EPA-1061 – Agomelatine in the Treatment of Perimenopausal Depression - A Pilot Study

Abstract

Aim:

Aim of this study was to investigate whether agomelatine relieves both symptoms of depression and physical symptoms in women in the perimenopausal transition

Method:

This study is an open, randomized, non-controlled pilot study. Agomelatine was administered at the single daily dose of 25mg over 6 weeks to 50 women with first-onset perimenopausal depression (mean age 52-SD 4.8-years). Perimenopause was determined by subjetcs’ reports and hormonal assessment. Outcome measures included MINI (once for assessment of DSM-IV diagnosis of depression) at the beginning of the study and Hamilton Depression Rating Scale (HAMD), Montgomery Asberg Depression Scale (MADRS), Pittsburgh Sleep Quality Index (PSQI) as well as Menopause Rating Scale II, which were assessed weekly. Adverse drug reactions (ADRs) were documented at every visit.

Results:

At inclusion, women had moderate depression with a mean HAM-D-score of 17 and a mean MADRS-score of 19. Over the study period, agomelatine significantly improved depression and perimenopausal physical symptoms in all women. This was particularly evident for hot flashes, decreased performance, sexual problems, heartaches and joint/muscle pain. In addition, anxiety, irritability and disordered sleep improved as well. At the end of the study, women reported to be basically free of both physical and psychological symptoms of perimenopause. Agomelatine showed good tolerability, majority of the women reported no side-effects. Only in the first 2 weeks tiredness was reported by about 10% of the subjects.

Conclusion:

The findings demonstrated that agomelatine significantly improved symptoms of depression and physical symptoms related to perimenopause over 6 weeks. Further, good tolerability was observed.