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.
BACKGROUND
Data on therapeutic interventions following deliberate self harm (DSH) in patients with treatment-resistant depression (TRD) are very scant and there is no unanimous consensus on the best pharmacological option for these patients. There is some evidence that lithium treatment might be effective in reducing the risk of completed suicide in adult patients with unipolar affective disorders, however no clear cut results have been found so far. The primary aim of the present study is to assess whether adding lithium to standard therapy is an effective treatment strategy to reduce the risk of suicidal behaviour in long term treatment of people with TRD and previous history of DSH.


METHODS
We will carry 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 will be allocated to add lithium to current therapy (intervention arm) or not (control arm). Following randomisation, treatment is to be taken daily for 1 year unless some clear reason to stop develops. Suicide completion and acts of DSH during the 12 months of follow-up will constitute the composite primary outcome. To preserve outcome assessor blindness, an independent adjudicating committee, blind to treatment allocation, will anonymously review all outcome events.


CONCLUSIONS
The results of this study should indicate whether lithium treatment is associated with lower risk of completed suicide and DSH in adult patients with treatment resistant unipolar depression, who recently attempted suicide.


BACKGROUND
ClinicalTrials.gov identifier: NCT00927550.
Dipartimento di Sanità Pubblica e Medicina di Comunità, Sezione di Psichiatria e Sezione di Psicologia Clinica, Università di Verona, Policlinico G,B, Rossi Piazzale L.A. Scuro, Verona, 10 - 37134, Italy. andrea.cipriani@univr.it
Andrea
A
Cipriani
Francesca
F
Girlanda
Emilia
E
Agrimi
Andrea
A
Barichello
Rossella
R
Beneduce
Irene
I
Bighelli
Giulia
G
Bisoffi
Alfredo
A
Bisogno
Paola
P
Bortolaso
Marianna
M
Boso
Carmela
C
Calandra
Liliana
L
Cascone
Caterina
C
Corbascio
Vincenzo Fricchione
VF
Parise
Francesco
F
Gardellin
Daniele
D
Gennaro
Batul
B
Hanife
Camilla
C
Lintas
Marina
M
Lorusso
Chiara
C
Luchetta
Claudio
C
Lucii
Francesco
F
Cernuto
Fiorella
F
Tozzi
Alessandra
A
Marsilio
Francesca
F
Maio
Chiara
C
Mattei
Daniele
D
Moretti
Maria Grazia
MG
Appino
Michela
M
Nosè
Guglielmo
G
Occhionero
Duccio
D
Papanti
Damiano
D
Pecile
Marianna
M
Purgato
Davide
D
Prestia
Francesco
F
Restaino
Tiziana
T
Sciarma
Alessandra
A
Ruberto
Stefania
S
Strizzolo
Stefania
S
Tamborini
Orlando
O
Todarello
Simona
S
Ziero
Spyridon
S
Zotos
Corrado
C
Barbui
D000328:Adult; D000928:Antidepressive Agents / Q000627:therapeutic use*; D018692:Antimanic Agents / Q000627:therapeutic use; D002985:Clinical Protocols; D061218:Depressive Disorder, Treatment-Resistant / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008094:Lithium / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012107:Research Design; D012306:Risk; D016728:Self-Injurious Behavior; D013405:Suicide; D016896:Treatment Outcome
D000928:Antidepressive Agents; D018692:Antimanic Agents; D008094:Lithium