Even more suicide attempts in clinical trials with paroxetine randomised against placebo
2006

Increased Suicide Attempts Linked to Paroxetine

Sample size: 5433 publication Evidence: high

Author Information

Author(s): Aursnes Ivar, Tvete Ingunn Fride, Gaasemyr Jorund, Natvig Bent

Primary Institution: University of Oslo

Hypothesis

Is paroxetine associated with an increased intensity of suicide attempts compared to placebo?

Conclusion

The study confirms that paroxetine is associated with an increased intensity of suicide attempts.

Supporting Evidence

  • 11 suicide attempts were reported among patients on paroxetine compared to 1 on placebo.
  • The posterior probability that paroxetine increases suicide attempts is between 0.98 and 0.99.
  • GSK admitted to an increased risk for suicide attempts associated with paroxetine in their Briefing Document.

Takeaway

Taking paroxetine might make people more likely to try to harm themselves compared to not taking it.

Methodology

The study analyzed data from 19 double-blind, parallel design studies comparing paroxetine to placebo using Bayesian techniques.

Potential Biases

Potential bias due to the inclusion of patients with a history of suicide attempts in both treatment and placebo groups.

Limitations

The study did not have access to the points of time of censoring, which may affect the accuracy of patient years computed.

Participant Demographics

Patients included in the studies were adults, with a total of 3455 on paroxetine and 1978 on placebo.

Statistical Information

P-Value

0.058

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1186/1471-244X-6-55

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