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.
Kasper
Siegfried
S
Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria. sci-biolpsy@meduniwien.ac.at
Montgomery
Stuart A
SA
Möller
Hans-Jürgen
HJ
van Oers
Helga J J
HJ
Jan Schutte
Albert
A
Vrijland
Peter
P
van der Meulen
Egbert A
EA
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