NCT01201343

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2010

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

April 11, 2012

Completed
Last Updated

December 27, 2013

Status Verified

December 1, 2013

Enrollment Period

5.5 years

First QC Date

September 13, 2010

Results QC Date

March 15, 2012

Last Update Submit

December 2, 2013

Conditions

Multiple Sclerosis, Relapsing, Remitting

Keywords

Multiple sclerosis, relapsing, remittingInterferon-beta

Outcome Measures

Primary Outcomes (3)

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

    EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007)

    Baseline and Month 12

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

    EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007)

    Baseline and Month 18

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

    EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007)

    Baseline and Month 24

Secondary Outcomes (5)

  • 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

    Baseline, 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

    Baseline, 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

    Baseline, 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

    Baseline, 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

    Baseline, Months 1, 2, 3, 6, 12, and 24

Interventions

Interferon beta-1aDRUG
Also known as: Rebif

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 17457294BACKGROUND

  • 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.

    PMID: 10467380BACKGROUND

  • 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

    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.

    BACKGROUND

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

    BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Results Point of Contact

Title
Merck KGaA Communication Center
Organization
Merck Serono, a division of Merck KGaA
service@merckgroup.com
+49-6151-72-5200

Study Officials

  • Bruno Brochet, MD, Prof.

    Hôpital PELLEGRIN, Place Amélie Raba Léon 33076 BORDEAUX Cedex

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2010

First Posted

September 14, 2010

Study Start

January 1, 2005

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

December 27, 2013

Results First Posted

April 11, 2012

Record last verified: 2013-12