TITLE:
Long-Term, Open-Label, Safety Study of Edivoxetine as Adjunctive Treatment for Adult Patients with Major Depressive Disorder Who Were Partial Responders to Selective Serotonin Reuptake Inhibitor Treatment in Japan
AUTHORS:
Emel Serap Monkul, Mark Bangs, Keita Asato, Masashi Takahashi, Yasushi Takita, Mary Anne Dellva, Jonna Ahl, Celine Goldberger
KEYWORDS:
Edivoxetine, Depression, SSRI, NRI, Japan, Adjunctive Therapy
JOURNAL NAME:
Open Journal of Psychiatry,
Vol.5 No.2,
April
13,
2015
ABSTRACT: Edivoxetine is a highly
selective norepinephrine reuptake inhibitor (NRI) that has been investigated in
short-term studies as adjunctive therapy toselective
serotonin reuptake inhibitor antidepressants (SSRIs) in patients with major
depressive disorder (MDD) who were partial responders to their SSRIs. This
52-week open-label study investigated the safety and tolerability of
longer-term treatment with adjunctive edivoxetine in patients with MDD in
Japan, who had completed one of two placebo-controlled acute studies of
edivoxetine as adjunctive therapy to SSRIs. All patients continued on their
stable dose of SSRI. Two hundred eighty-eight patients were enrolled and
assessed for up to 1 year using standard safety and tolerability measures. Of
these, 195 patients previously received only placebo in the parent study and,
therefore, were first exposed to edivoxetine in this study. Approximately 46%
of patients completed the study. The most frequently cited (>5%) reasons for
discontinuation were sponsor decision (19.4%, which included patients
discontinued due to early study termination), adverse event (17.4%) and subject
decision (8.7%). Adverse events leading to discontinuation in more than 2
patients (>1%) were palpitations, vomiting, hepatic function abnormal,
hypertension, nausea, and tachycardia. Treatment-emergent elevations in
diastolic blood pressure and pulse were at least twice that reported in the
literature for non-Asian patients. Twenty percent of patients had sustained elevations
in pulse. Treatment-emergent changes in laboratory measures were small and not
clinically meaningful. Assessment across all safety measures in this study
indicated that the safety profile of edivoxetine was consistent with that
expected for a selective NRI.