DOCSLIB.ORG

Study Protocol CSP #556, “The Effectiveness Of

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
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 ..........................................................................................................
Load more

Recommended publications
  • Yeah. 'But It's Also Very Personal and Subconscious and I Guess If You
    EXHIBIT 135 WIT.900.020.0144 Yeah. 'But it's also very personal and subconscious and I guess if you were my psychologist or something I would feel a little more uncomfortable with you seeing it, but I don't know if you can see all the stiif.f. I mean because it's very personal. 3rd interview) Some found the experience very exciting: It was really cool because I guess when you first gave it to me I was so excited I'm like "Oh my God, what am I going to take photos op" I was just like trying to like run around and find all these ideas. But then I'm like "No, wait. Get over the excitement and start like figuring out what to do". So, yeah, it was Jim. ; 2nd interview) found it therapeutic and a most useful tool to express emotion and feel in control: It was actually quite good, because I could express a lot ofthings that I couldn't express verbally. Such emotions that I have no control over and kind of taking photos of them, that's kind of like taking control of them, which is good - feeling in control. And it calms me down in a sense. ; 2nd interview) For two of the adolescents, their photos revealed how useful visual material can be in sharing their stories: It's just basically like I can't find the right words to talk about my problems. And as you can see there's spaces in there, and that... Yeah. And I just - it's like for when I'm talking to someone I feel like I can't find the right words to express my feelings.
    [Show full text]
  • Manifestations of Interactivity in Music and Their Commercial Potential in the Music Industry’S Contemporary Political Economy
    Manifestations of interactivity in music and their commercial potential in the music industry’s contemporary political economy by George Morahan A research paper submitted to the University of Dublin, in partial fulfillment of the requirements for the degree of Master of Science Interactive Digital Media 2015 Declaration I declare that the work in this research paper is, except where otherwise stated, entirely my own work and has not been submitted as an exercise for a degree at this or any other university. signed: ________________________________ George Morahan date: 15th May 2015 1 Permission to lend and/or copy I agree that Trinity College Dublin may lend or copy this research paper upon request. signed: ________________________________ George Morahan 2 Acknowledgements I would like to thank my supervisor, Marguerite Barry, for her encouragement and firm guidance. I would also like to thanks the rest of the IDM 2014-15 class for the mania we have shared as well as my family for their understanding and support in the face of utter neglect these past eight months. For Lorraine and Stevie. 3 Table of contents 1. Introduction 6 1.1. Definitions of interactivity 6 1.2. Concept definition of interactive music video 7 1.3. Interactive music software within the purview of this research paper 8 1.4. Research objectives 9 2. The literature on the political economy of the music industry 10 2.1. Record industry as music industry 10 2.2. Music networks and diversification into auxiliary industries 13 ​ 2.3. Imagining the future music industry 16 ​ 2.4. Artist vs. Industry attitudes 17 ​ 2.5.
    [Show full text]
  • Butterfly Lovers V1.0
    Butterfly Lovers v1.0 Butterfly Lovers: Leung Shanpak and Chuk Yingtoi 梁祝恨史 An English Translation of Fong Yim Fun’s Performance Script 芳艷芬演出本 1955 Scripted by PAN Yi Fan 潘一帆編劇 * This Translation (Version 1.0) by NG Wing Chung 伍榮仲 (History, University of Texas at San Antonio) © 2012 * Major Plays of Hong Kong Cantonese Opera: A Translation Project 香港粵劇經典劇目翻譯計劃 Kwan Fong Cultural Research and Development Programme Lingnan University 群芳文化研究及發展部 嶺南大學 Funded by the Cantonese Opera Development Fund 粵劇發展基金資助 1 Butterfly Lovers v1.0 Butterfly Lovers: Leung Shanpak and Chuk Yingtoi An English Translation of Fong Yim Fun’s Performance Script 1955 Scripted by PAN Yi Fan This Translation (Version 1.0) by NG Wing Chung This work is licensed under a Creative Commons Attribution-NonCommercial 3.0 Unported License. You are free: to Share — to copy, distribute and transmit the work to Remix — to adapt the work Under the following conditions: Attribution — You must attribute the work in the manner specified by the author or licensor (but not in any way that suggests that they endorse you or your use of the work). Noncommercial — You may not use this work for commercial purposes. This work is also released under this special condition: You may make commercial use of the work only in the circumstance of adapting the work for use as English surtitles/supertitles in Cantonese opera performances. http://creativecommons.org/licenses/by-nc/3.0/ http://creativecommons.org/licenses/by-nc-sa/3.0/hk/legalcode 2 Butterfly Lovers v1.0 Butterfly Lovers: Leung Shanpak
    [Show full text]
  • Quadrophonic News Issue 7
    Major Album Releases In The Fourth Quarter, 2013: Reflektor -Arcade Fire October 29th, 2013 Artpop -Lady Gaga November 11th, 2013 Live on the BBC Vol. 2 -The Beatles November 11th, 2013 •New -Paul McCartney •Beyoncé -Beyoncé •Matangl -M.I.A. •Because The Internet QUADROPHONIC NEWS •Shangri La -Jake Bugg -Childish Gambino Quadrophonic News December 2013 Issue 7 Female Artists: A Reflection In This Month’s Issue: There's a lot to be said for any vocalist with a truly amazing • Album Reviews: Reflektor, Yeezus, Centipede Hz, voice, but there's undeniably something special about a woman with a MMLP2, Live Through This, Bleach, Night Time, powerful voice and monumental skill in writing. So in this article I hope My Time to pay tribute to some of the best female vocalists/song writers out there. It's a big category so, unfortunately I won't be able to get to every one • Insight On Famous Female Artists I’d like to, but I hope to cover three of my favorites. • December/January Music Event Calendar First up is Patty Griffin. Patty is a powerful song writer from Old Town, Maine. her musical style is hard to pin down but it lands somewhere between folk and rock. Her voice is one of incredible range, Arcade Fire’s Reflektor Review her voice can convey every emotion you can imagine, softly or loudly, Achtung Baby. OK Computer. Sound of Silver. sweetly or harshly, and this amazing voice is accompanied by her Elephant. All of these albums are special. You remember indomitable talent for song writing.
    [Show full text]
  • APPENDIX D the Interview Transcriptions Olivia
    The Experience of Coming Out 207 APPENDIX D The Interview Transcriptions Olivia [1] Can you tell me when the possibility first occurred to you that you were sexually attracted to women? I think I was about…23. I was asexual…for a long time. Through undergrad and the first part of grad school. A woman approached me. Many women would approach me. And um…a lot of people assumed I was gay before I even acknowledged or even dealt with it. Once I left my father’s house, I just was not sexual. [2] So you were 23 years old, and then what happened? You were out of the house. I was out of the house. I was in graduate school already. Her name was Sara Lincoln. She befriended me. There were a couple of women but I didn’t really know what the response was. To give you some background on that, my mother left my father when I was ten. Okay? Um, So he…there was four of us, and he raised us. I took her place in the household. Okay, um …[pause] and I was a chubby child. I was bulimic. And as a young adult, I didn’t want the weight. I didn’t like um “you have a fat ass” type of thing. So even now my sister goes through this thing about how I eat. Um…If I gain, you know, too much weight I [shifted around on the couch with a deep breath] get real paranoid-hysterical? Because I don’t like the attraction of the body.
    [Show full text]
  • Calling out Culture Vultures: Nonwhite Interpretations of Cultural Appropriation in the Era of Colorblindness
    Calling Out Culture Vultures: Nonwhite Interpretations of Cultural Appropriation in the Era of Colorblindness A Dissertation Submitted to the Graduate School at the University of Cincinnati in partial fulfillment of the requirements for the degree of Doctor of Philosophy (Ph.D.) in the Department of Sociology of the College of Arts and Sciences by Aaryn L. Green B.A., University of Cincinnati, 2009 M.A. University of Cincinnati, 2012 Dissertation Chair: Erynn Casanova Committee Members: Jennifer Malat Annulla Linders June 2018 Abstract Colorblind theory argues that racism has not subsided but has taken on a new form which appears nonracial and is hard to detect. Music videos are one form of popular culture that utilizes cross-racial or cultural images which appear to be racially inclusive, but when closely analyzed are firmly rooted in traditional stereotypes and take cultural expressions out of their proper sociohistorical contexts. This process is called cultural appropriation. Too often, researchers have determined what modes of appropriation are or are not harmful to various groups without any input from those groups. In this study I provide a space for racial groups whose creations or expressions are habitually appropriated to tell us which modes of appropriation they consider to be harmful. I use a dual qualitative method—music video content analysis and focus group interviews with 61 participants—to investigate representations of nonwhite cultures and how audiences of color interpret the use of their cultures within popular music
    [Show full text]
  • Download PDF (10.6
    BARBARA PHILPOT. & Sittbg at M&nmxz &rib Mauls. (1727 to 1737.) BY THE HON. LEWIS WINGFIELD, AUTHOR OF ' 'LADY GRIZEL,' ABIGEI. ROWE,' 'IN HER MAJESTY'S KEEPING,' ETC. IN THREE VOLUMES. VOL. III. LONDON : RICHARD BENTLEY AND SON, ^ttblishcrs in ©rtonarn to Jfcr JFKajesia the (Qnetrt. 1885. [All Rights Reserved.] CONTENTS OF VOL. III. CHAPTER PAGE ' ' I. THE TABERNACLE OF SIN - - - I ' ' II. PARTNERSHIP - - - - "3° ' ' III. THE PILGRIM CALLS - - - 56 ' ' IV. CHECK TO YOUR KNIGHT - "85 - V. 'A NEW LIFE' - - - - 120 VI. 'JARS' ------ 141 - VII. THE PILGRIM CALLS AGAIN - - l8l - VIII. 'COUNTING THE CHICKENS' - - 2IO - - IX. 'THE PLOT RIPENS' - -225 ' ' X. THE QUEEN RETIRES - - - 254 XI. 'BAB THROWS THE GAUNTLET*- - - 272 ' ' XII. HONEST JACK'S LAST CARD - - 288 4 9 BARBARA PHILPOT. CHAPTER I. ' THE TABERNACLE OF SIN.' N how many ingenious ways may the human heart be wounded ! Philosophy, which bids us seek out and dwell upon the better side of things, cannot so plunge her children in wisdom-water but that a heel will be vulnerable to danger from poisoned arrows. The pilgrimage of a weak woman downhill is a lugubrious line for pen to trace. Yet, since we've looked on the bewitching Philpot when she fizzed across the firmament of Drury with fiery tail, 'tis only right to look upon her now—in guise of profit able lesson—deprived of tail, a mere expiring fire work. Again must we bend our steps to incongruous Southwark—not to behold our wayward Barbara in vol. in. 4° 2 BARBARA PHILPOT. rustling sacque and sumptuous jewelled earrings, swimming into the Bearpit, or commanding a beau contingent among the fair-booths, but crawling over London Bridge in company with Theo, who had deftly arranged the matter of her moving, in a musty hackney-coach floored with damp hay, past the pillory and cage, round the miry corner of Foul Lane, through Deadman's Place to the portals of the Clink Prison.
    [Show full text]
  • Tl Seniors Celebrate Last *100 Days' Before Graduation
    OP-ED M A&E P. 9 SPORTS P. 12 Going green to get green Super Bowl commerical favorites Record-breaking run Christina Hughes challenges students to reduce their energy Anthony Lauriello reviews notable commercials and the Senior Becky Wade breaks a Rice record in the 3,000 meter usage in order to save money in the Green Dorm Initiative. half-time show from Sunday's Super Bowl telecast. run during at the women's track meet at Notre Dame. thVOLUME XCVIIIe, ISSUE NO. Ric19 STUDENT-RUe N SINCE 1916 FRIDAY, FEBRUARY 10, 2012 Seniors celebrate last *100 Days' before graduation Clockwise from above: l) Hanszen College senior Sam Hile shows his excitement for the last 100 days before commencement. 2) Senior girls tire all smiles at the celebra- tion on Feb. 2.3) Students dance at Red Door and Wonder Bar for the "100 Days" event. BY ELLEN LIU asked to remain anonymous, was The witness said he attributed the none of her bones were broken. The Director Megan Peet, the staff liaison THRESHER EDITORIAL STAFF knocked down by the crowd while accident to poorly organized trans- injured student declined to comment. for 100 Days, said. This may include trying to get on an approaching bus portation and student intoxication. The witness said he believed that having RUPD at the loading zone or Around 800 people poured into and could not get up before the bus "They had buses for 50 people, the organizers should have asked more line-up areas for each bus. Red Door and Wonder Bar during 100 drove over her foot.
    [Show full text]
  • Master Georgie a Novel Beryl Bainbridge Carroll & Graf Publishers, Inc. New York
    Master Georgie a novel Beryl Bainbridge Carroll & Graf Publishers, Inc. New York Beryl Bainbridge is the distinguished author of The Birthday Boys and Every Man For Himself. She has four times been nominated for the Booker Prize, and twice won the Whitbread Prize for Fiction. She lives in London For Mike and Parvin Lawrence Plate 1. 1846 GIRL IN THE PRESENCE OF DEATH I was twelve years old the first time Master Georgie ordered me to stand stock still and not blink. My head was on a level with the pillow and he had me rest my hand on Mr Hardy’s shoulder; a finger-tip chill struck through the cloth of his white cotton shirt. It was a Saturday, the feast of the Assumption, and to stop my eyelids from fluttering I pretended God would strike me blind if I let them, which is why I ended up looking so startled. Mr Hardy didn’t have to be told to keep still because he was dead. I say I was twelve years old, but I can’t be sure. I don’t recollect a mother and never had a birthday until the Hardy family took me in. According to Master Georgie, I’d been found some nine years before, in a cellar in Seel Street, sat beside the body of a woman, whose throat had been nibbled by rats. I didn’t have a name, so they called me Myrtle, after the street where the orphanage stands. It was intended I should be placed there, and I would have been if the smallpox hadn’t broken out.
    [Show full text]
  • * * * * Fat Wreck Chords
    fanzine * webzine * Fat Wreck Chords * The Causey Way * The Gossip * Selby Tigers * Smogtown * Youth Brigade From the editors: You're probably wondering who the hell we are, right? Basically, a bunch of us used to write for a punk magazine called B-sides or something like that. Maybe Flipside? It was actually the longest continuously publishing punk rock magazine in America. It may still be. I can't say for sure. All I know PO Box 42124 from my personal experience is that I did an interview with Against All Authority sometime during the summer of 1999, and that interview is set to Los Angeles, CA 90042 run in the next issue. So if it does still come out, at least we know it's timely. www.razorcake.com Anyway, if you want to know more about Flipside and its possible demise, check out Todd's column. And now on to the things I do know about. I know Todd left Flipside and wanted to start a new magazine, so first he Email went to Tucson to meet with Skinny Dan and Katy. Together, the three of Sean <[email protected]> them came up with the name and the beginnings of a web zine. Shortly after Todd<[email protected]> that, Todd took a vacation to Florida to hang out with me and drink away his Rich Mackin <[email protected]> woes. While he was there, we started talking about the web zine and I said Nardwuar <[email protected]> something like, "What about poor fuckers like me who can only use the inter- Designated Dale<[email protected]> net in half hour intervals at the library?" Todd said something like, "You're Everyone else can be reached c/o Razorcake.
    [Show full text]
  • Actress-By-Anne-Enright
    ACTRESS A NOVEL Anne Enright ‘the more I applauded, the better, it seemed to me, did Berma act.’ In Search of Lost Time CONTENTS Chapter 1 Chapter 2 Chapter 3 Chapter 4 Chapter 5 Chapter 6 Chapter 7 Chapter 8 Chapter 9 Chapter 10 Chapter 11 Chapter 12 Chapter 13 Chapter 14 Chapter 15 Chapter 16 Chapter 17 Chapter 18 Chapter 19 Chapter 20 Chapter 21 Chapter 22 Chapter 23 Chapter 24 Chapter 25 Chapter 26 Acknowledgements PEOPLE ASK ME, ‘What was she like?’ and I try to figure out if they mean as a normal person: what was she like in her slippers, eating toast and marmalade, or what was she like as a mother, or what she was like as an actress – we did not use the word star. Mostly though, they mean what was she like before she went crazy, as though their own mother might turn overnight, like a bottle of milk left out of the fridge. Or they might, themselves, be secretly askew. Something happens as they talk to me. I am used to it now. It works in them slowly; a growing wonder, as though recognising an old flame after many years. ‘You have her eyes,’ they say. People loved her. Strangers, I mean. I saw them looking at her and nodding, though they failed to hear a single word she said. And, yes, I have her eyes. At least, I have the same colour eyes as my mother; a hazel that, in her case, people liked to call green. Indeed, whole paragraphs were penned about bog and field, when journalists looked into my mother’s eyes.
    [Show full text]
  • The Effects of Objectifying Hip-Hop Lyrics on Female Listeners" (2013)
    Macalester College DigitalCommons@Macalester College Psychology Honors Projects Psychology Department Spring 5-1-2013 The ffecE ts of Objectifying Hip-Hop Lyrics on Female Listeners Ellen S. Nikodym [email protected] Follow this and additional works at: http://digitalcommons.macalester.edu/psychology_honors Part of the Social Psychology Commons Recommended Citation Nikodym, Ellen S., "The Effects of Objectifying Hip-Hop Lyrics on Female Listeners" (2013). Psychology Honors Projects. Paper 31. http://digitalcommons.macalester.edu/psychology_honors/31 This Honors Project is brought to you for free and open access by the Psychology Department at DigitalCommons@Macalester College. It has been accepted for inclusion in Psychology Honors Projects by an authorized administrator of DigitalCommons@Macalester College. For more information, please contact [email protected]. Running head: EFFECTS OF OBJECTIFYING HIP HOP 1 The Effects of Objectifying Hip Hop Lyrics on Female Listeners Ellen Nikodym Macalester College EFFECTS OF OBJECTIFYING HIP HOP 2 Abstract Research has demonstrated support for objectification theory and has established that music affects listeners’ thoughts and behaviors, however, no research to date joins these two fields. The present study considers potential effects of objectifying hip hop songs on female listeners. Among African American participants, exposure to an objectifying song resulted in increased self-objectification. However, among White participants, exposure to an objectifying song produced no measurable difference in self-objectification. This finding along with interview data suggests that white women distance themselves from objectifying hip hop songs, preventing negative effects of such music. EFFECTS OF OBJECTIFYING HIP HOP 3 The Effects of Objectifying Hip-Hop Lyrics on Female Listeners Music is an important part of adolescents’ and young adults’ lives.
    [Show full text]