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What is the risk of suicidal behaviour within clinical trials of antidepressants in adults?
Primary outcome: definitive suicidal behaviour or ideation (completed suicide, attempted suicide or preparatory acts), secondary outcome: suicidal behaviour (preparatory actions).
Systematic review with meta-analysis.
Data requested from 8 industry sponsors of 12 marketed antidepressant products were used. FDA-specified data formats provided instructions for identifying and classifying events possibly related to suicidality and how events would be classified. The search date was not reported, and the majority of trials were unpublished.
Study selection and analysis:
Double-blind randomised placebo-controlled trials assessed the use of one of the 12 antidepressants in adults for any indication of suicidality. The antidepressants were bupropion, citalopram, duloxetine, escitalopram, fluoxetine, fluoxetine/olanzapine (ultimately excluded from the analysis), fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline and venlafaxine. A total of 372 trials (n=99 231) were included in the dataset. Trials limited to known drug responders, those with fewer than 20 participants, studies not providing patient level data and studies with non-antidepressant active control were excluded. Individual patient-level data were analysed using a conditional logistic regression model. Heterogeneity between studies was assessed.
There were a total of 8 (0.01%) completed suicides, 134 (0.14%) attempted suicides …
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