Prophylactic effects or withdrawal reactions? An analysis of time-to-event data from antidepressant relapse prevention trials submitted to the FDA

Prof. Peter Gøtzsche has tweeted: “When you stop taking a depression pill and feel bad, psychiatrists tell you that you have relapsed. Not so. By far most, perhaps even all your troubles, are withdrawal symptoms … Never stop abruptly. This is dangerous, as the pills cause addiction.”

The study that Prof. Gøtzsche is referring to – “Prophylactic effects or withdrawal reactions? An analysis of time-to-event data from antidepressant relapse prevention trials submitted to the FDA” – has been published in Therapeutic Advances in Psychopharmacology.

The study’s background summary says:

“Relapse prevention trials build the scientific foundation for recommendation of antidepressant continuation and maintenance therapy. However, the validity of the evidence is disputed and may be biased due to withdrawal confounding.”

You can go here to see a summary of the study’s methods and results (and to read the study in full), but the summary of its conclusion says:

“The placebo–antidepressant separation was disproportionally large between weeks 3 and 6 of the randomised maintenance phase. The benefits of continuing antidepressants relative to abrupt/rapid discontinuation declined sharply after week 6. This indicates an excess of relapse events in the placebo arms during the early maintenance phase that may be due to withdrawal reactions caused by abrupt/rapid discontinuation of active treatment. If these early relapse events are due to a direct pharmacological effect, then antidepressants’ true prophylactic long-term effects are substantially overestimated.”

Any reply would be very welcome

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