Fingolimod (Gilenya®) in Combination with an SSRI or SNRI Antidepressant in Multiple Sclerosis Patients with Mild to Moderate Depression: Design of a Phase IIIb Study (REGAIN) (P01.135)

Objective: The primary endpoint is the safety and tolerability profile of the combination of an SSRI or SNRI antidepressant with fingolimod in MS patients (expanded disability status scale (EDSS) 0–6.5) who are suffering mild to moderate depression (BDI-II 14-28). In addition, the efficacy of the combination therapy on quality of life, treatment satisfaction and other MS related sequelae will be exploratively assessed. Furthermore, in terms of health economics, the MS-specific and depression-specific use of resources will be evaluated. Background Almost half of all patients with multiple sclerosis (MS) are affected by concomitant psychological diseases, depression being most frequent (46%). The 12-month prevalence of depression in MS patients is 26%, which is three times higher than in the general population. Although some studies have shown a positive effect of selective serotonin/noradrenaline or serotonin re-uptake inhibitors (SNRIs or SSRIs, respectively), there is currently no established drug treatment of depression in MS patients. Therefore, in this open-label study, the safety and tolerability of the combination of fingolimod and an SSRI or SNRI antidepressant will be investigated in MS patients with mild to moderate depression. Design/Methods: In the REGAIN study ( R educe d E pression with G ilenya A nd SNRI/SSRI ant I depressant in MS-patie N ts) 375 patients with relapsing remitting MS and a mild to moderate depression, will be included. Patients will be pre-treated for 2 weeks with fingolimod, followed by a 16-week concomitant antidepressant treatment phase, with either an SSRI or an SNRI (Citalopram, Fluoxetine or Venlafaxine), at the discretion of the investigator, while maintaining on fingolimod therapy. After 8 and 16 weeks, the safety and tolerability of the combination therapy will be assessed. Results: Baseline demographics will be available in April 2012. Conclusions: This study will provide first-time data on the safety and tolerability of a combination therapy of fingolimod and an SSRI or SNRI antidepressant in MS patients with mild to moderate depression. Supported by: Novartis Pharma GmbH; Germany. Disclosure: Dr. Schuh has received personal compensation for activities with Novartis as an employee. Dr. Meergans has received personal compensation for activities with Novartis as an employee. Dr. Bayas has received personal compensation for activities as a investigator.