Excerpt

Aripiprazole, olanzapine, quetiapine, risperidone, and ziprasidone are atypical antipsychotics approved by the U.S. Food and Drug Administration (FDA) for treatment of schizophrenia and bipolar disorder. These drugs have been studied for off-label use in the following conditions: dementia and severe geriatric agitation, depression, obsessive-compulsive disorder, posttraumatic stress disorder, and personality disorders. The atypicals have also been studied for the management of Tourette’s syndrome and autism in children. The purpose of this report is to review the scientific evidence on the safety and effectiveness of such off-label uses.

Contents

• Preface
• Acknowledgments
• Executive Summary
• 1. Introduction
  • Background
  • Scope and Key Questions
• 2. Methods
  • Topic Development
  • Search Strategy
  • Technical Expert Panel
  • Study Selection
  • Data Abstraction
  • Adverse Events
  • Quality Assessment
  • Applicability
  • Rating the Body of Evidence
  • Data Synthesis
  • Peer Review
• 3. Results
  • Literature Flow
  • Key Question #1: What are the leading off-label uses of antipsychotics in the literature?
  • Key Question #2: What does the evidence show regarding the effectiveness of antipsychotics for off-label indications, such as depression? How do antipsychotic medications compare with other drugs for treating off-label indications?
  • Key Question 3: What subset of the population would potentially benefit from off-label uses?
  • Key Question 4. What are the potential adverse effects and/or complications involved with off-label antipsychotic prescribing?
  • Key Question 5. What is the appropriate dose and time limit for off-label indications?
• 4. Summary and Discussion
  • Limitations
  • Conclusions
• 5. Future Research
• References
• Appendixes
  • Appendix A Exact Search Strings
  • Appendix B Data Collection Forms
  • Appendix C Evidence and Quality Tables
  • Appendix D Excluded Articles
  • Appendix E Adverse Event Analysis

Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services.¹ Contract No. 290-02-0003. Prepared by: Southern California/RAND Evidence-based Practice Center.

Suggested citation:

Shekelle P, Maglione M, Bagley S, Suttorp M, Mojica WA, Carter J, Rolon C, Hilton L, Zhou A, Chen S, Glassman P. Comparative Effectiveness of Off-Label Use of Atypical Antipsychotics. Comparative Effectiveness Review No. 6. (Prepared by the Southern California/RAND Evidence-based Practice Center under Contract No. 290-02-0003.) Rockville, MD: Agency for Healthcare Research and Quality. January 2007. Available at: www.effectivehealthcare.ahrq.gov/reports/final.cfm.

None of the investigators has any affiliations or financial involvement that conflicts with the material presented in this report.

This report is based on research conducted by the Southern California/RAND Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-02-0003). The findings and conclusions in this document are those of the author(s), who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of the Agency for Healthcare Research and Quality or of the U.S. Department of Health and Human Services.

This report is intended as a reference and not as a substitute for clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information.

This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.

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