Longitudinal analysis of the suicidal behaviour risk in short-term placebo-controlled studies of mirtazapine in major depressive disorder.
OBJECTIVE
To examine suicidal behaviour risk in the short-term placebo-controlled studies of mirtazapine in Major Depressive Disorder (MDD).


METHODS
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).


CONCLUSIONS
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.
Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria. sci-biolpsy@meduniwien.ac.at
Siegfried
S
Kasper
Stuart A
SA
Montgomery
Hans-Jürgen
HJ
Möller
Helga J J
HJ
van Oers
Albert
A
Jan Schutte
Peter
P
Vrijland
Egbert A
EA
van der Meulen
D000328:Adult; D000929:Antidepressive Agents, Tricyclic / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy*; D039721:Diagnostic and Statistical Manual of Mental Disorders; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008803:Mianserin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000078785:Mirtazapine; D015990:Placebo Effect; D012720:Severity of Illness Index; D013406:Suicide, Attempted / Q000523:psychology* / Q000706:statistics & numerical data*
D000929:Antidepressive Agents, Tricyclic; D008803:Mianserin; D000078785:Mirtazapine