Status:
TERMINATED
Combination of Antidepressants and Fingolimod Relapsing-remitting Multiple Sclerosis (RRMS) Patients With Depression
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Depression
Relapsing-remitting Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 (SS...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01436643
Start Date
November 1 2011
End Date
September 1 2013
Last Update
September 25 2014
Active Locations (25)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Altenholz-Stift, Germany, Germany, 24161
2
Novartis Investigative Site
Achim, Germany, 28832
3
Novartis Investigative Site
Aschaffenburg, Germany, 63739
4
Novartis Investigative Site
Bad Honnef, Germany, 53604