Contact information
Type
Scientific
Primary contact
Dr J.P. Mostert
ORCID ID
Contact details
University Medical Center Groningen (UMCG)
P.O. Box 30001
Groningen
9700 RB
Netherlands
+31 (0)50 3614817 / +31 (0)50 3612430
j.p.mostert@neuro.umcg.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Fluoxetine has in animals and cell cultures neuroprotective properties. We test whether fluoxetine is able to reduce progression in patients with Multiple Sclerosis (MS).
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Placebo controlled, randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Multiple Sclerosis (MS)
Intervention
1. Treatment with fluoxetine 40 mg/day or placebo during two years
2. Every three months clinical evaluation (EDSS, Multiple Sclerosis Functional Composite [MSFC], Ambulatory Index [AI])
3. Yearly cerebral MRI
4. Yearly questionnaires (Guys Neurological Disability Scale, BDI, Short Form [SF-36] health survey)
Intervention type
Drug
Phase
Not Specified
Drug names
Fluoxetine
Primary outcome measure
Number of patients with progression in two years. Progression is defined as:
1. Persistent (two or more follow-up assessments) worsening of EDSS with 1.0 point with basis EDSS 3.0 to 5.0 or persistent (two or more follow-up assessments) worsening of EDSS with 0.5 with basis EDSS 5.5 to 6.5
2. Or persistent (two or more follow-up assessments) worsening of 9-Hole Peg Test (9-HPT) with 20% compared to baseline measurement
3. Or persistent (two or more follow-up assessments) worsening of the AI of one point with a basis AI between two and six
Secondary outcome measures
1. Change in the following MRI measurements:
a. T2 lesion volume
b. T1 lesion volume (black holes)
c. Brain atrophy
d. N-Acetyl Aspartate (NAA)
e. Apparent Diffusion Co-efficient (ADC) and Fractional
Anisotropy (FA) histogram values
2. Change in EDSS, MSFC, SF-36, Guys Neurological Disability Scale, BDI, Family Intrusiveness Scale (FIS)
3. Time (in months) to progression
Overall trial start date
01/05/2006
Overall trial end date
01/05/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Written informed consent
2. Age 18 to 65
3. MS according to the McDonald criteria or primary progressive MS according to the Thompson criteria
4. Expanded Disability Status Scale (EDSS) 3.0 to 6.5 inclusive
5. Documented progression in the last two years unrelated to clinical exacerbations in the last two years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Contra-indication Magnetic Resonance Imaging (MRI) (e.g., metal, claustrophobia)
2. Women of childbearing potential, who are not using a medically accepted safe method of contraception
3. Pregnancy or women who are lactating
4. Moderate to severe depression measured as a score of more than 18 on the Beck Depression Inventory (BDI)
5. Treatment with Selective Serotonin Reuptake Inhibitors (SSRI's)
6. Treatment with Monoamine Oxidase (MAO)-inhibitors, oral anticoagulantia, Serotonin (5-HT) agonists and/or lithium
7. Treatment with interferon ß, glatiramer acetate, plasmapheresis, natalizumab, other immunomodulatory drugs, or immunosuppressive drugs including azathioprine, cyclophosphamide and methotrexate, within six months of week zero
8. Treatment with corticosteroids within three months of week zero
9. Renal failure
10. 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
Recruitment start date
01/05/2006
Recruitment end date
01/05/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Groningen (UMCG)
Groningen
9700 RB
Netherlands
Funders
Funder type
Hospital/treatment centre
Funder name
Innovatiefonds University Medical Center Groningen (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list