This is a prospective, multi-center, open-label study in Relapsing-remitting Multiple Sclerosis (RRMS) patients with mild to moderate depression treated with selected serotonin reuptake inhibitors (SSRI) or serotonin and norepinephrine reuptake inhibitors (SNRI) antidepressants over 16 weeks as add-on to fingolimod treatment. It is designed to evaluate the safety and tolerability of this combination in this patient population based on an immunomodulatory treatment with fingolimod.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Venlafaxine starting dose was 75 mg and given once daily for at least 7 days and a maximum of 28 days. Dosage was increased afterwards to the individual final dose given once daily, i.e. after at least 7 days and a maximum of 28 days, patients were titrated to their maximum dose of 150 Mg
Fluoxetine starting dose was 20 mg and given once daily for at least 7 days and a maximum of 28 days. Dosage was increased afterwards to the individual final dose given once daily, i.e. after at least 7 days and a maximum of 28 days, patients were titrated to their maximum dose of 40 Mg
Citalopram starting dose was 20 mg and given once daily for at least 7 days and a maximum of 28 days. Dosage was increased afterwards to the individual final dose given once daily, i.e. after at least 7 days and a maximum of 28 days, patients were titrated to their maximum dose of 40 Mg
Dosage of 0.5 mg per capsule (hard gelatin capsules) was taken p.o. once daily. Fingolimod was supplied in bottles containing 35 capsules each.
Novartis Investigative Site
Altenholz-Stift, Germany, Germany
Novartis Investigative Site
Achim, Germany
Novartis Investigative Site
Aschaffenburg, Germany
Novartis Investigative Site
Bad Honnef, Germany
Novartis Investigative Site
Baesweiler, Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Bielefeld, Germany
Novartis Investigative Site
Bielefeld, Germany
Novartis Investigative Site
Bochum, Germany
Novartis Investigative Site
Bremerhaven, Germany
...and 15 more locations
Number of Participants Who Experienced Adverse Events, Serious Adverse Events and Death
In this analysis patients with all (serious and non-serious) adverse events, and death were reported. See Safety Section.
Time frame: 21 weeks
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