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

NCT ID: NCT01201343

Last Updated: 2013-12-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2010-07-31

Brief Summary

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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

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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).

Conditions

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Multiple Sclerosis, Relapsing, Remitting

Keywords

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Multiple sclerosis, relapsing, remitting Interferon-beta

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Interferon beta-1a

Intervention Type DRUG

Other Intervention Names

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Rebif

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Serono S.A.S, France

INDUSTRY

Sponsor Role collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruno Brochet, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

Hôpital PELLEGRIN, Place Amélie Raba Léon 33076 BORDEAUX Cedex

References

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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.

Reference Type BACKGROUND
PMID: 17457294 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10467380 (View on PubMed)

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND

Other Identifiers

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IMP 25206

Identifier Type: -

Identifier Source: org_study_id