Depression Clinical Trial
Official title:
A Prospective Study to Evaluate the Utility, Safety, and Efficacy of Using PEER Interactive to Inform the Prescription of Medications to Subjects With a Primary Diagnosis of a Depressive Disorder and Comorbidity of Non-psychotic Behavioral Disorders
This is a prospective, single-blinded, randomized, multicenter study to evaluate the utility, safety, and efficacy of using PEER Interactive - an EEG-based technology - to inform the prescription of medications to participants with a primary diagnosis of a depressive disorder, with or without comorbidity of non-psychotic behavioral disorders, versus treatment as usual.
This study is observational in nature, in that the participants in the control group will be
treated according to treatment as usual and best judgment of the treating clinician. The
participants in the experimental group will be treated with adjunctive information provided
by the PEER Interactive Report. It is a controlled study in that the schedule of visits,
procedures and measurements will be defined by the protocol in order to provide consistent
data for both the control and experimental groups.
Participants will be blinded as to presence/use of the PEER Interactive Report and will
provide the primary efficacy outcome evaluation. All participants will be randomized into a
control or experimental group. All participants will receive a quantitative
electroencephalogram (QEEG). For those participants in the experimental group, the research
staff will receive an Outcome Report from PEER Interactive. The clinician in the experimental
group will use the PEER Interactive Report in the medication prescription process. For the
control group, the research staff will not receive an Outcome Report. Outcome Reports for the
control group will be sequestered for post-hoc analysis.
The research staff will incorporate the information provided by the Outcome Report from PEER
Interactive in their prescription decisions. PEER Interactive provides adjunctive information
to assist the treating clinician in the clinical decision process. For the experimental group
the research staff is expected to follow the guidance of the subject's PEER Outcome Report as
regards to the participant's responsiveness to the on-label medications noted in the Report.
Although the study staff is strongly encouraged to use the guidance in the medication
decision, prescription of medication is a clinical decision and will be made by the research
staff
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