Evaluation of Emotional Disorders During Treatment by Interferon Beta
Evaluation of Emotional Disorders During Treatment by Interferon Beta in Relapsing-remitting Multiple Sclerosis Patients
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Interferon beta-1a
Interferon alpha/beta receptor agonist
Results by group
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
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Interferon-beta | 12.7 units on a scale | 4.4 (Standard Deviation) | 70 |
| Interferon-beta | -0.5 units on a scale | 4.2 (Standard Deviation) | 70 |
Interferon-beta
Interferon-beta
Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 18
Baseline and Month 18
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Interferon-beta | -0.6 units on a scale | 4.6 (Standard Deviation) | 61 |
Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 24
Baseline and Month 24
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Interferon-beta | -0.1 units on a scale | 5.2 (Standard Deviation) | 63 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Interferon-beta | 76 | 9 (11.8%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main 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
Mood and sleepChange From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 18
Baseline and Month 18
Mood and sleepChange From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 24
Baseline and Month 24
Mood and sleep
Other measures (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
Mood and sleepChange 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
Mood and sleepChange 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
Mood and sleepChange 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
Fatigue
Who could take part
Relapsing MS · 18 and over
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Background
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.Background
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.
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History
Started
Jan 2005
Main results due
Jul 2010
Finished
Jul 2010
Results posted
Apr 2012