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

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ClinicalTrials.gov Identifier: NCT01201343
Recruitment Status : Completed
First Posted : September 14, 2010
Results First Posted : April 11, 2012
Last Update Posted : December 27, 2013
Sponsor:
Collaborator:
Merck Serono S.A.S, France
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Study Description
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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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing, Remitting Drug: Interferon beta-1a Phase 4

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Emotional Disorders During Treatment by Interferon Beta in Relapsing-remitting Multiple Sclerosis Patients
Study Start Date : January 2005
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

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Arms and Interventions
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Intervention Details:
  • Drug: Interferon beta-1a
    Other Name: Rebif

Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Emotional Dyscontrol Sub-score of the Depressive Mood Scale (Echelle d'Humeur Depressive [EHD]) Scale at Month 12 [ Time Frame: Baseline and 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)

  2. Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 18 [ Time Frame: Baseline and 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)

  3. Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 24 [ Time Frame: Baseline and 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)


Secondary Outcome Measures :
  1. 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 [ Time Frame: Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 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 abrasion sub-score is the sum of items 3, 6, 7, and 8. The total possible score range from 1 (not at all) to 16 (very much), where 16 corresponds to worst state. (Radat F et al., 2007)

  2. Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 [ Time Frame: Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 ]
    STAI state scale is an auto-evaluation scale for anxiety. This scale includes 20 items that allow quantifying feeling of apprehension, tension, nervousness and worry that the participant feels at the time of the completion of the questionnaire. The 20 items are graded from 1 (no) to 4 (yes), where 'yes' corresponds to the best state for items 1, 2, 5, 8, 10, 11, 15, 16, 19, 20 (scoring was reversed before calculation of total score); and to the worst state for items 3, 4, 6, 7, 9, 12, 13, 14, 17, 18. The total score ranged from 1 (best state) to 80 (worst state). (Spielberger CD et al., 1983)

  3. 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 [ Time Frame: Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 ]
    CES-D is an auto-questionnaire including 20 items to screen for depressive feelings and behaviour. The 20 items of this scale are graded from 0 (never) to 3 (always), where 3 corresponds to the most severe state with the exception of items 4, 8, 12 and 16 (scoring was reversed before the calculation of the total score). Total score ranged from 0 (never) to 60 (always), where 60 corresponds to most severe state. (Radloff LS, 1977)

  4. 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 [ Time Frame: Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 ]
    STAXI-state scale measures the intensity of anger as an emotional state (state anger) and the disposition to experience angry feelings as a personality trait (trait anger). In this study only 1 of the original 6 scales was used, the state anger scale, which measures the intensity of anger at a given moment as emotional state. This scale consists of 15 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The total score range from 1 (not at all) to 60 (very much), where 60 corresponds to the worst state. (Spielberger CD, 1996)

  5. Change From Baseline in Fatigue Score at Months 1, 2, 3, 6, 12 and 24 [ Time Frame: Baseline, Months 1, 2, 3, 6, 12, and 24 ]
    Fatigue scale was derived from the United Kingdom Neurological Disability Scale (UKNDS), and evaluates fatigue according to the participant's subjective impression and the functional disability that it causes. 'Yes' or 'No' answers result in a score that ranges from 0 to 5, where a score 5 shows worse state. (Sharrack B et al., 1999)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01201343


Sponsors and Collaborators
Merck KGaA, Darmstadt, Germany
Merck Serono S.A.S, France
Investigators
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Principal Investigator: Bruno Brochet, MD, Prof. Hôpital PELLEGRIN, Place Amélie Raba Léon 33076 BORDEAUX Cedex
More Information
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Publications:
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

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Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01201343    
Other Study ID Numbers: IMP 25206
First Posted: September 14, 2010    Key Record Dates
Results First Posted: April 11, 2012
Last Update Posted: December 27, 2013
Last Verified: December 2013
Keywords provided by Merck KGaA, Darmstadt, Germany:
Multiple sclerosis, relapsing, remitting
Interferon-beta
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
 Interferons
Interferon-beta
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic