Combination treatment of fingolimod with antidepressants in relapsing-remitting multiple sclerosis patients with depression: a multicentre, open-label study - REGAIN.

ABSTRACT:

Objectives

Approximately one in two patients with multiple sclerosis (MS) suffer from comorbid depression. The primary objective of this study was to evaluate the safety and tolerability of fingolimod and antidepressant combination in relapsing-remitting MS patients with mild-to-moderate depression. Efficacy outcome variables were quality of life (QoL), fatigue, disability and depression.

Methods

Patients received open-label fingolimod 0.5 mg over 2 weeks, followed by fingolimod plus citalopram (40 mg), fluoxetine (40 mg) or venlafaxine (150 mg) over 16 weeks. The antidepressant was selected at the physician's discretion.

Results

In total, 54 patients were recruited at 25 centres across Germany. No new safety signals (including cardiac) emerged compared with previous

SUBMITTER: Bayas A 

PROVIDER: S-EPMC4994781 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature