Fluoxetine therapy in multiple sclerosis: a double blind, randomised, placebo-controlled, phase II study in patients with relapsing multiple sclerosis

Completed

• Conditions: Multiple sclerosis (MS); Nervous System Diseases; Multiple sclerosis

• Registration Number: ISRCTN65586975
• Lead Sponsor: niversity Medical Center Groningen (UMCG) (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-27
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Written informed consent
2. Male and female patients aged 18 to 65 years inclusive
3. Confirmed diagnosis of MS, as defined by the McDonald criteria
4. Relapsing remitting or relapsing secondary progressive MS, as defined by the Lublin Criteria
5. At least one documented clinical or subclinical (defined as a gadolinium enhanced lesion on magnetic resonance imaging [MRI] examination) exacerbation in the last year or two documented exacerbations in the last 2 years (one of which can be subclinical) or the presence of one gadolinium enhanced lesion on the week 4 MRI scan
6. Baseline Expanded Disability Scoring Scale (EDSS) score of 0.0 - 6.0 inclusive

Exclusion Criteria

1. Intolerance or contraindications to MRI scanning
2. Abnormal MRI scan, not attributable to MS
3. Neurological disorder other than MS, acute or chronic infection, malignant neoplasm or metastasis, cardiovascular disorder or pulmonary disorder, severe intercurrent systemic disease, or any other disease that interferes with the assessments
4. Treatment with interferon ß, glatiramer acetate, plasmapheresis, other immunomodulatory drugs, or immunosuppressive drugs including azathioprine, cyclophosphamide and methotrexate, within 6 months of week 0
5. Treatment with systemic corticosteroids in the 30 days prior to week 4, or between week 4 and week 0
6. Women of childbearing potential, who are not using a medically accepted safe method of contraception (medically acceptable safe methods of contraception for the purposes of this study will include surgical sterilisation, oral or depot contraceptives [taken for at least 60 day before week 0], intrauterine devices, diaphragm with spermicidal; other methods i.e. sexual abstinence may be considered by the Investigator as appropriate contraception on a patient-by-patient basis)
7. Pregnancy or women who are lactating
8. Moderate to severe depression measured as a score greater than 18 on the Beck Depression Inventory
9. Bipolar disorder
10. Treatment with antidepressant medications (selective serotonin reuptake inhibitors [SSRI], tricyclic antidepressant [TCA], other) and/or lithium

Study & Design

• Study Type: Interventional
• Study Design: Not specified