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

Sponsor

Merck KGaA, Darmstadt, Germany (Industry)

Overall Status

Completed

CT.gov ID

NCT01201343

Collaborator

Merck Serono S.A.S, France (Industry)

Enrollment

65.9

Duration (Months)

Study Details

Study Description

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

Study Type:

Interventional

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 :

Jan 1, 2005

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Jul 1, 2010

Outcome Measures

Primary Outcome Measures

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

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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

No locations specified.

Sponsors and Collaborators

Merck KGaA, Darmstadt, Germany
Merck Serono S.A.S, France

Investigators

Principal Investigator: Bruno Brochet, MD, Prof., Hôpital PELLEGRIN, Place Amélie Raba Léon 33076 BORDEAUX Cedex

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Merck KGaA, Darmstadt, Germany

ClinicalTrials.gov Identifier:

NCT01201343

Other Study ID Numbers:

IMP 25206

First Posted:

Sep 14, 2010

Last Update Posted:

Dec 27, 2013

Last Verified:

Dec 1, 2013

Keywords provided by Merck KGaA, Darmstadt, Germany

Multiple sclerosis, relapsing, remitting

Interferon-beta

Additional relevant MeSH terms:

Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail

Arm/Group Title	Interferon-beta
Arm/Group Description	Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
Period Title: Overall Study
STARTED	79
Treated	76
COMPLETED	60
NOT COMPLETED	19

Baseline Characteristics

Arm/Group Title	Interferon-beta
Arm/Group Description	Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
Overall Participants	70
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.0 (11.5)
Sex: Female, Male (Count of Participants)
Female	56 80%
Male	14 20%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	Interferon-beta
Arm/Group Description	Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
Measure Participants	70
Baseline (n= 70)	12.7 (4.4)
Change at Month 12 (n= 57)	-0.5 (4.2)

2. Primary Outcome

Title	Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 18
Description	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)
Time Frame	Baseline and Month 18

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	Interferon-beta
Arm/Group Description	Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
Measure Participants	61
Mean (Standard Deviation) [units on a scale]	-0.6 (4.6)

3. Primary Outcome

Title	Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 24
Description	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)
Time Frame	Baseline and Month 24

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	Interferon-beta
Arm/Group Description	Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
Measure Participants	63
Mean (Standard Deviation) [units on a scale]	-0.1 (5.2)

4. Secondary Outcome

Title	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
Description	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)
Time Frame	Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	Interferon-beta
Arm/Group Description	Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
Measure Participants	70
Baseline (n= 70)	5.6 (1.6)
Change at Month 1 (n= 64)	0.3 (1.6)
Change at Month 2 (n= 62)	-0.1 (1.7)
Change at Month 3 (n= 64)	-0.0 (1.6)
Change at Month 4 (n= 59)	-0.0 (1.8)
Change at Month 5 (n= 58)	-0.2 (1.5)
Change at Month 6 (n= 56)	-0.3 (1.8)
Change at Month 9 (n= 58)	-0.1 (1.8)
Change at Month 12 (n= 57)	-0.0 (2.3)
Change at Month 18 (n= 61)	-0.3 (1.9)
Change at Month 24 (n= 63)	-0.3 (1.7)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	Interferon-beta
Arm/Group Description	Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
Measure Participants	70
Baseline (n= 70)	35.9 (11.8)
Change at Month 1 (n= 65)	0.8 (10.5)
Change at Month 2 (n= 62)	0.3 (12.3)
Change at Month 3 (n= 64)	-1.7 (11.5)
Change at Month 4 (n= 59)	-1.5 (11.0)
Change at Month 5 (n= 58)	-0.8 (9.2)
Change at Month 6 (n= 55)	-1.4 (11.5)
Change at Month 9 (n= 58)	-0.2 (10.5)
Change at Month 12 (n= 57)	-0.3 (12.7)
Change at Month 18 (n= 61)	-1.2 (11.2)
Change at Month 24 (n= 63)	-1.4 (13.1)

6. Secondary Outcome

Title	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
Description	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)
Time Frame	Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	Interferon-beta
Arm/Group Description	Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
Measure Participants	70
Baseline (n= 70)	13.5 (11.1)
Change at Month 1 (n= 65)	1.0 (8.6)
Change at Month 2 (n= 62)	1.5 (10.6)
Change at Month 3 (n= 64)	-0.5 (9.9)
Change at Month 4 (n= 58)	-1.0 (9.8)
Change at Month 5 (n= 58)	-1.1 (8.6)
Change at Month 6 (n= 56)	0.9 (9.2)
Change at Month 9 (n= 58)	0.9 (10.7)
Change at Month 12 (n= 57)	1.6 (10.8)
Change at Month 18 (n= 61)	-0.2 (9.0)
Change at Month 24 (n= 63)	0.1 (10.1)

7. Secondary Outcome

Title	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
Description	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)
Time Frame	Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24

Outcome Measure Data

Analysis Population Description
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.

Arm/Group Title	Interferon-beta
Arm/Group Description	Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
Measure Participants	70
Baseline (n= 70)	16.8 (4.1)
Change at Month 1 (n= 65)	0.0 (4.2)
Change at Month 2 (n= 62)	1.0 (5.3)
Change at Month 3 (n= 64)	-0.0 (5.3)
Change at Month 4 (n= 59)	-0.3 (4.7)
Change at Month 5 (n= 58)	-0.0 (2.9)
Change at Month 6 (n= 56)	1.1 (7.6)
Change at Month 9 (n= 58)	1.1 (5.9)
Change at Month 12 (n= 57)	0.9 (5.7)
Change at Month 18 (n= 61)	0.8 (5.4)
Change at Month 24 (n= 63)	1.0 (5.5)

8. Secondary Outcome

Title	Change From Baseline in Fatigue Score at Months 1, 2, 3, 6, 12 and 24
Description	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)
Time Frame	Baseline, Months 1, 2, 3, 6, 12, and 24

Outcome Measure Data

Analysis Population Description
ITT population. 'N' (number of participants analyzed) signifies those participants who were evaluated for this measure. 'n' signifies those participants who were evaluated for this measure at that time point.

Arm/Group Title	Interferon-beta
Arm/Group Description	Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
Measure Participants	62
Baseline (n= 62)	2.1 (1.7)
Change at Month 1 (n= 58)	0.5 (1.6)
Change at Month 2 (n= 55)	0.4 (1.5)
Change at Month 3 (n= 56)	0.2 (1.8)
Change at Month 6 (n= 50)	0.4 (1.8)
Change at Month 12 (n= 49)	0.1 (1.8)
Change at Month 24 (n= 56)	-0.1 (2.1)

Adverse Events

	Interferon-beta
Time Frame	Baseline to Month 24
Adverse Event Reporting Description	An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.

Arm/Group Title	Interferon-beta
Arm/Group Description	Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
All Cause Mortality
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Interferon-beta
	Affected / at Risk (%)	# Events
Total	9/76 (11.8%)
Ear and labyrinth disorders
Sudden Hearing Loss	1/76 (1.3%)	1
Injury, poisoning and procedural complications
Neck Injury	1/76 (1.3%)	1
Nervous system disorders
Headache	1/76 (1.3%)	1
Pregnancy, puerperium and perinatal conditions
Abortion	1/76 (1.3%)	1
Psychiatric disorders
Depression	3/76 (3.9%)	3
Anxiety	1/76 (1.3%)	1
Drug Dependence	1/76 (1.3%)	1
Aggressivity	1/76 (1.3%)	1
Suicide Attempt	1/76 (1.3%)	1
Respiratory, thoracic and mediastinal disorders
Lung Disorder	1/76 (1.3%)	1
Pleurisy	1/76 (1.3%)	1
Other (Not Including Serious) Adverse Events
	Interferon-beta
	Affected / at Risk (%)	# Events
Total	62/76 (81.6%)
Blood and lymphatic system disorders
Lymphopenia	2/76 (2.6%)	2
Leukopenia	1/76 (1.3%)	1
Lymphadenitis	1/76 (1.3%)	1
Lymphadenopathy	1/76 (1.3%)	1
Neutropenia	1/76 (1.3%)	1
Thrombocytopenia	1/76 (1.3%)	1
Ear and labyrinth disorders
Deafness	1/76 (1.3%)	1
Menlere's Disease	1/76 (1.3%)	1
Vertigo	1/76 (1.3%)	1
Endocrine disorders
Hypothyroidism	1/76 (1.3%)	1
Gastrointestinal disorders
Constipation	2/76 (2.6%)	2
Abdominal Pain	1/76 (1.3%)	1
Abdominal Pain Upper	1/76 (1.3%)	1
Faecal Incontinence	1/76 (1.3%)	1
Vomiting	1/76 (1.3%)	1
General disorders
Influenza Like Illness	18/76 (23.7%)	18
Fatigue	11/76 (14.5%)	11
Injection Site Pain	7/76 (9.2%)	7
Injection Site Erythema	5/76 (6.6%)	5
Irritability	2/76 (2.6%)	2
Injection Site Haematoma	1/76 (1.3%)	1
Injection Site Reaction	1/76 (1.3%)	1
Pain	1/76 (1.3%)	1
Hepatobiliary disorders
Cytolytic Hepatitis	3/76 (3.9%)	3
Hepatitis	1/76 (1.3%)	1
Infections and infestations
Bronchitis	2/76 (2.6%)	2
Influenza	2/76 (2.6%)	2
Tonsillitis	2/76 (2.6%)	2
Urinary Tract Infection	2/76 (2.6%)	2
Acarodermatitis	1/76 (1.3%)	1
Nasopharyngitis	1/76 (1.3%)	1
Rhinolaryngitis	1/76 (1.3%)	1
Tracheitis	1/76 (1.3%)	1
Urinary Tract Infection ba	1/76 (1.3%)	1
Injury, poisoning and procedural complications
Ankle Fracture	1/76 (1.3%)	1
Clavicle Fracture	1/76 (1.3%)	1
Joint Dislocation	1/76 (1.3%)	1
Procedural Headache	1/76 (1.3%)	1
Upper Limb Fracture	1/76 (1.3%)	1
Wrist Fracture	1/76 (1.3%)	1
Investigations
Gamma-glutamyltransferase	1/76 (1.3%)	1
Liver Function Test Abnormal	1/76 (1.3%)	1
Musculoskeletal and connective tissue disorders
Pain in Extremity	4/76 (5.3%)	4
Arthralgia	1/76 (1.3%)	1
Back Pain	1/76 (1.3%)	1
Myalgia	1/76 (1.3%)	1
Tendon Disorder	1/76 (1.3%)	1
Tendonitis	1/76 (1.3%)	1
Nervous system disorders
Headache	2/76 (2.6%)	2
Multiple Sclerosis Relapse	40/76 (52.6%)	40
Migraine	2/76 (2.6%)	2
Carpal Tunnel Syndrome	1/76 (1.3%)	1
Neuralgia	1/76 (1.3%)	1
Nystagmus	1/76 (1.3%)	1
Paraesthesia	1/76 (1.3%)	1
Restless Legs Syndrome	1/76 (1.3%)	1
Sciatica	1/76 (1.3%)	1
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous	1/76 (1.3%)	1
Pregnancy	1/76 (1.3%)	1
Psychiatric disorders
Depression	6/76 (7.9%)	6
Anxiety	2/76 (2.6%)	2
Insomnia	2/76 (2.6%)	2
Depressed Mood	1/76 (1.3%)	1
Emotional Distress	1/76 (1.3%)	1
Mania	1/76 (1.3%)	1
Panic Attack	1/76 (1.3%)	1
Sleep Disorder	1/76 (1.3%)	1
Respiratory, thoracic and mediastinal disorders
Haemoptysis	1/76 (1.3%)	1
Skin and subcutaneous tissue disorders
Erythema	2/76 (2.6%)	2
Rash	1/76 (1.3%)	1
Vascular disorders
Raynaud's Phenomenon	1/76 (1.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Results Point of Contact

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

Responsible Party:

Merck KGaA, Darmstadt, Germany

ClinicalTrials.gov Identifier:

NCT01201343

Other Study ID Numbers:

IMP 25206

First Posted:

Sep 14, 2010

Last Update Posted:

Dec 27, 2013

Last Verified:

Dec 1, 2013

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

Study Details

Study Description

Brief Summary

Detailed Description

Study Design

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

More Information

Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

More Information

Certain Agreements

Results Point of Contact