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Combination of Antidepressants and Fingolimod Relapsing-remitting Multiple Sclerosis (RRMS) Patients With Depression

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depression; Relapsing-remitting Multiple Sclerosis

Intervention: Venlafaxine (Drug); Fluoxetine (Drug); Citalopram (Drug); Fingolimod (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

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.

Clinical Details

Official title: A 21-week, Multicenter, Open Label Study to Evaluate the Safety and Tolerability Profile of the Combination of a SSRI or SNRI Antidepressive Therapy With Oral Fingolimod in the Treatment of RRMS Patients With Mild to Moderate Depression

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Participants Who Experienced Adverse Events, Serious Adverse Events and Death

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Novartis Investigative Site, Achim 28832, Germany

Novartis Investigative Site, Altenholz-Stift 24161, Germany

Novartis Investigative Site, Aschaffenburg 63739, Germany

Novartis Investigative Site, Bad Honnef 53604, Germany

Novartis Investigative Site, Baesweiler 52499, Germany

Novartis Investigative Site, Berlin 12621, Germany

Novartis Investigative Site, Bielefeld 33602, Germany

Novartis Investigative Site, Bielefeld 33647, Germany

Novartis Investigative Site, Bochum 44787, Germany

Novartis Investigative Site, Bremerhaven 27574, Germany

Novartis Investigative Site, Butzbach 35510, Germany

Novartis Investigative Site, Grevenbroich 41515, Germany

Novartis Investigative Site, Heidenheim 89518, Germany

Novartis Investigative Site, Klingenmünster 76889, Germany

Novartis Investigative Site, Leipzig 04275, Germany

Novartis Investigative Site, Merzig 66663, Germany

Novartis Investigative Site, Nienburg 31582, Germany

Novartis Investigative Site, Oberhausen 46045, Germany

Novartis Investigative Site, Oldenburg 26122, Germany

Novartis Investigative Site, Potsdam 14471, Germany

Novartis Investigative Site, Schwalmstadt-Treysa 34613, Germany

Novartis Investigative Site, Stadtroda 07646, Germany

Novartis Investigative Site, Tübingen 72076, Germany

Novartis Investigative Site, Weil am Rhein 79576, Germany

Novartis Investigative Site, Zwickau 08060, Germany

Additional Information

Starting date: November 2011
Last updated: September 24, 2014

Page last updated: August 23, 2015

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