5 Department of Psychiatry, Chonnam University Medical School, Kwangju, 6 Department of Biostatistics, Yonsei University, College of Medicine, Seoul,

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1 KISEP Original Articles 우울장애환자에서 Nefazodone의항우울효과, 항불안효과및수면 성기능 삶의질등에미치는영향에관한다기관연구 민성길 1 강병조 2 정인과 3 조맹제 4 윤진상 5 김동기 6 강민희 7 김도관 8 김명정 9 김석현 10 김용구 11 김정기 12 박민철 13 방계원 14 손봉기 15 신지용 16 오강섭 17 윤보현 18 이경규 19 정상근 20 정영기 21 정인원 22 정희연 23 제영묘 24 지익성 25 최병무 26 한선호 27 한오수 28 ABSTRACT A Multicenter Study on Effects of NefazodoneSerzone TM on Depression, Anxiety, Sleep, Sexual Functions, and Quality of Life in Patients with Depression Sung Kil Min, MD, PhD, 1 Byung Jo Kang, MD, PhD, 2 In Kwa Jung, MD, PhD, 3 Maeng Je Cho, MD, PhD, 4 Jin Sang Yoon, MD, PhD, 5 Dong Kee Kim, PhD, 6 Min Hee Kang, MD, PhD, 7 Doh Kwan Kim, MD, PhD, 8 Myung Jung Kim, MD, PhD, 9 Suk Hyung Kim, MD, PhD, 10 Yong Ku Kim, MD, PhD, 11 Jung Ki Kim, MD, PhD, 12 Min Cheol Park, MD, PhD, 13 Gae Won Bang, MD, PhD, 14 Bong Ki Sohn, MD, PhD, 15 Ji Yong Shin, MD, PhD, 16 Kang Seob Oh, MD, PhD, 17 Bo Hyun Yoon, MD, PhD, 18 Kyung Kyu Lee, MD, PhD, 19 Sang Keun Chung, MD, PhD, 20 Young Ki Jung, MD, PhD, 21 In Won Jung, MD, PhD, 22 Hee Yeon Jung, MD, PhD, 23 Young Moe Je, MD, PhD, 24 Ik Seung Chee, MD, PhD, 25 Byung Moo Choi, MD, PhD, 26 Sun Ho Han, MD, PhD 27 and Oh Su Han, MD, PhD 28 1 Department of Psychiatry, Yonsei University, College of Medicine, Seoul, 2 Department of Psychiatry, Kyungpook University College of Medicine, Daegu, 3 Department of Psychiatry, Korea University, College of Medicine, Seoul, 4 Department of Psychiatry, Seoul National University, College of Medicine, Seoul, 211

2 5 Department of Psychiatry, Chonnam University Medical School, Kwangju, 6 Department of Biostatistics, Yonsei University, College of Medicine, Seoul, 7 Department of Psychiatry, Inha University, College of Medicine, Inchon, 8 Department of Psychiatry, Samsung Seoul Hospital, Sungkyunkwan University, College of Medicine, Seoul, 9 Department of Psychiatry, Pusan University, College of Medicine, Pusan, 10 Department of Psychiatry, Guri Hospital, Hanyang University, College of Medicine, Guri, 11 Department of Psychiatry, Ahnsan Hospital, Korea University, College of Medicine, Ahnsan, 12 Maryknoll Hospital, Pusan, 13 Department of Psychiatry, Wonkwang University, College of Medicine, Iri, 14 St. John of God Hospital, Kwangju, 15 Department of Psychiatry, Choonchun Sungsim Hospital, Hallym University, College of Medicine, Choonchun, 16 Department of Psychiatry, Kangdong Sungsim Hospital, Hallym University, College of Medicine, Seoul, 17 Department of Psychiatry, Kangbuk Samsung Hospital, Sungkyunkwan University, School of Medicine, Seoul, 18 Naju Psychiatry Hospital, Naju, 19 Department of Psychiatry, Dankook University, College of Medicine, Chonahan, 20 Department of Psychiatry, Chonbuk National University Medical School, Chonju, 21 Department of Psychiatry, Ajou University, College of Medicine, Soowon, 22 Department of Psychiatry, Chungbuk University, College of Medicine, Chungju, 23 Department of Psychiatry, Chonahn Hospital, Soonchunhyang University, College of Medicine, Chonahn, 24 Chwachon Bongseng Hospital, Pusan, 25 Department of Psychiatry, Chungnam University, College of Medicine, Kwangju, 26 Department of Psychiatry, Donga University, College of Medicine, Pusan, 27 Department of Psychiatry, Soonchunhyang University, College of Medicine, Seoul, 28 Department of Psychiatry, Seoul Chungang Hospital, University of Ulsan, College of Medicine, Asan Medical Center, Seoul, Korea ObjectiveThe aim of this study is to determine effects of nefazodone on depression, anxiety, sleep and sexual function in depressive patients. Subjects and MethodsThis is an open, non-comparative, multi-center study. Antidepressant and other clinical effects of nefazodone were evaluated in 230 patients of 26 centers, aged 14 years or more, who met DSM-IV criteria to major depressive disorder or dysthymic disorder and didn t have other psychiatric disorders and were physically healthy. The clinical efficacy was assessed at week 1, 2, 4 and 8 using Clinical Global Improvement CGI, Hamilton Depression Scale HAM-D, Beck Depression Inventory BDI, State and Trait Anxiety Inventory-State Anxiety STAI-SA. Other clinical effects were assessed with Weekly Sleep Questionnaire, Sexual Functioning Questionnaire and GHQ-QOL-12, a scale for quality of life. Adverse drug reactions were checked with a questionnaire. Post-treatment effects of drug were compared with pre-treatment baseline condition. ResultsThe response rates by Clincal Grobal Improvement and HAM-D after 8 weeks treatment were 62.4% and 75.2% respectively. Comparing to baseline, nefazodone was proved to have significantly higher antidepressant and antianxiety effects in depressive patients and it improved also sleep, sexual functions and quality of life. Both patients and physicians satisfied with the effects of drug. Adverse drug reactions were a few and not serious, and most of them disappeared as treatment continued. ConclusionThese results suggest that not only nefazodone has antidepressant effects and antianxiety effects, but also it improves sleep disturbance, sexual dysfunction and the quality of life in depressive patients. Adverse drug reactions were a few and not serious. Korean J Psychopharmacol 2001;123: KEY WORDSNefazodone Antidepressant effect Anxiety Sleep disturbance Sexual dysfunction. 서론 212 Korean J Psychopharmacol 2001;123:

3 1. 연구대상 연구대상및방법 2. 약물투여 213

4 3. 임상효과및평가 1) 항우울효과 2) 불안증상, 수면, 성기능및삶의질에미치는영향 4. 안전성 5. 통계처리 1) 유효성분석 214 Korean J Psychopharmacol 2001;123:

5 2) 안전성분석 1. 연구대상환자 결 과 2. 항우울효과 215

6 Table 1. Patients rated as much improved in Clinical Global Improvement CGI and patients under 10 point in Hamilton Depression Scale HAM-D at 2 weeks, 4 weeks, and 8 weeks treatment period with nefazodone Week Clinical Global Improvement number of patients* % HAM-D number of patients % Week 2 59/ % 57/ % Week 4 90/ % 106/ % Week 8 103/ % 124/ % *responder/total 3. 항불안효과 4. 수면에미치는영향 5. 병용약제인진정수면제가항불안효과및수면에미치는영향 216 Korean J Psychopharmacol 2001;123:

7 6. 성기능에미치는영향 Table 2. Changes in depression, anxiety, sleep, sexual function, and quality of life in depressive patients with nefazodone treatment* Variable** Baseline Week of study week 1 week 2 week 4 week 8 HAM-D 1) N230 N199 N188 N BDI 1) N208 N179 N168 N STAI-SA 1) N208 N188 N179 N168 N HAM-D N230 N199 N188 N ) Weekly Sleep Q 1) N207 N189 N180 N168 N HAM-D 456 1) N230 N199 N188 N Weekly Sleep Q 2) N207 N189 N180 N168 N Weekly Sleep Q 3) N207 N189 N180 N168 N Sexual Functioning Q N179 N GHQ-QOL-12 N206 N *Values represent MeanSD **HAM-DHamilton Depression Scale, BDIBeck Depression Inventory, STAI-SASpielberger Trait Anxiety Inventory, HAM-D 91011Items 9, 10, 11 of HAM-D, Weekly Sleep QWeekly Sleep Questionnaire, HAM-D 456 Items 4, 5, 6 of HAM-D, Weekly Sleep Q 15Items 1, 2, 3, 4, 5 of Weekly Sleep Questionnaire, Weekly Sleep Q 6 7Items 6, 7 of Weekly Sleep Questionnaire, Sexual Functioning QSexual Functioning Questionnaire, GHQ- QOL-1212 items for quality of life in General Health Questionnaire The values are significantly different compared to baseline p The values are significantly different compared to baseline p Significant difference p between week 2 & 4, 2 & 8 and 4 & 8 2 Significant difference p0.009 between week 4 & 8, Significant difference p between week 2 & 1, 4 & 1, 8 & 1, 2 & 4, 2 & 8 and 4 & 8 3 Significant difference p0.01 between week 4 & 1, 8 & 1, 8 & 2 and 8 & 4, No significant difference p0.05 between week 2 & 1 and 2 & 4 217

8 Table 3. Post-treatment satisfaction with nefazodone Post-treatment satisfaction 7. 삶의질에미치는영향 Patient N % Investigator N % Very much dissatisfied Very dissatisfied Dissatisfied Neither dissatisfied nor satisfied Satisfied Very satisfied Very much satisfied 환자및의사만족도 9. 이상반응 고찰 218 Korean J Psychopharmacol 2001;123:

9 219

10 요약 목적 : 방법 : 결과 : 결론 : 중심단어 참고문헌 1) Robins LN, Heizer JE, Weissman MM, Burke JD Jr, Orvaschel H, Gruenberq E, et al. Life-time prevalence of specific psychiatric disorders in three sites. Arch Gen Psychiatry 1984; 41:949. 2) Regier DA, Boyd JH, Burke JD, Rae DS, Myers JK, Kromer M, et al. One month prevalence of mental disorders in the United State. Arch Gen Psychiatry 1988;45: ) Broadhead EW, Blazer DG, George LK, Tse CK. Depression disability days and days lost from work in a prospective epidemiologic survey. JAMA 1990;264: ) Wells KB, Stewart A, Hays RD, Burnam MA, Roqers W, Damiels M, et al. The functioning and well-being of depressed patients results from the medical outcomes study. JAMA 1989; 262: ) Revicki D, Turner R, Brown R, Martindale JJ. Reliability and Validity of a health-related quality of life battery for evaluating outpatient antidepressant treatment. Quality of Life Research 1992;1: ) Johnson J, Weissman MN, Klerman GL. Service, utilization and social morbidity associated with depressive symptoms in the community. JAMA 1992;267: ) Monkotoff K, Bergman E, Berk A. Hopelessness, depression and attempted suicide. Am J Psychiatry 1973;139: ) Kent JM, Sna RI. NaSSAs and NaRIs; New agents for treatment of depression. Lancet 2000;355: ) Cook MD, Coner J. Retrospective review of hypnotic use in combination with fluoxetine and sertraline. Clin Drug Invest 1995;9(4): ) Lonnqvist J, Sintonen H, Syvalahti E, Appelberq B, Koskinen T, Mannikko T, et al. Antidepressant efficacy and quality of life in depression: A double blind study with moclobemide and fluoxetine. Acta Psychiatr Scand 1994;89: ) Fontaine R, Ontiverous E, Elie R, et al. A double-blind comparison of nefazodone, imipramine, and placebo in major depression. J Clin Psychiatry 1994;55: ) Mendels J, Reimher F, Marcus RN, Roberts DL, Francis RJ, Anton SF. A double blind, placebo-controlled trial of two dose ranges of nefazodone in the treatment of depressed outpatients. J Clin Psychiatry 1995;56(suppl 6): ) Rickels K, Schweizer E, Clary C, Fox I, Weise C. Nefazodone and imipramine in major depression: A placebo-controlled trial. Br J Psychiatry 1994;164: Korean J Psychopharmacol 2001;123:

11 14) Cohn CK, Robinson DS, Roberts DL, Schwiderski UE, O Brien K, Ieni JR. Responders to antidepressants drug treatment: A study comparing nefazodone, imipramine, and placebo in patients with major depression. J Clin Psychiatry 1996;57(supple 2): ) Feigner JP, Pambakian R, Fowler RC, Boyer WF, D Amico MF. A comparison of nefazodone, imipramine, and placebo in patients with moderate to severe depression. Psychopharm Bull 1989;25: ) Baldwin DS, Hawley CJ, Abed RT, Maiagakis BD, Cox J, Buckingham SA, et al. A multicenter double-blind comparison of nefazodone and paroxetine in the treatment of outpatients with moderate to severe depression. J Clin Psychopharmacol 1996;57(suppl 2): ) Feiger A, Klev A, Shrivastava RK, Wisselink PG, Wilcox CS. Nefazodone versus sertraline in outpatients with major depression: Focus on efficacy, tolerability and effects on sexual function and satisfaction. J Clin Psychiatry 1996;57(suppl 2): ) Gillin JC, Rapaport M, Erman MK, Winokur A, Albala BJ. A comparison of nefazodone and fluoxetine on mood and on objective, subjective, and clinician-rated measures of sleep in depressed patients: A double-blind, 8-week clinical trial. J Clin Psychiatry 1997;58: ) Ansseau M, Darimont P, Lecoq A, De Nayer A, Evrard JL, Kremer P, et al. Controlled comparisone of nefazodone and amitriptyline in major depressive inpatients. Psychopharmacology(Berl) 1994;115: ) Rickels K, Robinson DS, Schweizer E, Marcus RN, Roberts DL. Nefazodone aspects of efficacy. J Clin Psychiatry 1995;56(suppl 6) : ) Feighner J, Targum SD, Bennett ME, Roberts DL, Kensler TT, D Amico MF, et al. A double blind, placebo-controlled trial of nefazodone in the treatment of patients hospitalized for major depression. J Clin Psychiatry 1998;59: ) Anton SF, Rhobinson DS, Roberts DL, Kensler TT, English PA, Archibald DG. Long term treatment of depression with nefazodone. Psychopharmacol Bull 1994;30: ) Montgomery SA. Efficacy of nefazodone in the treatment of depression. J Psychopharmacol 1996;10(suppl 1): ) Feiger AD, Bielski RJ, Bremner J, Heiser JF, Trivedi M, Wilcox CS, et al. Double-blind, placebo-substitution study of nefazodone in the prevention of release during continuation treatment of outpatinets with major depression. Int Clin Psychopharmacol 1999;14: ) American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4 th edition, American psychiatric Association, Washington DC; ) Hamilton M. A rating scale for depression. J Neuro Neurosurg Psychiatry 1960;23: ) 김광일. 우울증의증상학적연구. Hamilton 우울증측정표의적응을위한연구. 신경정신의학 1977;16: ) 한홍무 염태호 신영우 윤도순 정근재. Beck Depression Inventory 의한국어판표준화연구정상집단을중심으로 (1). 신경정신의학 1986;25: ) 김정택. 특성불안과사회성과의관계 Spielberger 의 ST- AI 를중심으로 ( 석사학위논문 ), 고려대학교대학원 ; ) Goldberg DP, Hillier VF. A scaled version of the General Health Questionnaire. Psychol Med 1979;99: ) Goldberg DP. Manual of the General Health Questionnaire. NFER Publishing, Windsor, England; ) Feigner J. A double blind, placebo-controlled trial of Nefazodone in the treatment of patients hospitalized for major depression. J Clin Psychiatry 1998;59:

012임수진

012임수진 Received : 2012. 11. 27 Reviewed : 2012. 12. 10 Accepted : 2012. 12. 12 A Clinical Study on Effect of Electro-acupuncture Treatment for Low Back Pain and Radicular Pain in Patients Diagnosed with Lumbar