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Project

Treatment of Depression Post-SCI: Retrospective Analysis and Feasibility Trial

Funder: Craig H Neilsen Foundation

Funding period
USD 150 K
Funding amount
Abstract
Depression is one of the most prevalent neuropsychiatric disorders after spinal cord injury (SCI). Depression and specifically major depressive disorder (MDD) post-SCI has been associated with poorer health, spending more time in bed, increased pressure sores and even higher mortality. Despite these associated negative sequelae, there are no current guidelines for the treatment of MDD post-SCI and the current literature is sparse regarding the effectiveness of available treatment options. Thus, the overarching goal of this proposal is to begin addressing these limitations by examining current practice patterns for the treatment of MDD post-SCI using retrospective analyses of insurance claims data and to trial repetitive transcranial magnetic stimulation (rTMS) for the treatment of MDD in individuals post-SCI. Due to the lack of treatment guidelines, it is unknown how MDD is currently treated clinically. The first two Aims of this proposed study will use the MarketScan® Database from 2013 – 2016 to explore how MDD is currently treated post-SCI. Data regarding inpatient, outpatient, and pharmacy claims and encounters for individuals with an index SCI in 2013, 2014, and 2015 and MDD diagnose post-SCI will be extracted. According the American Psychiatric Association’s (APA) treatment guidelines for MDD, treatment options include antidepressants, psychotherapy services, and non-invasive brain stimulation, including electroconvulsive therapy (ECT) and rTMS. Through the use of claims and encounters, the frequency and duration of claims for antidepressants, psychotherapy services, ECT and rTMS will be determined. The use of antidepressants will also be investigated further by assessing the specific types of medication, dosages, and number of pills within each claim by using the National Drug Codes. The findings will be compared to the APA guidelines to determine if current clinical practice patterns meet these guidelines. The last Aim of this proposed study builds upon the exploration of the treatment of MDD post-SCI. As stated earlier, there is limited literature regarding the effectiveness of different MDD treatment techniques post-SCI, despite the known effectiveness in other cohorts. Therefore, a small pilot, clinical trial will be completed to assess the safety, feasibility, and impact of rTMS for MDD post-SCI. Twelve participants with a cervical or thoracic level SCI and MDD, identified by the Patient Health Questionaire-9, will complete 20 sessions (5 times/week for 4 weeks) of rTMS according the Food and Drug Administration protocol. Outcomes at the end of 4 weeks will include safety based upon adverse events, feasibility based upon attendance and attrition rates, and changes in depressive symptoms. The data generated from this study will inform clinicians, patients, caregivers, and other researchers about current clinical practice patterns for treating MDD post-SCI compared to standard guidelines and lead to informed changes. Additionally, this research will be used to support larger clinical trials assessing rTMS for MDD post-SCI, with studies focused on effectiveness, dosing, and clinical application as warranted. (CHN: PSR chn:wdg)
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System

Categories
  • FOR (ANZSRC)

    1103 Clinical Sciences

  • FOR (ANZSRC)

    1117 Public Health and Health Services

  • RCDC

    Injury (total) Accidents/Adverse Effects

  • RCDC

    Injury - Trauma - (Head and Spine)

  • RCDC

    Mental Health

  • RCDC

    Neurosciences

  • RCDC

    Depression

  • RCDC

    Rehabilitation

  • RCDC

    Spinal Cord Injury

  • RCDC

    Behavioral and Social Science

  • RCDC

    Brain Disorders

  • RCDC

    Clinical Research

  • RCDC

    Clinical Trials and Supportive Activities

  • RCDC

    Comparative Effectiveness Research

  • RCDC

    Neurodegenerative

  • RCDC

    Patient Safety

  • RCDC

    Serious Mental Illness

  • HRCS HC

    Mental Health

  • HRCS RAC

    6.6 Psychological and behavioural

  • Health Research Areas

    Clinical

  • Broad Research Areas

    Clinical Medicine and Science