Study Protocol CSP #556, “The Effectiveness Of

Study Protocol CSP #556, “The Effectiveness Of

Study Protocol CSP #556, “The Effectiveness of rTMS in Depressed VA Patients” Department of Veterans Affairs Cooperative Studies Program (VA CSP) Principal Investigator: Jerome A. Yesavage, MD Director, VISN 21 MIRECC Professor, Department of Psychiatry, Stanford University School of Medicine VA Palo Alto Health Care System 151Y 3801 Miranda Avenue Palo Alto, California 94304 Telephone: 650-852-3287 Fax: 650-852-3297 Co-chairs: J. Kaci Fairchild, Ph.D. VA Palo Alto Health Care System 151Y 3801 Miranda Avenue Palo Alto, CA 94304 Telephone: 650-493-5000 ext 63432 Fax: 650-852-3297 Mark S. George, MD Ralph H. Johnson VA Medical Center 109 Bee Street Charleston, SC Telephone: (843) 789-7316 x5275 or 843-876-5142 Fax: 843-792-5702 IDE Sponsor: Department of Veterans Affairs Cooperative Studies Program Sponsor's Representative: Anne H. Davis-Karim, PharmD VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center 2401 Centre Avenue SE Albuquerque, NM 87106-4180 Phone: 505-248-3200 Fax: 505-248-3205 TABLE OF CONTENTS VOLUME I Page List of Abbreviations .............................................................................................................. 1 Executive Summary ............................................................................................................. 5 Protocol ................................................................................................................................ 8 I. Introduction and Background ........................................................................................ 8 A. Importance of Treating Treatment-Resistant Major Depression (TRMD) ............ 8 B. Overview of rTMS in TRMD ................................................................................. 8 C. Special Considerations for Gender and Ethnic Disparities ................................ 10 D. Physics of rTMS ................................................................................................ 11 E. General Description of rTMS Procedure and Determination of Motor Threshold (MT) .................................................................................................. 12 F. rTMS Safety ...................................................................................................... 14 G. Efficacy of rTMS and Meta-analyses ................................................................. 15 H. Overall Assessment of Effect Size and Assessment of Potential Clinical Impact ................................................................................................... 16 I. Justification of the Need within the VA .............................................................. 17 1. Assessing Effect on Suicidality .............................................................. 18 2. The Special VA Dual-Diagnoses Population ........................................... 18 3. Economic Issues and Accessibility of Care ............................................ 19 J. Summary Statement of Background and Rationale ........................................... 20 II. Study Objectives ......................................................................................................... 21 A. Primary Objective .......................................................................................... 21 B. Secondary Objectives ................................................................................... 21 III. Outcome Measures ..................................................................................................... 22 A. Primary ........................................................................................................ 22 B. Secondary ..................................................................................................... 22 IV. Study Design ............................................................................................................... 23 V. Patient Population ....................................................................................................... 23 A. Inclusion Criteria ........................................................................................... 23 B. Exclusion Criteria .......................................................................................... 24 VI. Methodology ................................................................................................................ 26 A. Recruitment .................................................................................................. 26 B. Screening Assessments ............................................................................... 29 C. Randomization to Treatment ......................................................................... 29 D. Duration of the Study .................................................................................... 30 E. Intervention Procedure .................................................................................. 31 F. Treatment Regimen ...................................................................................... 33 G. Study Assessments ...................................................................................... 37 H. Adverse Events (AE) and Adverse Device Effects (ADE) ............................. 48 I. Dropouts and Follow-Up Procedures ............................................................ 53 J. Missed Visits and Study Termination ............................................................ 54 K. Follow-up Procedures for Non-Remitters and Non-Responders ................... 54 L. Protocol Violations ........................................................................................ 54 M. Participant Compensation ............................................................................. 55 N. Genetics [Section Removed] ......................................................................... 55 VII. Data Management and Case Report Forms ............................................................... 55 A. Assessments, Case Report Forms & Frequencies of Collection ................... 55 B. Data Collection and Data Entry ..................................................................... 55 C. Study Documentation and Records Retention .............................................. 56 D. Data Security Plan ........................................................................................ 57 VIII. Biostatistical Consideration ......................................................................................... 58 A. Sample Size .................................................................................................. 58 B. Analysis Plan ................................................................................................ 58 C. Additional Analyses ....................................................................................... 59 D. Assessing Size of Treatment Effect .............................................................. 61 E. Supplemental Statistical Analyses ................................................................ 62 F. Economic Analysis ........................................................................................ 62 IX. Quality Assurance Procedures .................................................................................... 63 A. Rater Training ............................................................................................... 63 B. Good Clinical Practices ................................................................................. 63 X. Study Management, Monitoring and Training .............................................................. 64 A. Study Management ....................................................................................... 64 B. Monitoring ..................................................................................................... 67 C. Training ......................................................................................................... 77 XI. Research Results and Confidentiality ........................................................................ 78 A. Confidentiality ............................................................................................... 78 B. Publication of Research Results ................................................................... 78 C. Planned Publications .................................................................................... 80 XII. References .................................................................................................................. 80 APPENDICES Appendix A Human Rights Issues and Informed Consent ................................................. A1 Appendix B Budget ............................................................................................................ B1 Appendix C Curricula Vitae ............................................................................................... C1 Appendix D Biostatistical and Research Data Processing Procedure .............................. D1 VOLUME II Appendix E Research Data Forms .................................................................................... E1 Appendix F Device Handling Procedures ........................................................................... F1 Appendix G Investigator’s Brochure (Device Information Report) ..................................... G1 Appendix H List of Exclusionary Drugs .............................................................................. H1 Appendix I Seizures ..........................................................................................................

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