Evaluation of Emotional Disorders During Treatment by Interferon Beta in Relapsing-remitting Multiple Sclerosis Patients

Evaluation of Emotional Disorders During Treatment by Interferon Beta in Relapsing-remitting Multiple Sclerosis Patients

This study is planned to evaluate emotional disorders during treatment by interferon (IFN) beta in relapsing remitting multiple sclerosis (RRMS) subjects. This is an open-label exploratory study with no change of therapeutic behavior but with standardized neuropsychologic follow-up.

This study is planned to evaluate emotional disorders during treatment by IFN beta in RRMS subjects. This is an open-label, prospective, interventional, multicentric study with no change of therapeutic behavior but with standardized neuropsychologic follow-up. Subjects will undergo 13 evaluations (categorical and dimensional evaluations), 3 evaluations will be performed before the treatment (Baseline, Day 7 and 15) and 10 evaluations after the treatment (Month 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24).

Inclusion Criteria:

• Male and female subjects aged ≥ 18 years
• Subjects with RRMS
• Subjects with at least 2 relapses in the past two years (with last relapse finished or finishing)
• Subjects with indication of IFN beta treatment determined by the investigator
• Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

• Subjects with secondary progressive multiple sclerosis (MS) without relapse
• Subjects with ongoing acute relapse
• Subjects already being treated with interferon
• Subjects with corticoid therapy for less than 15 days
• Subjects presenting acute major depression or treated with anti-depressant therapy
• Subjects involved in another therapeutic study
• Subjects with any condition which could interfere with a good compliance of this study
• Other protocol-defined exclusion criteria may apply