Fluoxetine therapy in multiple sclerosis: a double blind, randomised,

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

Completed (inferred)Phase 2Relapsing and progressiveISRCTN65586975

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Fluoxetine

What it measured

Main measures

  • Difference between week 0 and week 24 in the cumulative number of active lesions on MRI scans.

    MRI lesions

Other measures (1)

  • 1. Difference between Week 0 and Week 24 in: 1.1. The change in lesion volume on T2 weighted MRI 1.2. The change in gadolinium-enhanced lesion volume on Tl weighted MRI 2. Difference in the number of MS exacerbations over the 24-week period 3. Difference in the change in EDDS, Multiple Sclerosis Functional Composite (MSFC), fatigue severity scale, and QoL (36-item short form health survey [SF-36

    Disability progressionMRI lesionsThinking and memoryFatigueWalking and mobilityArm and hand functionQuality of life (reported by participants)

Who could take part

Relapsing and progressive · 18 and over · EDSS 0.0 to 6.0

Show the full criteria

Inclusion criteria

Inclusion: 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: 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

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Not provided at time of registration

Papers

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Related trials

History

    1. Started

      Jan 2004

    2. Finished

      Jul 2006

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