Introduction: A assess the efficacy of mirtazapine in the treatment of depression with somatic symptoms in a 3-months follow-up study.
Design: multicenter, prospective, observational, open-label, and non controlled study.
Sample: seven hundred and eleven patients recruited in outpatient psychiatric consultations by 98 psychiatrists nationwide.
Instruments: 17-Item Hamilton Depression Rating Scale (HAMD-17) and Standardized Polyvalent Psychiatric Interview (SPPI), somatic symptoms section. Patients were assessed pretreatment and at 15, 30 and 90 days post-treatment.
Results: Severity of depression assessed by HAMD-17 significantly decreased (p<0.0001) from 23.27 in the pretreatment assessment to 6.75 at 3 months post-treatment. Severity of somatic symptoms assessed by EPEP significantly decreased (p<0.0001) from 7.68 in the pre-treatment assessment to 2.28 at 3 months post-treatment. Mirtazapine modifies attribution of somatic symptoms in somatizers: in pretreatment assessment, 41.3 % of the sample attributed somatic symptoms to a psychological origin, while at 3 months post-treatment this percentage significantly increased (p<0.05) to 63.94%. Nearly half of the sample (48.52%) took benzodiazepines at the start of the study; but at 3 months post-treatment only 6.71% of the patients needed them. The incidence of adverse effects was 13.36% of the patients. From the total dropouts 4% were due to adverse events.
Conclusions: Mirtazapine is an effective and safe antidepressant for the treatment of depression with somatic symptoms and is able to modify attribution of somatic symptoms in somatizing patients.