Fluoxetine therapy for multiple sclerosis

Conditions: progressive multiple sclerosis
MedDRA version: 16.0Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 16.0Level: PTClassification code 10063400Term: Secondary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 16.0Level: PTClassification code 10053395Term: Progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2011-003775-11-BE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 120

Inclusion Criteria

1.Signed written informed consent.
2.Either secondary or primary progressive MS.
3.Age 25-65 years.
4.EDSS at baseline of 3 – 6.5 points inclusive.
5.Disability increased in the preceding year because of steady disease progression.
6.Ability to be compliant with the schedule of protocol assessments.
7.For sexually active female patients with reproductive potential, use of reliable means of contraception.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Pregnancy or lactation
2.Allergy to fluoxetine
3.Use of fluoxetine
4.Use of other antidepressants, unless they can be stopped for 2 months before starting with the study medication.
5.Contraindication for MRI (relative exclusion criterion because patients who have a contraindication are allowed to participate).
6.Major depression following the DSM-IV
7.Other neurologic, serious psychiatric or systemic disorders that could interfere with the assessments.
8.Use of immunomodulatory or immunosuppressive drugs, except for interferon’s 1a and 1 b or glatiramer (as it has been shown hat these are ineffective in slowing down progression). Patients using other immune drugs can be included if these treatments are stopped before randomization.
9.Participation in another clinical trial
10.Concomitant use of drugs that can cause a serotonin syndrome unless they can be stopped before randomization.