- 2023 Annual Meeting
- The PCORI Strategic Plan
- Clinical Effectiveness and Decision Science
- Dissemination and Implementation
- Evaluation and Analysis
- Healthcare Delivery and Disparities Research
- PCOR Infrastructure & Innovation
- Our Vision & Mission
- Financial Statements and Reports
- The PCORI Strategic Plan
- Board of Governors
- Methodology Committee
- Authorizing Law
- Evaluating Our Work
- PCORI's Advisory Panels
- Procurement Opportunities
Past Opportunities to Provide Input
- Stakeholder Views on Components of 'Patient-Centered Value' in Health and Health Care (2023)
- PCORI's Proposed Research Agenda (2021-2022)
- Proposed National Priorities for Health (2021)
- Proposed Principles for the Consideration of the Full Range of Outcomes Data in PCORI-Funded Research (2020)
- Proposed New PCORI Methodology Standards (2018)
- Data Access and Data Sharing Policy: Public Comment (2017)
- Proposed New PCORI Methodology Standards (2017)
Comment on the Proposed New and Revised PCORI Methodology Standards (2016)
- 1. Standards for Formulating Research Questions
- 10: Standards for Studies of Diagnostic Tests
- 12. Standards on Research Designs Using Clusters
- 13: General Comments on the Proposed Revisions to the PCORI Methodology Standards
- 2: Standards Associated with Patient-Centeredness
- 3: Standards for Data Integrity and Rigorous Analysis
- 4: Standards for Preventing and Handling Missing Data
- 5: Standards for Heterogeneity of Treatment Effects
- 6: Standards for Data Registries
- 7: Standards for Data Networks as Research-Facilitating Structures
- 8. Standards for Causal Inference Methods
- 9. Standards for Adaptive Trial Designs
- Peer-Review Process Comments (2014)
- Draft Methodology Report Public Comment Period (2012)
- Past Opportunities to Provide Input
An estimated one in three people with clinical depression do not respond to antidepressants, limiting their treatment option to electroconvulsive therapy (ECT), which has been linked to physical and mental side effects and social stigma.
However, the PCORI-funded ELEKT-D study team reported that patients with nonpsychotic, treatment-resistant depression who received ketamine intravenously fared just as well as those who received ECT. The findings were published in the New England Journal of Medicine.
In the clinical trial with 365 participants—which took place between March 2017 and September 2022 at five sites—55 percent of those receiving ketamine and 41 percent of those receiving ECT reported at least a 50 percent improvement in their depressive symptoms. The ketamine treatments caused fewer side effects and they were easier to administer to participants.
While the U.S. Food and Drug Administration has not approved ketamine as a treatment for psychiatric disorders, it has been approved as a sedative and general anesthetic. Previous studies have found the drug to have rapid antidepressant effects on people with treatment-resistant depression, but those studies did not conduct a comparison with ECT.
Principal investigator Amit Anand, M.D.—who is at Mass General Brigham/Harvard Medical School in Massachusetts—was at Cleveland Clinic in Ohio when the study was funded.
- Rapid Reversal of Acute Suicidal Depression across the Lifespan: A Pragmatic Comparative Effectiveness Trial of Electroconvulsive Therapy vs. Intravenous Ketamine Treatment
Posted: June 5, 2023
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