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.

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

Calandra, Carmela;Luca, Antonina;Luca, Maria;
2014

Abstract

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.
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; Sample Size; Severity of Illness Index; Suicide; Time Factors; Treatment Outcome; Research Design; Suicidal Ideation
File in questo prodotto:
Non ci sono file associati a questo prodotto.

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/20.500.11769/360397
Citazioni
  • ???jsp.display-item.citation.pmc??? 4
  • Scopus 20
  • ???jsp.display-item.citation.isi??? ND
social impact