-B is modeled after the paper-and-pencil version of the test. The TMT-B measures divided attention and executive function (tracking and sequencing). The participant is instructed to draw a line to connect a set of 25 consecutively numbered and lettered circles, alternating sequentially between numbers and letters (that is, 1 A 2 B). The participant is instructed to work as quickly as possible while still maintaining accuracy. The TMT-B has acceptable reliability; reliability coefficients have typically been reported as exceeding 0.65. The TMT-B is sensitive to cognitive decline associated with MDD.
Performance Score on a Cognitive Test Battery Evaluated by Block Maze Test (BMT)
Time frame: Up to Test Day 4 (Day 43 to 64)
The BMT used in this study is modeled after published maze learning tests, such as the Groton Maze Learning Test, that assess processing speed, working memory, spatial learning, and error monitoring. In the BMT, the participant learns over 13 trials to navigate a path across tiles from a starting position to a target position using a set of predefined rules. The primary measure is total number of errors made in the 3 trials; the total time required for correct completion of the 3 trials will be used as a secondary score that will be evaluated by computerized cognitive test battery.
Performance Score on a Cognitive Test Battery Evaluated by Rey Auditory Verbal Learning Test (RAVLT)
Time frame: Up to Test Day 4 (Day 43 to 64)
The RAVLT is a commonly used measure of a person's ability to encode, consolidate, store, and retrieve verbal information and is a sensitive test of verbal learning and memory in a variety of disease states, including MDD. The test will be administered by an examiner who will read the words aloud to the participant . The memory test will include a list of 15 words presented one at a time verbally by the examiner. After the 15-word list is presented, the participant will be asked to verbally recall as many of the words as possible. The 15 word list and participant recall will be conducted 4 more times (total 5 times). After the 5th learning trial and recall performance on the learning trials of the original word list and on the delayed recall will be considered as the primary scores that will be evaluated by examiner-administered cognitive test battery.
Performance Score on a Cognitive Test Battery Evaluated by Brief Visuospatial Memory Test-Revised (BVMT-R)
Time frame: Up to Test Day 4 (Day 43 to 64)
The BVMT-R is a test of visual learning and recall. Participants are presented with 6 geometric figures in a 2*3 visual array; presentation is on a sheet of paper for a 10 second exposure. Participants are asked to draw as many figures in their proper locations as they remember, for each of 3 learning trials. The test has good test-retest reliability; r [greater than (>)]0.96 for the learning trials. The BVMT-R is included in the MATRICS Consensus Cognitive Battery. The total recall score will be used in this study that will be evaluated by examiner-administered cognitive test battery.
Performance Score on a Cognitive Test Battery Evaluated by Symbol Digit Modalities Test (SDMT)
Time frame: Up to Test Day 4 (Day 43 to 64)
The SDMT is a widely used, paper-and-pencil assessment of complex scanning and visual tracking, requiring elements of attention, visuoperceptual processing, working memory, and cognitive/psychomotor speed.The test is viewed as a robust screening test for adult neuropsychological impairment and has been used to demonstrate worse cognitive functioning in patients with MDD. The SDMT measures the time to pair abstract symbols with specific numbers. The test includes a coding key consisting of 9 abstract symbols, each paired with a number ranging from 1 to 9. Following the key, the participant is presented with randomly ordered symbols and is required to write the number corresponding to each symbol as fast as possible. The number of correct substitutions within 90 seconds is recorded by examiner-administered cognitive test battery.
Performance Score on a Cognitive Test Battery Evaluated by Neuropsychological Assessment Battery - Maze Test (NAB-MT)
Time frame: Up to Test Day 4 (Day 43 to 64)
The NAB-MT is a test in which participants are asked to complete 7 increasingly complex paper-and-pencil mazes; scores include time to completion.The test assesses aspects of executive function, especially planning and foresight. It was standardized on a sample of more than 1,400 healthy adults. Extensive validation evidence has been established through exploratory and confirmatory factor analyses, criterion validity investigations, and several clinical validation studies. It has been used to demonstrate neurocognitive impairments in patients with depression. The NAB-MT is included in the MATRICS Consensus Cognitive Battery. The time to completion score will be used in this study that will be evaluated by examiner-administered cognitive test battery.
Performance Score on a Cognitive Test Battery Evaluated by Wisconsin Card Sorting Test (WCST)
Time frame: Up to Test Day 4 (Day 43 to 64)
WCST is a widely used measure of executive function. WCST requires the participant to sort symbols based on symbol features such as color, shape and number without providing instructions as to matching criteria; rather the participant is provided feedback whether a particular match is right or wrong. Responses will be scored for Categories Achieved and Percent Perseverative Errors by examiner-administered cognitive test battery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- To learn how to participate in this trial please click here.Link provided by the sponsor.
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder, Major, run by Janssen Research & Development, LLC at 20 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 10 inclusion and 7 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 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Performance Score on a Cognitive Test Battery Evaluated by Symbol Sorting Test (SST) (time frame: Up to Test Day 4 (Day 43 to 64)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2025.