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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 Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Sclerosis, Relapsing, Remitting
Intervention Drug: Interferon beta-1a
Enrollment 79
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Interferon-beta
Hide 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
Reason Not Completed
Adverse Event             6
Withdrawal by Subject             5
Lost to Follow-up             2
Lack of Efficacy             2
Participant wrongly included in trial             1
Randomized, not treated             3
Arm/Group Title Interferon-beta
Hide Arm/Group Description Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
Overall Number of Baseline Participants 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 70 participants
37.0  (11.5)
[1]
Measure Description: Out of a total of 79 participants, data for baseline measure (age) was available for 70 participants with at least one interferon-beta intake and with at least one evaluation of the primary criterion.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants
Female
56
  80.0%
Male
14
  20.0%
[1]
Measure Description: Out of a total of 79 participants, data for baseline measure (gender) was available for 70 participants with at least one interferon-beta intake and with at least one evaluation of the primary criterion.
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
Overall Number of Participants Analyzed 70
Mean (Standard Deviation)
Unit of Measure: units on a scale
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
Overall Number of Participants Analyzed 61
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
Overall Number of Participants Analyzed 63
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
Overall Number of Participants Analyzed 70
Mean (Standard Deviation)
Unit of Measure: units on a scale
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
Overall Number of Participants Analyzed 70
Mean (Standard Deviation)
Unit of Measure: units on a scale
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
Overall Number of Participants Analyzed 70
Mean (Standard Deviation)
Unit of Measure: units on a scale
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
Overall Number of Participants Analyzed 70
Mean (Standard Deviation)
Unit of Measure: units on a scale
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
Overall Number of Participants Analyzed 62
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
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
Hide Arm/Group Description Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
All-Cause Mortality
Interferon-beta
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Interferon-beta
Affected / at Risk (%) # Events
Total   9/76 (11.84%)    
Ear and labyrinth disorders   
Sudden Hearing Loss * 1  1/76 (1.32%)  1
Injury, poisoning and procedural complications   
Neck Injury * 1  1/76 (1.32%)  1
Nervous system disorders   
Headache * 1  1/76 (1.32%)  1
Pregnancy, puerperium and perinatal conditions   
Abortion * 1  1/76 (1.32%)  1
Psychiatric disorders   
Depression * 1  3/76 (3.95%)  3
Anxiety * 1  1/76 (1.32%)  1
Drug Dependence * 1  1/76 (1.32%)  1
Aggressivity * 1  1/76 (1.32%)  1
Suicide Attempt * 1  1/76 (1.32%)  1
Respiratory, thoracic and mediastinal disorders   
Lung Disorder * 1  1/76 (1.32%)  1
Pleurisy * 1  1/76 (1.32%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Interferon-beta
Affected / at Risk (%) # Events
Total   62/76 (81.58%)    
Blood and lymphatic system disorders   
Lymphopenia * 1  2/76 (2.63%)  2
Leukopenia * 1  1/76 (1.32%)  1
Lymphadenitis * 1  1/76 (1.32%)  1
Lymphadenopathy * 1  1/76 (1.32%)  1
Neutropenia * 1  1/76 (1.32%)  1
Thrombocytopenia * 1  1/76 (1.32%)  1
Ear and labyrinth disorders   
Deafness * 1  1/76 (1.32%)  1
Menlere's Disease * 1  1/76 (1.32%)  1
Vertigo * 1  1/76 (1.32%)  1
Endocrine disorders   
Hypothyroidism * 1  1/76 (1.32%)  1
Gastrointestinal disorders   
Constipation * 1  2/76 (2.63%)  2
Abdominal Pain * 1  1/76 (1.32%)  1
Abdominal Pain Upper * 1  1/76 (1.32%)  1
Faecal Incontinence * 1  1/76 (1.32%)  1
Vomiting * 1  1/76 (1.32%)  1
General disorders   
Influenza Like Illness * 1  18/76 (23.68%)  18
Fatigue * 1  11/76 (14.47%)  11
Injection Site Pain * 1  7/76 (9.21%)  7
Injection Site Erythema * 1  5/76 (6.58%)  5
Irritability * 1  2/76 (2.63%)  2
Injection Site Haematoma * 1  1/76 (1.32%)  1
Injection Site Reaction * 1  1/76 (1.32%)  1
Pain * 1  1/76 (1.32%)  1
Hepatobiliary disorders   
Cytolytic Hepatitis * 1  3/76 (3.95%)  3
Hepatitis * 1  1/76 (1.32%)  1
Infections and infestations   
Bronchitis * 1  2/76 (2.63%)  2
Influenza * 1  2/76 (2.63%)  2
Tonsillitis * 1  2/76 (2.63%)  2
Urinary Tract Infection * 1  2/76 (2.63%)  2
Acarodermatitis * 1  1/76 (1.32%)  1
Nasopharyngitis * 1  1/76 (1.32%)  1
Rhinolaryngitis * 1  1/76 (1.32%)  1
Tracheitis * 1  1/76 (1.32%)  1
Urinary Tract Infection ba * 1  1/76 (1.32%)  1
Injury, poisoning and procedural complications   
Ankle Fracture * 1  1/76 (1.32%)  1
Clavicle Fracture * 1  1/76 (1.32%)  1
Joint Dislocation * 1  1/76 (1.32%)  1
Procedural Headache * 1  1/76 (1.32%)  1
Upper Limb Fracture * 1  1/76 (1.32%)  1
Wrist Fracture * 1  1/76 (1.32%)  1
Investigations   
Gamma-glutamyltransferase * 1  1/76 (1.32%)  1
Liver Function Test Abnormal * 1  1/76 (1.32%)  1
Musculoskeletal and connective tissue disorders   
Pain in Extremity * 1  4/76 (5.26%)  4
Arthralgia * 1  1/76 (1.32%)  1
Back Pain * 1  1/76 (1.32%)  1
Myalgia * 1  1/76 (1.32%)  1
Tendon Disorder * 1  1/76 (1.32%)  1
Tendonitis * 1  1/76 (1.32%)  1
Nervous system disorders   
Headache * 1  2/76 (2.63%)  2
Multiple Sclerosis Relapse * 1  40/76 (52.63%)  40
Migraine * 1  2/76 (2.63%)  2
Carpal Tunnel Syndrome * 1  1/76 (1.32%)  1
Neuralgia * 1  1/76 (1.32%)  1
Nystagmus * 1  1/76 (1.32%)  1
Paraesthesia * 1  1/76 (1.32%)  1
Restless Legs Syndrome * 1  1/76 (1.32%)  1
Sciatica * 1  1/76 (1.32%)  1
Pregnancy, puerperium and perinatal conditions   
Abortion Spontaneous * 1  1/76 (1.32%)  1
Pregnancy * 1  1/76 (1.32%)  1
Psychiatric disorders   
Depression * 1  6/76 (7.89%)  6
Anxiety * 1  2/76 (2.63%)  2
Insomnia * 1  2/76 (2.63%)  2
Depressed Mood * 1  1/76 (1.32%)  1
Emotional Distress * 1  1/76 (1.32%)  1
Mania * 1  1/76 (1.32%)  1
Panic Attack * 1  1/76 (1.32%)  1
Sleep Disorder * 1  1/76 (1.32%)  1
Respiratory, thoracic and mediastinal disorders   
Haemoptysis * 1  1/76 (1.32%)  1
Skin and subcutaneous tissue disorders   
Erythema * 1  2/76 (2.63%)  2
Rash * 1  1/76 (1.32%)  1
Vascular disorders   
Raynaud's Phenomenon * 1  1/76 (1.32%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
EMail: service@merckgroup.com
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
Layout table for additonal information
Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01201343    
Other Study ID Numbers: IMP 25206
First Submitted: September 13, 2010
First Posted: September 14, 2010
Results First Submitted: March 15, 2012
Results First Posted: April 11, 2012
Last Update Posted: December 27, 2013