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

BMC Research Notes

Volumn 7, Issue 1, 2014, Pages

  Girlanda, Francesca ^a   Cipriani, Andrea ^a,b   Agrimi, Emilia ^c   Appino, Maria Grazia ^d   Barichello, Andrea ^a   Beneduce, Rossella ^e   Bighelli, Irene ^a   Bisoffi, Giulia ^f   Bisogno, Alfredo ^g   Bortolaso, Paola ^h   Boso, Marianna ⁱ   Calandra, Carmela ^j   Cascone, Liliana ^g   Castellazzi, Mariasole ^a   Corbascio, Caterina ^k   Parise, Vincenzo Fricchione ^l   Gardellin, Francesco ^m   Gennaro, Daniele ⁿ   Hanife, Batul ^a   Lintas, Camilla ^o   Lorusso, Marina ^p   Luca, Antonina ^j   Luca, Maria ^j   Luchetta, Chiara ^k   Lucii, Claudio ^q   Maio, Francesca ^k   Marsilio, Alessandra ^r   Mattei, Chiara ^s   Moretti, Daniele ^d   Nosè, Michela ^a   Occhionero, Guglielmo ^t   Papanti, Duccio ^k   Pecile, Damiano ^a   Percudani, Mauro ^u   Prestia, Davide ^s   Purgato, Marianna ^a   Restaino, Francesco ^u   Romeo, Salvatore ^j   Sciarma, Tiziana ^v   Strizzolo, Stefania ^m   Tamborini, Stefania ^c   Todarello, Orlando ^p   Tozzi, Fiorella ^q   Ziero, Simona ^t   Zotos, Spyridon ^w   Barbui, Corrado ^a   more..

^a UNIVERSITY OF VERONA   (Italy)

^b WARNEFORD HOSPITAL   (United Kingdom)

^c CREMONA HOSPITAL   (Italy)

^d Centro di Salute Mentale di Finale Ligure   (Italy)

^e IRCCS ISTITUTO CENTRO SAN GIOVANNI DI DIO FATEBENEFRATELLI   (Italy)

^f UNIVERSITY HOSPITAL OF VERONA   (Italy)

^g ASL   (Italy)

^h OSPEDALE DI CIRCOLO   (Italy)

ⁱ UNIVERSITY OF PAVIA   (Italy)

^j UNIVERSITY OF CATANIA   (Italy)

^k Dipartimento di Salute Mentale   (Italy)

^l ASL Avellino 'A Landolfi Hospital'   (Italy)

^m Dipartimento di Salute Mentale   (Italy)

ⁿ C Arrigo Children's Hospital   (Italy)

^o 1o Servizio Autonomo di Psichiatria   (Italy)

^p UNIVERSITY OF BARI   (Italy)

^q Dipartimento Interaziendale di Salute Mentale e Dipendenze di Siena   (Italy)

^r Dipartimento di Salute Mentale   (Italy)

^s UNIVERSITY OF GENOA   (Italy)

^t SOC Psichiatria Asti Centro Nord   (Italy)

^u Unit Operativa di Psichiatria No 62   (Italy)

^v UNIVERSITY OF PERUGIA   (Italy)

^w Azienda USL di Ferrara   (Italy)

more..

Author keywords

Deliberate self harm; Lithium; Mortality; Randomised controlled trial; Suicide; Treatment resistant depression

Indexed keywords

ANTIDEPRESSANT AGENT; LITHIUM DERIVATIVE; NEUROLEPTIC AGENT; TRANQUILIZER;

ADULT; AFFECT; CLINICAL TRIAL; CONTROLLED STUDY; DEPRESSION; DRUG COMBINATION; DRUG EFFECTS; FEMALE; HUMAN; ITALY; KAPLAN MEIER METHOD; MALE; METHODOLOGY; MORTALITY; MULTICENTER STUDY; PSYCHOLOGICAL RATING SCALE; PSYCHOLOGY; RANDOMIZED CONTROLLED TRIAL; SAMPLE SIZE; SEVERITY OF ILLNESS INDEX; SUICIDAL IDEATION; SUICIDE; TIME; TREATMENT OUTCOME;

ADULT; AFFECT; ANTIDEPRESSIVE AGENTS; ANTIMANIC AGENTS; ANTIPSYCHOTIC AGENTS; DEPRESSION; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; ITALY; KAPLAN-MEIER ESTIMATE; LITHIUM COMPOUNDS; MALE; PSYCHIATRIC STATUS RATING SCALES; RESEARCH DESIGN; SAMPLE SIZE; SEVERITY OF ILLNESS INDEX; SUICIDAL IDEATION; SUICIDE; TIME FACTORS; TREATMENT OUTCOME;

EID: 84932103677     PISSN: None     EISSN: 17560500     Source Type: Journal    
DOI: 10.1186/1756-0500-7-731     Document Type: Article

References (18)

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, Träskman-Bendz L: Deliberate self harm: systematic review of efficacy of psychosocial and pharmacological treatments in preventing repetition. BMJ 1998, 317:441-447.
2. Hawton K, Townsend E, Arensman E, Gunnell D, Hazell P, House A, van Heeringen K: Psychosocial versus pharmacological treatments for deliberate self harm. Cochrane Database Syst Rev 2000, CD001764. doi:10.1002/14651858.CD001764.
3. Cipriani A, Pretty H, Hawton K, Geddes JR: 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 2005, 162:1805-1819.
4. Cipriani A, Hawton K, Stockton S, Geddes JR: Lithium in the prevention of suicide in mood disorders: updated systematic review and meta-analysis. BMJ 2013, 346:f3646.
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, Nosè M, Occhionero G, et al: 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 2013, 13:212.
6. Moher D, Schulz KF, Altman DG: The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet 2001, 357:1191-1194.
7. Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D, CONSORT group: Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 2008, 337:a2390.
8. Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC: 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 1998, 59(Suppl 20):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: 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 2003, 54:573-583.
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, STAR∗D Study Team: Bupropion-SR, sertraline, or venlafaxine-XR after failure of SSRIs for depression. N Engl J Med 2006, 354:1231-1242.
11. Guzzetta F, Tondo L, Centorrino F, Baldessarini RJ: Lithium treatment reduces suicide risk in recurrent major depressive disorder. J Clin Psychiatry 2007, 68:380-383.
12. Barbui C, Accordini S, Nose M, Stroup S, Purgato M, Girlanda F, Esposito E, Veronese A, Tansella M, Cipriani A: Aripiprazole versus haloperidol in combination with clozapine for treatment-resistant schizophrenia in routine clinical care: a randomized, controlled trial. J Clin Psychopharmacol 2011, 31:266-273.
13. Cipriani A, Accordini S, Nose M, Purgato M, Girlanda F, Tansella M, Barbui C: Aripiprazole versus haloperidol in combination with clozapine for treatment-resistant schizophrenia: a 12-month, randomized, naturalistic trial. J Clin Psychopharmacol 2013, 33:533-537.
14. Ghaemi SN, Dalley S: The bipolar spectrum: conceptions and misconceptions. Aust N Z J Psychiatry 2014, 48:314-324.
15. Ivkovic A, Stern TA: Lithium-induced neurotoxicity: clinical presentations, pathophysiology, and treatment. Psychosomatics 2014, 55:296-302.
16. McIntyre RS, Filteau MJ, Martin L, Patry S, Carvalho A, Cha DS, Barakat M, Miguelez M: Treatment-resistant depression: definitions, review of the evidence, and algorithmic approach. J Affect Disord 2014, 156:1-7.
17. Spielmans GI, Berman MI, Linardatos E, Rosenlicht NZ, Perry A, Tsai AC: Adjunctive atypical antipsychotic treatment for major depressive disorder: a meta-analysis of depression, quality of life, and safety outcomes. PLoS Med 2013, 10:e1001403.
18. Goldacre B: Are clinical trial data shared sufficiently today? No. BMJ 2013, 347:f1880.