title: Combination treatment of fingolimod with antidepressants in relapsing-remitting multiple sclerosis patients with depression: a multicentre, open-label study - REGAIN.
abstract: OBJECTIVE
  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 clinical studies. Adverse events (mostly mild-to-moderate) were reported in 43 patients. A total of three patients had serious adverse events and 10 discontinued the study. QoL (mean [95% confidence interval]) improved by 2.2 (-3.3, -1.2; Patient Reported Indices for MS questionnaire), fatigue by 8.2 (-13.1, -3.3; modified Fatigue Impact Scale) and depression by 6.3 (-8.4, -4.2; Hamilton Depression Scale) points. However, the results must be interpreted cautiously owing to limited patient numbers.
  
  
  CONCLUSIONS
  Combination of fingolimod with antidepressant medication showed no unexpected safety signals. Patient-reported outcomes (QoL, disability, fatigue and depression) remained stable or improved.
authors: Department of Neurology, Klinikum Augsburg, Stenglinstrasse 2, D-86156 Augsburg, Germany.
authors: Antonios
authors: A
authors: Bayas
authors: Novartis Pharma, Nuremberg, Germany.
authors: Katrin
authors: K
authors: Schuh
authors: Novartis Pharma, Nuremberg, Germany.
authors: Monika
authors: M
authors: Baier
authors: Novartis Pharma, Nuremberg, Germany.
authors: Stefan Viktor
authors: SV
authors: Vormfelde
keywords: FTY720; Gilenya®; depression; fatigue; fingolimod; multiple sclerosis