| |
Effectiveness of lithium in subjects with treatment-resistant depression and suicide risk: results and lessons of an underpowered randomised clinical trial
- 作者:Francesca Girlanda (18)
Andrea Cipriani (18) (19) Emilia Agrimi (20) Maria Grazia Appino (21) Andrea Barichello (18) Rossella Beneduce (22) Irene Bighelli (18) Giulia Bisoffi (23) Alfredo Bisogno (24) Paola Bortolaso (25) Marianna Boso (26) Carmela Calandra (27) Liliana Cascone (24) Mariasole Castellazzi (18) Caterina Corbascio (28) Vincenzo Fricchione Parise (29) Francesco Gardellin (30) Daniele Gennaro (31) Batul Hanife (18) Camilla Lintas (32) Marina Lorusso (33) Antonina Luca (34) Maria Luca (27) Chiara Luchetta (35) Claudio Lucii (36) Francesca Maio (28) Alessandra Marsilio (37) Chiara Mattei (38) Daniele Moretti (21) Michela Nos猫 (18) Guglielmo Occhionero (39) Duccio Papanti (35) Damiano Pecile (18) Mauro Percudani (40) Davide Prestia (38) Marianna Purgato (18) Francesco Restaino (40) Salvatore Romeo (27) Tiziana Sciarma (41) Stefania Strizzolo (30) Stefania Tamborini (20) Orlando Todarello (33) Fiorella Tozzi (36) Simona Ziero (39) Spyridon Zotos (42) Corrado Barbui (18)
18. Dipartimento di Sanit脿 Pubblica e Medicina di Comunit脿 ; Sezione di Psichiatria ; Universit脿 di Verona ; Verona ; Italy 19. Department of Psychiatry ; Warneford Hospital ; Oxford ; UK 20. Servizio Psichiatrico di Diagnosi e Cura ; Istituti Ospitalieri di Cremona ; Cremona ; Italy 21. Dipartimento di Salute Mentale ; Centro di Salute Mentale di Finale Ligure ; Asl n掳2 ; Savona ; Italy 22. IRCCS 鈥淐entro San Giovanni di Dio鈥?FBF ; Brescia ; Italy 23. Ufficio Supporto alla Ricerca e Biostatistica ; Azienda Ospedaliera Universitaria Integrata di Verona ; Verona ; Italy 24. Dipartimento di Salute Mentale ; UO Salute Mentale Cava de鈥橳irreni - Costa d鈥橝malfi ; ASL ; Salerno ; Italy 25. Servizio Psichiatrico di Diagnosi e Cura Cittiglio ; Psichiatria del presidio del Verbano ; Ospedale di Circolo e Fondazione Macchi ; Varese ; Italy 26. Azienda Ospedaliera di Pavia e Dipartimento di Neuroscienze ; Centro Psico-Sociale di Pavia ; Sezione di Psichiatra ; Universit脿 di Pavia ; Pavia ; Italy 27. Dipartimento di Specialit脿 Medico-Chirurgiche ; Sezione di Psichiatria ; Azienda Ospedaliero Universitaria ; 鈥淧oliclinico-Vittorio Emanuele鈥? Catania ; Italy 28. Dipartimento di Salute Mentale ; Asl AT ; Asti ; Italy 29. Asl Avellino (Regione Campania) ; U.O.C. di Salute Mentale di Avellino ; Avellino ; Italy 30. Dipartimento di Salute Mentale ; Ulss 6 ; Vicenza ; Italy 31. Azienda Ospedaliera SS Antonio e Biagio ; Alessandria ; Italy 32. 1掳 Servizio autonomo di Psichiatria ; Ulss 20 ; Verona ; Italy 33. Universit脿 鈥淎ldo Moro鈥?Bari ; Bari ; Italy 34. Dipartimento GF Ingrassia ; Sezione di Neuroscienze ; Azienda Ospedaliero Universitaria 鈥淧oliclinico-Vittorio Emanuele鈥?Catania ; Catania ; Italy 35. Dipartimento di Salute Mentale ; Azienda per i Servizi Sanitari n掳1 Triestina ; Trieste ; Regione FVG ; Italy 36. Dipartimento Interaziendale di Salute Mentale e Dipendenze di Siena ; Siena ; Italy 37. Dipartimento di Salute Mentale ; Ulss 18 ; Rovigo ; Italy 38. Clinica Psichiatrica dell鈥橴niversit脿 di Genova ; Genova ; Italy 39. S.O.C Psichiatria Asti Centro-Nord ; Asl AT ; Asti ; Italy 40. Unit脿 Operativa di Psichiatria n掳 62 ; Bollate ; DSM A.O. 鈥淕. Salvini鈥? Garbagnate Milanese ; Italy 41. Dipartimento di Medicina Sezione di Psichiatria Psicologia Clinica e Riabilitazione Psichiatrica ; Universit脿 di Perugia ; Perugia ; Italy 42. Azienda Uls di Ferrara ; Ferrara ; Italy
- 关键词:Randomised controlled trial ; Lithium ; Suicide ; Deliberate self harm ; Mortality ; Treatment resistant depression
- 刊名:BMC Research Notes
- 出版年:2014
- 出版时间:December 2014
- 年:2014
- 卷:7
- 期:1
- 全文大小:374 KB
- 参考文献:1. Hawton, K, Arensman, E, Townsend, E, Bremner, S, Feldman, E, Goldney, R, Gunnell, D, Hazell, P, van Heeringen, K, House, A, Owens, D, Sakinofsky, I, Tr盲skman-Bendz, L (1998) Deliberate self harm: systematic review of efficacy of psychosocial and pharmacological treatments in preventing repetition. BMJ 317: pp. 441-447 lass="external" href="http://dx.doi.org/10.1136/bmj.317.7156.441" target="_blank" title="It opens in new window">CrossRef
2. Hawton, K, Townsend, E, Arensman, E, Gunnell, D, Hazell, P, House, A, van Heeringen, K (2000) Psychosocial versus pharmacological treatments for deliberate self harm. Cochrane Database Syst Rev. pp. CD001764 3. Cipriani, A, Pretty, H, Hawton, K, Geddes, JR (2005) Lithium in the prevention of suicidal behavior and all-cause mortality in patients with mood disorders: a systematic review of randomized trials. Am J Psychiatry 162: pp. 1805-1819 lass="external" href="http://dx.doi.org/10.1176/appi.ajp.162.10.1805" target="_blank" title="It opens in new window">CrossRef 4. Cipriani, A, Hawton, K, Stockton, S, Geddes, JR (2013) Lithium in the prevention of suicide in mood disorders: updated systematic review and meta-analysis. BMJ 346: pp. f3646 lass="external" href="http://dx.doi.org/10.1136/bmj.f3646" target="_blank" title="It opens in new window">CrossRef 5. Cipriani, A, Girlanda, F, Agrimi, E, Barichello, A, Beneduce, R, Bighelli, I, Bisoffi, G, Bisogno, A, Bortolaso, P, Boso, M, Calandra, C, Cascone, L, Corbascio, C, Parise, VF, Gardellin, F, Gennaro, D, Hanife, B, Lintas, C, Lorusso, M, Luchetta, C, Lucii, C, Cernuto, F, Tozzi, F, Marsilio, A, Maio, F, Mattei, C, Moretti, D, Appino, MG, Nos猫, M, Occhionero, G (2013) Effectiveness of lithium in subjects with treatment-resistant depression and suicide risk: a protocol for a randomised, independent, pragmatic, multicentre, parallel-group, superiority clinical trial. BMC Psychiatry 13: pp. 212 lass="external" href="http://dx.doi.org/10.1186/1471-244X-13-212" target="_blank" title="It opens in new window">CrossRef 6. Moher, D, Schulz, KF, Altman, DG (2001) The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet 357: pp. 1191-1194 lass="external" href="http://dx.doi.org/10.1016/S0140-6736(00)04337-3" target="_blank" title="It opens in new window">CrossRef 7. Zwarenstein, M, Treweek, S, Gagnier, JJ, Altman, DG, Tunis, S, Haynes, B, Oxman, AD, Moher, D (2008) Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 337: pp. a2390 lass="external" href="http://dx.doi.org/10.1136/bmj.a2390" target="_blank" title="It opens in new window">CrossRef 8. Sheehan, DV, Lecrubier, Y, Sheehan, KH, Amorim, P, Janavs, J, Weiller, E, Hergueta, T, Baker, R, Dunbar, GC (1998) The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry 59: pp. 22-33 9. Rush, AJ, Trivedi, MH, Ibrahim, HM, Carmody, TJ, Arnow, B, Klein, DN, Markowitz, JC, Ninan, PT, Kornstein, S, Manber, R, Thase, ME, Kocsis, JH, Keller, MB (2003) The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry 54: pp. 573-583 lass="external" href="http://dx.doi.org/10.1016/S0006-3223(02)01866-8" target="_blank" title="It opens in new window">CrossRef 10. Rush, AJ, Trivedi, MH, Wisniewski, SR, Stewart, JW, Nierenberg, AA, Thase, ME, Ritz, L, Biggs, MM, Warden, D, Luther, JF, Shores-Wilson, K, Niederehe, G, Fava, M (2006) Bupropion-SR, sertraline, or venlafaxine-XR after failure of SSRIs for depression. N Engl J Med 354: pp. 1231-1242 lass="external" href="http://dx.doi.org/10.1056/NEJMoa052963" target="_blank" title="It opens in new window">CrossRef 11. Guzzetta, F, Tondo, L, Centorrino, F, Baldessarini, RJ (2007) Lithium treatment reduces suicide risk in recurrent major depressive disorder. J Clin Psychiatry 68: pp. 380-383 lass="external" href="http://dx.doi.org/10.4088/JCP.v68n0304" target="_blank" title="It opens in new window">CrossRef 12. Barbui, C, Accordini, S, Nose, M, Stroup, S, Purgato, M, Girlanda, F, Esposito, E, Veronese, A, Tansella, M, Cipriani, A (2011) Aripiprazole versus haloperidol in combination with clozapine for treatment-resistant schizophrenia in routine clinical care: a randomized, controlled trial. J Clin Psychopharmacol 31: pp. 266-273 lass="external" href="http://dx.doi.org/10.1097/JCP.0b013e318219cba3" target="_blank" title="It opens in new window">CrossRef 13. Cipriani, A, Accordini, S, Nose, M, Purgato, M, Girlanda, F, Tansella, M, Barbui, C (2013) Aripiprazole versus haloperidol in combination with clozapine for treatment-resistant schizophrenia: a 12-month, randomized, naturalistic trial. J Clin Psychopharmacol 33: pp. 533-537 lass="external" href="http://dx.doi.org/10.1097/JCP.0b013e318296884f" target="_blank" title="It opens in new window">CrossRef 14. Ghaemi, SN, Dalley, S (2014) The bipolar spectrum: conceptions and misconceptions. Aust N Z J Psychiatry 48: pp. 314-324 lass="external" href="http://dx.doi.org/10.1177/0004867413504830" target="_blank" title="It opens in new window">CrossRef 15. Ivkovic, A, Stern, TA (2014) Lithium-induced neurotoxicity: clinical presentations, pathophysiology, and treatment. Psychosomatics 55: pp. 296-302 lass="external" href="http://dx.doi.org/10.1016/j.psym.2013.11.007" target="_blank" title="It opens in new window">CrossRef 16. McIntyre, RS, Filteau, MJ, Martin, L, Patry, S, Carvalho, A, Cha, DS, Barakat, M, Miguelez, M (2014) Treatment-resistant depression: definitions, review of the evidence, and algorithmic approach. J Affect Disord 156: pp. 1-7 lass="external" href="http://dx.doi.org/10.1016/j.jad.2013.10.043" target="_blank" title="It opens in new window">CrossRef 17. Spielmans, GI, Berman, MI, Linardatos, E, Rosenlicht, NZ, Perry, A, Tsai, AC (2013) Adjunctive atypical antipsychotic treatment for major depressive disorder: a meta-analysis of depression, quality of life, and safety outcomes. PLoS Med 10: pp. e1001403 lass="external" href="http://dx.doi.org/10.1371/journal.pmed.1001403" target="_blank" title="It opens in new window">CrossRef 18. Goldacre, B (2013) Are clinical trial data shared sufficiently today? No. BMJ 347: pp. f1880 lass="external" href="http://dx.doi.org/10.1136/bmj.f1880" target="_blank" title="It opens in new window">CrossRef
- 刊物主题:Biomedicine general; Medicine/Public Health, general; Life Sciences, general;
- 出版者:BioMed Central
- ISSN:1756-0500
文摘
Background As lithium treatment might be effective in reducing the risk of deliberate self-harm (DSH) in adult patients with unipolar affective disorders, we designed a pragmatic randomised trial to assess its efficacy in more than 200 patients with treatment-resistant depression. However, we randomised 56 patients only. The aim of this report is therefore twofold: first, to disseminate the results of this underpowered study which may be incorporated into future meta-analytical reviews; second, to analyse some critical aspects of the study which might explain failure to reach the target sample size. Methods We carried out a randomised, parallel group, assessor-blinded superiority clinical trial. Adults with a diagnosis of major depression, an episode of DSH in the previous 12 months and inadequate response to at least two antidepressants given sequentially at an adequate dose for an adequate time for the current depressive episode were allocated to add lithium to usual care (intervention arm) versus usual care alone (control arm). Suicide completion and acts of DSH during the 12 months of follow-up constituted the composite primary outcome. Results Of 58 patients screened for inclusion, 29 were allocated to lithium plus usual care and 27 were assigned to usual care without lithium. Six patients in the lithium plus usual care group and seven in the usual care group committed acts of DSH during the follow-up phase. The survival probability did not differ between the two treatment arms (Chi2 = 0.17, p =0.676). With regard to changes in the severity of depressive symptomatology from baseline to endpoint, no significant differences were detected. Conclusions The present study failed to achieve the minimum sample size needed to detect a clinically meaningful difference between the two treatment arms. Consequently, the finding that lithium, in addition to usual care, did not exert a positive effect in terms of reduction of DSH after 12 months of follow-up is likely due to the lack of sufficient statistical power to detect a difference, if a difference existed. The dissemination of the results of this underpowered study will inform future meta-analytical reviews on lithium and suicide-related outcomes. Trial registration ClinicalTrials.gov identifier: NCT00927550
| |
NGLC 2004-2010.National Geological Library of China All Rights Reserved.
Add:29 Xueyuan Rd,Haidian District,Beijing,PRC. Mail Add: 8324 mailbox 100083
For exchange or info please contact us via email.
| |