Multiple Sclerosis, Relapsing, RemittingPhase 4SEPTIMENCT01201343

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

A Phase 4 study testing Interferon beta-1a in people with Multiple Sclerosis, Relapsing, Remitting, run by Merck KGaA, Darmstadt, Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Sclerosis, Relapsing, Remitting
What is being tested?: Interferon beta-1a
How many people: 79 participants
Where: No sites listed yet
Study dates: Jan 2005to Jul 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

Read the 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).

Conditions: Multiple Sclerosis, Relapsing, Remitting
Being tested: Interferon beta-1a
Keywords: Multiple sclerosis, relapsing, remitting, Interferon-beta
Medical subject headings: Multiple Sclerosis, Relapsing-Remitting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Interferon beta-1aDrug
Also called Rebif

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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)
Measured: 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)
Measured: 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
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)
Measured: 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
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)
Measured: 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
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)
Measured: 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
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)
Measured: 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
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)
Measured: Baseline, Months 1, 2, 3, 6, 12, and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2005Jul 2010

First posted14 Sep 2010 (estimated)
Study startJan 2005
Primary completionJul 2010
Study completionJul 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Multiple Sclerosis, Relapsing, RemittingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01201343
Sponsor's protocol ID: IMP 25206
Acronym: SEPTIME
Status last verified: Dec 2013
First submitted: 13 Sep 2010
Last updated: 27 Dec 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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. doi: 10.1016/s0013-7006(07)91558-4. French.
PubMed 17457294
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.
PubMed 10467380
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Emotional Disorders During Treatment by Interferon Beta in Relapsing-remitting Multiple Sclerosis Patients
ClinicalTrials.gov ID: NCT01201343
Acronym / sponsor ID: SEPTIME / IMP 25206
Conditions: Multiple Sclerosis, Relapsing, Remitting
Keywords: Multiple sclerosis, relapsing, remitting, Interferon-beta
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 79 participants (actual)
Lead sponsor: Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
Collaborators: Merck Serono S.A.S, France
Study start: Jan 2005
Primary completion: Jul 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 14 Sep 2010 (estimated)
Results: Posted 11 Apr 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Interferon beta-1aAlso: Rebif	Drug	–

Primary outcome

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)
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)
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)

5 secondary outcomes

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
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
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
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
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

Results and safety

Results posted to the registry on 11 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Interferon-beta	79	60

Primary outcome: 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. Mean (Standard Deviation). Unit: units on a scale

Measure	Interferon-beta n = 70
Baseline (n= 70)	12.7 (4.4)
Change at Month 12 (n= 57)	-0.5 (4.2)

Population analysed: Intent-to-treat (ITT) population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'n' signifies those participants who were evaluated for this measure at that time point.

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

Time frame: Baseline and Month 18. Mean (Standard Deviation). Unit: units on a scale

Measure	Interferon-beta n = 61
Value	-0.6 (4.6)

Population analysed: ITT population: all participants with at least 1 interferon-beta intake and 1 evaluation of primary criterion, that is, at least 1 evaluation before treatment initiation and after Day 0 for emotional dyscontrol sub-score. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure at that time-point.

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

Time frame: Baseline and Month 24. Mean (Standard Deviation). Unit: units on a scale

Measure	Interferon-beta n = 63
Value	-0.1 (5.2)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to Month 24. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Interferon-beta	9 of 76 (11.8%)	62 of 76 (81.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17457294Radat 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.
Background: PubMed 10467380Sharrack 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.
BackgroundSpielberger, 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
BackgroundRadloff LS. The CES-D scale: A self-report depression scale for research in the general population. Applied Psychological Measurement. 1977;1:385-401.
BackgroundSpielberger CD. Manual for the State-Anger Expression Inventory. Odessa, FL: Psychological Assessment Resources; 1996

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bruno Brochet, MD, Prof. principal investigator

Hôpital PELLEGRIN, Place Amélie Raba Léon 33076 BORDEAUX Cedex

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Interferon beta-1a in people with Multiple Sclerosis, Relapsing, Remitting, run by Merck KGaA, Darmstadt, Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01201343, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2013.