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PEER Interactive to Inform the Prescription of Medications

University of Ottawa · 2016
ClinicalTrials.gov · Datasets · License: Public Domain · 2016
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depression
Improving the prescription accuracy of psychotropic medications for military personnel diagnosed with neuropsychiatric disorders is imperative to promote accelerated treatment response and recovery. This study will determine whether PEER (Psychiatric EEG Evaluation Registry) Interactive (a comparison of a quantitative electroencephalogram (QEEG) to an existing database of subject outcomes) provides an objective adjunctive tool that is more effective in guiding treatment than the current standard of practice in the treatment of military personnel suffering from non-psychotic mental illness. For this prospective, multicenter, randomized, single-blinded, controlled study, 100 participants with a primary diagnosis of a DSM-V depressive disorder, with comorbidity of non-psychotic behavioral disorders to include mild Traumatic Brain Injury (mTBI) and Post Traumatic Stress Disorder (PTSD), will be enrolled. Participants will be randomized into a control or experimental group, and all will undergo a quantitative electroencephalogram (QEEG). For the experimental group, research staff will receive an Outcome Report from PEER Interactive and will follow the guidance of the Report to inform treatment. For the control group, research staff will not receive a participant Outcome Report from PEER Interactive and these participants will be treated based on current standards. For the control group, Outcome Reports will be sequestered for post-hoc analysis. Research staff in collaboration with CNS Response (the Sponsor) will evaluate and validate if the guidance provided by PEER Interactive correlates with the predicted participant outcome. Research staff in collaboration with the Sponsor will also evaluate if the treatment guidance provided by PEER Interactive results in improved mental health and/or a reduction of risk as measured by a reduction in severe adverse events, including suicidality.
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