Comparable efficacy and safety of 8 weeks treatment with agomelatine 25–50 mg or fluoxetine 20–40 mg in Asian out-patients with major depressive disorder

Mar 25, 2014Asian journal of psychiatry

Similar effectiveness and safety of 8-week treatment with agomelatine or fluoxetine in Asian outpatients with major depression

AI simplified

Long Covid on OpenScience ↗PubMed ↗DOI ↗

Abstract

Agomelatine and fluoxetine showed comparable antidepressant efficacy with mean changes of -14.8 and -15.0 on the Hamilton Depression Rating Scale after 8 weeks.

Both treatments resulted in similar, clinically relevant reductions in depression scores.
Statistical analysis confirmed non-inferiority between agomelatine and fluoxetine (p=0.015).
Improvements were also noted in anxiety and sleep symptoms for both treatment groups.
Agomelatine was found to have a good tolerability profile and safety in the Asian population.

AI simplified

OBJECTIVE: This randomized, double-blind study evaluates the efficacy and tolerability of agomelatine, using fluoxetine as an active comparator, in Asian patients suffering from moderate to severe major depressive disorder (MDD).

METHOD: Patients were randomly assigned to receive either agomelatine (25-50mg/day, n=314) or fluoxetine (20-40mg/day, n=314) during an 8-week treatment period. The main outcome measure was the change in Hamilton Depression Rating Scale 17 items (HAM-D17) scores. Secondary efficacy criteria included scores on Clinical Global Impression Severity of illness (CGI-S) and Improvement of illness (CGI-I), patient sleeping improvement using the self-rating Leeds Sleep Evaluation Questionnaire (LSEQ) and anxiety using the Hamilton Anxiety Rating Scale (HAM-A) scores. Tolerability and safety evaluations were based on emergent adverse events.

RESULTS: Agomelatine and fluoxetine exert a comparable antidepressant efficacy in the Asian population. Mean changes over 8 weeks were clinically relevant and similar in both groups (-14.8±7.3 and -15.0±8.1 on HAM-D17 scale in agomelatine and fluoxetine groups, respectively). The between-group difference reached statistical significance on non-inferiority test (p=0.015). Clinically relevant decreases in CGI-S and CGI-I scores were observed over the treatment period in both groups. The two treatments were equally effective on the symptoms of both anxiety and sleep. The good tolerability profile and safety of both doses of agomelatine was confirmed in the Asian population.

CONCLUSIONS: Agomelatine and fluoxetine are equally effective in the treatment of MDD-associated symptoms in Asian depressed patients.

Full Text

Full text is available at the source.

View full text (XML) ↗View full text ↗

Comparable efficacy and safety of 8 weeks treatment with agomelatine 25–50 mg or fluoxetine 20–40 mg in Asian out-patients with major depressive disorder

Abstract

Full Text

You found one interesting study. We’ll send the next 7.

what lands in your inbox each week:

Recent issues from the long covid brief

Abstract

Full Text

Related papers

You found one interesting study. We’ll send the next 7.

what lands in your inbox each week:

Recent issues from the long covid brief