Clinical trial NCT01201343: Evaluation of Emotional Disorders During Treatment by Interferon Beta in Relapsing-remitting Multiple Sclerosis Patients
Official title: Evaluation of Emotional Disorders During Treatment by Interferon Beta in Relapsing-remitting Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis, Relapsing, Remitting
Keywords: Multiple sclerosis, relapsing, remitting
Interferon-beta
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck Serono S.A.S, France
First posted: 2010-09-14
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Emotional Dyscontrol Sub-score of the Depressive Mood Scale (Echelle d'Humeur Depressive [EHD]) Scale at Month 12
timeFrame: Baseline and Month 12
measure: Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 18
timeFrame: Baseline and Month 18
measure: Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 24
timeFrame: Baseline and Month 24
Secondary outcomes:
measure: Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
measure: Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
measure: Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
measure: Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24
measure: Change From Baseline in Fatigue Score at Months 1, 2, 3, 6, 12 and 24
timeFrame: Baseline, Months 1, 2, 3, 6, 12, and 24
Other outcomes:
Locations:
Study officials:
affiliation: Hôpital PELLEGRIN, Place Amélie Raba Léon 33076 BORDEAUX Cedex
name: Bruno Brochet, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Radat F, Lafittau M, Ouallet JC, Brochet B, Jouvent R. [Validation of EHD self questionnaire in multiple sclerosis]. Encephale. 2007 Jan-Feb;33(1):49-57. doi: 10.1016/s0013-7006(07)91558-4. French.
citation: Sharrack B, Hughes RA. The Guy's Neurological Disability Scale (GNDS): a new disability measure for multiple sclerosis. Mult Scler. 1999 Aug;5(4):223-33. doi: 10.1177/135245859900500406.
citation: Spielberger, C. D., Gorsuch, R. L., Lushene, R., Vagg, P. R., & Jacobs, G. A. (1983). Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press
citation: Radloff LS. The CES-D scale: A self-report depression scale for research in the general population. Applied Psychological Measurement. 1977;1:385-401.
citation: Spielberger CD. Manual for the State-Anger Expression Inventory. Odessa, FL: Psychological Assessment Resources; 1996