Study to Evaluate the Performance Validity and Test-Retest Reliability of a Computer-Administered Cognitive Test Battery in Participants With Major Depressive Disorder (MDD)

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Depressive Disorder, Major

Treatments: Device: Examiner- administered test battery; Device: Computer- administered test battery

Study type: Observational

Funder types: Industry

Identifiers

NCT03014544

NOPRODMDD0003 (Other Identifier)

CR108211

Details and patient eligibility

About

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.

Enrollment: 585 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

585 participants in 2 patient groups

Group 1: Sequence AABB

Description:

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.

Treatment:

Device: Computer- administered test battery

Device: Examiner- administered test battery

Group 2: Sequence BBAA

Description:

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.

Treatment:

Device: Computer- administered test battery

Device: Examiner- administered test battery