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

Information source: Merck KGaA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis, Relapsing, Remitting

Intervention: Interferon beta-1a (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Merck KGaA

Official(s) and/or principal investigator(s):
Bruno Brochet, MD, Prof., Principal Investigator, Affiliation: Hôpital PELLEGRIN, Place Amélie Raba Léon 33076 BORDEAUX Cedex

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.

Clinical Details

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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Change From Baseline in Emotional Dyscontrol Sub-score of the Depressive Mood Scale (Echelle d'Humeur Depressive [EHD]) Scale at Month 12

Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 18

Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 24

Secondary outcome:

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

Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24

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

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

Change From Baseline in Fatigue Score at Months 1, 2, 3, 6, 12 and 24

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

Related publications:

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. French.

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.

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

Radloff LS. The CES-D scale: A self-report depression scale for research in the general population. Applied Psychological Measurement. 1977;1:385-401.

Spielberger CD. Manual for the State-Anger Expression Inventory. Odessa, FL: Psychological Assessment Resources; 1996

Starting date: January 2005
Last updated: December 2, 2013

Page last updated: August 23, 2015

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