TITLE:
Fluvoxamine in Treatment of Depression in Russian Patients: An Open-Label, Uncontrolled and Non-Randomized Multicenter Observational Study
AUTHORS:
Anatoly Boleslavovich Smulevich, Natalia Alekseevna Ilyina, Victoria Valentinovna Chitlova
KEYWORDS:
Fluvoxamine, Depression, Hamilton Rating Scale of Depression, Routine Settings
JOURNAL NAME:
Open Journal of Psychiatry,
Vol.5 No.4,
October
7,
2015
ABSTRACT: Background: Fluvoxamine, a
selective serotonin reuptake inhibitor is widely used in the treatment of
depression, one of the most common disorders prevalent in Russia. However,
studies demonstrating its efficacy and safety in routine settings in Russia are
scarce. Methods: This prospective, uncontrolled,
open-label study was conducted at 11 centers in Russia. Total 293 patients
(aged ≥ 18 years), meeting DSM-IV
criteria for depression and scoring ≥ 17 on 17-item Hamilton Rating Scale of
Depression (HAMD-17) received fluvoxamine 50 - 300 mg for 6 weeks. Primary
efficacy measures included change from baseline in the HAMD-17 and Clinical
Global Impression (CGI) scores. Secondary efficacy measure was evaluation of
sleep quality changes on HAMD-17 subscale. Safety was assessed by monitoring of
adverse drug reactions (ADRs). Results: Mean age of patients was 42.7 years and
the majority of them were women (72%). At the end of treatment (day 42),
clinically significant reduction was observed in mean HAMD-17, CGI-severity of
illness and HAMD-17 sleep sub-score from 23.1, 4.5 and 3.9 at baseline to day
42; change from baseline (Δ) was: Δ-17.3 [95% CI: -18.0; -16.7]), Δ-2.1 and Δ-3.4 [95% CI: -3.53; -3.20]), respectively. At day 42, 20.8% patients reported
as normal (not at all ill) on the CGI-severity scale and 85% patients reported
as “much improved” or “very much improved” on the CGI-change in severity and
quality of life scores. Nausea (12.6%) and somnolence (5.1%) were the most
frequently reported ADRs. No deaths or serious ADRs were reported but eight
patients discontinued treatment due to ADRs. Conclusion: Treatment with
fluvoxamine under routine settings showed marked improvement in Russian
patients with depression as measured by HAMD-17 and CGI ratings and was thus
efficacious as well as safe and well-tolerated.