Longitudinal analysis of the suicidal behaviour risk in short-term placebo-controlled studies of mirtazapine in major depressive disorder

World J Biol Psychiatry. 2010 Feb;11(1):36-44. doi: 10.3109/15622970701691503.

Abstract

Objective: To examine suicidal behaviour risk in the short-term placebo-controlled studies of mirtazapine in Major Depressive Disorder (MDD).

Method: Longitudinal Generalized Estimating Equations analyses were performed on pooled data from 15 placebo-controlled, randomized, double-blind, short-term trials of mirtazapine, using the suicide item scores from the Hamilton Depression Rating Scale (HAMD) as a proxy outcome measure for suicidality risk.

Results: The overall analysis using the convention that a patient is at risk if the HAMD suicide item score is > or =3, and excluding patients at risk at baseline, demonstrated a statistically significantly lower risk for mirtazapine- compared to placebo-treated patients on the HAMD (odds ratio mirtazapine versus placebo 0.38; 95% confidence interval 0.21-0.66; P= 0.0008).

Conclusion: Our results based on pooled data from 15 placebo-controlled, short-term studies of mirtazapine in MDD using the suicide item scores from the HAMD as a proxy outcome measure for suicidality risk, demonstrate that mirtazapine was associated with statistically significantly lower suicidality risk compared to placebo.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Antidepressive Agents, Tricyclic / therapeutic use*
  • Depressive Disorder, Major / diagnosis
  • Depressive Disorder, Major / drug therapy*
  • Diagnostic and Statistical Manual of Mental Disorders
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Mianserin / analogs & derivatives*
  • Mianserin / therapeutic use
  • Mirtazapine
  • Placebo Effect
  • Severity of Illness Index
  • Suicide, Attempted / psychology*
  • Suicide, Attempted / statistics & numerical data*

Substances

  • Antidepressive Agents, Tricyclic
  • Mianserin
  • Mirtazapine