Lithium and Standard Therapy in Resistant Depression

Summary

The principal clinical question is whether lithium is effective in reducing the risk of suicidal behaviour in subjects with treatment-resistant depression and suicide risk. Additionally aims of the study are: (a) to assess whether lithium is effective in improving depressive symptomatology in subjects with treatment-resistant depression and suicide risk; (b) to assess the tolerability profile of lithium.

Timeline

Start

2009-06

Primary completion

2012-12

Completion

2012-12

Outcome

Missed primary endpoint

paper The survival probability did not differ between the two treatment arms (Chi2 = 0.17, p =0.676). PMID 25326163 ↗

paper 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 PMID 25326163 ↗

Publications

• Girlanda F, Cipriani A, Agrimi E, Appino MG, Barichello A, Beneduce R, Bighelli I, Bisoffi G, Bisogno A, Bortolaso P, Boso M, Calandra C, Cascone L, Castellazzi M, Corbascio C, Parise VF, Gardellin F, Gennaro D, Hanife B, Lintas C, Lorusso M, Luca A, Luca M, Luchetta C, Lucii C, Maio F, Marsilio A, Mattei C, Moretti D, Nose M, Occhionero G, Papanti D, Pecile D, Percudani M, Prestia D, Purgato M, Restaino F, Romeo S, Sciarma T, Strizzolo S, Tamborini S, Todarello O, Tozzi F, Ziero S, Zotos S, Barbui C. Effectiveness of lithium in subjects with treatment-resistant depression and suicide risk: results and lessons of an underpowered randomised clinical trial. BMC Res Notes. 2014 Oct 17;7:731. doi: 10.1186/1756-0500-7-731.
• 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, Nose M, Occhionero G, Papanti D, Pecile D, Purgato M, Prestia D, Restaino F, Sciarma T, Ruberto A, Strizzolo S, Tamborini S, Todarello O, Ziero S, Zotos S, Barbui C. 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 Aug 13;13:212. doi: 10.1186/1471-244X-13-212.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lithium	Unknown	150 mg	Oral
Subject	Lithium	Unknown	300 mg	Oral

Indications