Clinical trial NCT03014544: Study to Evaluate the Performance Validity and Test-Retest Reliability of a Computer-Administered Cognitive Test Battery in Participants With Major Depressive Disorder (MDD)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depressive Disorder, Major
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2017-01-09
Enrollment: 585
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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):
* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Performance Score on a Cognitive Test Battery Evaluated by Symbol Sorting Test (SST)
timeFrame: Up to Test Day 4 (Day 43 to 64)
measure: Performance Score on a Cognitive Test Battery Evaluated by Digit Span Forward Test (DSFT)
timeFrame: Up to Test Day 4 (Day 43 to 64)
measure: Performance Score on a Cognitive Test Battery Evaluated by Digit Span Backward Test (DSBT)
timeFrame: Up to Test Day 4 (Day 43 to 64)
measure: Performance Score on a Cognitive Test Battery Evaluated by Word List Recall Test (WLRT)
timeFrame: Up to Test Day 4 (Day 43 to 64)
measure: Performance Score on a Cognitive Test Battery Evaluated by Visuospatial Block Recall Test (VBRT)
timeFrame: Up to Test Day 4 (Day 43 to 64)
measure: Performance Score on a Cognitive Test Battery Evaluated by Symbol Digit Matching Test (SDMaT)
timeFrame: Up to Test Day 4 (Day 43 to 64)
measure: Performance Score on a Cognitive Test Battery Evaluated by Trail Making Test Form B (TMT-B)
timeFrame: Up to Test Day 4 (Day 43 to 64)
measure: Performance Score on a Cognitive Test Battery Evaluated by Block Maze Test (BMT)
timeFrame: Up to Test Day 4 (Day 43 to 64)
measure: Performance Score on a Cognitive Test Battery Evaluated by Rey Auditory Verbal Learning Test (RAVLT)
timeFrame: Up to Test Day 4 (Day 43 to 64)
measure: Performance Score on a Cognitive Test Battery Evaluated by Brief Visuospatial Memory Test-Revised (BVMT-R)
timeFrame: Up to Test Day 4 (Day 43 to 64)
measure: Performance Score on a Cognitive Test Battery Evaluated by Symbol Digit Modalities Test (SDMT)
timeFrame: Up to Test Day 4 (Day 43 to 64)
measure: Performance Score on a Cognitive Test Battery Evaluated by Neuropsychological Assessment Battery - Maze Test (NAB-MT)
timeFrame: Up to Test Day 4 (Day 43 to 64)
measure: Performance Score on a Cognitive Test Battery Evaluated by Wisconsin Card Sorting Test (WCST)
timeFrame: Up to Test Day 4 (Day 43 to 64)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Anaheim
country: United States
state: California
city: Beverly Hills
country: United States
state: California
city: Glendale
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Temecula
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Hartford
country: United States
state: Connecticut
city: Jacksonville
country: United States
state: Florida
city: Iowa City
country: United States
state: Iowa
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Saint Charles
country: United States
state: Missouri
city: Lincoln
country: United States
state: Nebraska
city: Buffalo
country: United States
state: New York
city: Mount Kisco
country: United States
state: New York
city: New York
country: United States
state: New York
city: Allentown
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: