combination of antidepressants and fingolimod relapsing-remitting multiple sclerosis (rrms) patients with depression

Conditions: Depression; Relapsing-remitting Multiple Sclerosis

Summary: 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.


Eligibility criteria:
inclusion criteria: * subjects with relapsing remitting ms defined by 2010 revised mcdonald criteria (see appendix 4) * patients with expanded disability status scale (edss) score of 0-6.5 (see appendix 8) * patients with high disease activity despite treatment with a disease modifying therapy (\> 1 relapse in the previous year, \> 9 hyperintense t2 lesions or \> 1 gd-enhancing lesion or "non-responding" which could be defined as unchanged or increased relapse rate or ongoing severe relapses compared to previous year)or patients with rapidly evolving severe rrms (e.g. \> 2 relapses with disease progression in one year and \> 1 gd-enhancing lesion or with a significant increase in t2 lesions compared to a recent mri) * depression according to icd-10 criteria * mild-moderate depression assessed by bdi-ii score between 14-28 inclusively measured before study inclusion and before fingolimod is administered exclusion criteria: * patients with a history of chronic disease of the immune system other than ms which requires systemic immunosuppressive treatment, or a known immunodeficiency syndrome. patients with crohns disease or ulcerative colitis are excluded without exception * history or presence of malignancy (other than localized basal or squamous cell carcinoma of the skin) * patients with active systemic bacterial, viral or fungal infections, or known to have aids, hepatitis b, hepatitis c infection or to have positive hiv antibody, hepatitis b surface antigen or hepatitis c antibody tests * negative for varicella-zoster virus igg antibodies at screening * patients who expect to be treated with any disease modifying drugs (dmd) during the study (i.e. ifn-β, glatiramer acetate); however no washout is needed for dmds prior to start of fingolimod * patients who are or have been treated with: * immunoglobulins and/or monoclonal antibodies (including natalizumab) within 3 months prior to start of fingolimod * systemically applied corticosteroids or adrenocorticotropic hormones (acth) within 1 month prior to start of fingolimod (nevertheless, topical application is permitted); * immunosuppressive medications such as azathioprine or methotrexate, within 3 months prior to start of fingolimod; * cyclophosphamid and mitoxantrone within 6 months prior to start of fingolimod * cladribine at any time * current psychological or pharmacological treatment for depression (mao inhibitors in particular), a washout period of 1 month prior start of fingolimod is required * current treatment with linezolid, a washout period of 1 month prior start of fingolimod is required other protocol-defined inclusion/exclusion criteria may apply

Keywords: depression multiple sclerosis fingolimod venlafaxine fluoxetine