Trial Outcomes & Findings for The Relationship Among Changes in Brain Network Activation in Adult Outpatients With Major Depressive Disorder (NCT NCT02749721)

Subjects were recruited from several sources, including referrals, advertisements and following completion of another clinical trial.

Participants were screened over a 1-2 week period to assess inclusion/exclusion criteria (i.e., to obtain lab results, to ensure adequate washout of any prohibited concomitant medications, etc).

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

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 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.

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).

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).

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.

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.

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.

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.

Pearson correlation was used to examine the associations between baseline BNA amplitude scores and outcomes including measures of MDD symptoms, cognitive function and functionality.

Pearson correlation was used to examine the associations between baseline BNA latency scores and outcomes including measures of MDD symptoms, cognitive function and functionality.