Fluoxetine therapy in Multiple Sclerosis. A double blind, randomised, placebo-controlled, phase II study in patients with relapsing Multiple Sclerosis.

• Register: Netherlands Trial Register
• Last refreshed on: 27 May 2013
• Main ID: NTR415
• Date of registration: 15/09/2005
• Primary sponsor: University Medical Center Groningen (UMCG)
• Public title: Fluoxetine therapy in Multiple Sclerosis. A double blind, randomised, placebo-controlled, phase II study in patients with relapsing Multiple Sclerosis.
• Scientific title: Fluoxetine therapy in Multiple Sclerosis. A double blind, randomised, placebo-controlled, phase II study in patients with relapsing Multiple Sclerosis. - N/A
• Date of first enrolment: 1/1/2004
• Target sample size: 40
• Recruitment status: complete
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=415
• Study type: intervention
• Study design: Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: J.P. Mostert

• Name: J.P. Mostert

Key inclusion & exclusion criteria

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 relasping secondary progressive MS, as defined by the Lublin Criteria;

5. At least one documented clinical or subclinical (defined as a gadolinium enhanced lesion on MRI examination) exacerbation in the last year
or 2 documented exacerbation?s 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 > 18 on the Beck Depression Inventory;

9. Bipolar disorder;

10. Treatment with antidepressant medications (SSRI, TCA, other) and/or lithium.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Multiple sclerosis (MS)

Intervention(s)

Fluoxetine capsule 20 mg/ day orally versus placebo. Medication is taken from week 0 to 24.

MRI scans are performed at week -4, 0, 4, 8, 16 and 24.

EDSS, MSFC and questionnaires are assessed at week 0 and 24.

Primary Outcome(s)

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

Secondary Outcome(s)

1. Difference between Week 0 and Week 24 in:

a. Tthe change in lesion volume on T2 weighted MRI;

b. 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 (SF 36) between Week 0 and Week 24
The MSFC comprises quantitative functional measures of three key clinical dimensions of MS: leg function/ambulation (Timed 25-Foot Walk), arm function (Nine-Hole Peg Test), and cognitive function (Paced Auditory Serial Addition Test [PASAT]). Scores on component measures are converted to standard scores (z-scores), which are averaged to form a single MSFC score.

Secondary ID(s)

ISRCTN65586975

N/A

Source(s) of Monetary Support

Innovatiefonds University Medical Center Groningen