Effectiveness of lithium in subjects with treatment-resistant depression and suicide risk: results and lessons of an underpowered randomised clinical trial
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- 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
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- 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