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

This study has been terminated.
(Due to slow enrollment the study was terminated early)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01436643
First received: September 16, 2011
Last updated: September 24, 2014
Last verified: September 2014

September 16, 2011
September 24, 2014
November 2011
September 2013   (final data collection date for primary outcome measure)
Number of Participants Who Experienced Adverse Events, Serious Adverse Events and Death [ Time Frame: 21 weeks ] [ Designated as safety issue: Yes ]

In this analysis patients with all (serious and non-serious) adverse events, and death were reported.

See Safety Section.

Safety and tolerability profile of the combination therapy of an antidepressant type SSRI or SNRI with oral fingolimod with respect to adverse events and laboratory parameters [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01436643 on ClinicalTrials.gov Archive Site
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Combination of Antidepressants and Fingolimod Relapsing-remitting Multiple Sclerosis (RRMS) Patients With Depression
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

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Depression
  • Relapsing-remitting Multiple Sclerosis
  • Drug: Venlafaxine
    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
  • Drug: Fluoxetine
    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
  • Drug: Citalopram
    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
  • Drug: Fingolimod
    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.
  • Experimental: Fluoxetine and Fingolimod
    Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Fluoxetine, supplied in blistered packs containing 20 tablets; starting dose 20 mg; final dose 40 mg
    Interventions:
    • Drug: Fluoxetine
    • Drug: Fingolimod
  • Experimental: Venlafaxine and Fingolimod
    Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Venlafaxine, supplied in blistered packs containing 14 capsules; starting dose 75 mg; final dose 150 mg
    Interventions:
    • Drug: Venlafaxine
    • Drug: Fingolimod
  • Experimental: Citalopram and Fingolimod
    Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Citalopram, supplied in blistered packs containing 20 tablets; starting dose 20 mg, final dose 40 mg
    Interventions:
    • Drug: Citalopram
    • Drug: Fingolimod
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
54
September 2013
September 2013   (final data collection date for primary outcome measure)

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

Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01436643
CFTY720DDE06, 2011-001692-39
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP