This is a prospective, multicenter, randomized, double-blind, controlled study to evaluate the effectiveness of Psychiatric Electroencephalogram Registry (PEER) Interactive to inform medication prescription in subjects with a primary diagnosis of depression with comorbidity of non-psychotic behavioral disorders versus treatment as usual, as determined by the investigator. The primary measurement for improvement of the subjects depression will be a self-evaluation questionnaire, the Quick Inventory of Depressive Symptomatology-Self Report 16 , but the investigators will also collect information on their clinical global improvement and any reduction in adverse events.
This study is prospective in nature. Subjects in the control group will be treated according to treatment as usual and best judgment of the treating physician. For the experimental group the treating physician will follow the guidance of the subject's PEER Interactive Report as regards sensitivity to on-label medications and classes of medication. The subjects will be washed out of all current medications prior to having an electroencephalogram (EEG), which is necessary to generate the PEER Interactive Report. The wash out period for outpatients is no longer than 14 days. The subjects will be followed for 3 months after the initial treatment. The patient will be seen on a routine basis and assessments will be made at each interaction to evaluate the patient's improvement in mental health. The subjects will also be closely evaluated to determine if they are experiencing any psychiatric specific adverse events. The investigator is allowed to treat the patient according to their best medical judgment, which may include adding or changing medications, seeing the patient more frequently, or other interventions such as the use of sleep aids.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
468
A subinvestigator treating a Treatment Group subject will receive the Psychiatric Electroencephalogram Evaluation Registry (PEER) Interactive Report (of probable medication response) under investigation and will incorporate the Report information during prescription of medications to the Subject. A subinvestigator treating a Control Group subject will NOT receive the PEER Report and will treat the Subject with Standard of Care. The subject will be blinded to group assignment and will provide the primary outcome measure - Quick Inventory of Depressive Symptomatology - Self Report 16 item questionnaire.
Carolina Partners
Raleigh, North Carolina, United States
Quick Inventory of Depressive Symptomatology - Self Report 16 questionnaire (QIDS-SR16)
A self reported survey - blinded subject acts as blinded rater/outcomes assessor. We will use this survey to measure the subject's self-reported change in symptoms of depression.
Time frame: 4 months
Clinical Global Impressions - Improvement (CGI-I)
Commonly used measure of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders
Time frame: 4 months
Clinical Global Impressions - Severity (CGI-S)
Commonly used measure of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders.
Time frame: 4 months
Concise Health Risk Tracking Scale - 7 item Self Report Survey (CHRT- SR7)
A 7 question self-report questionnaire that assesses suicidal risk of subjects in clinical practice
Time frame: 4 months
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