Phase 4 N=79 Treatment

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

Multiple Sclerosis, Relapsing, Remitting

Bottom Line

View on ClinicalTrials.gov: NCT01201343 ↗

Enrolled (actual)

Serious AEs

11.8%

Results posted

Apr 2012

Primary outcome: Primary: Change From Baseline in Emotional Dyscontrol Sub-score of the Depressive Mood Scale (Echelle d'Humeur Depressive [EHD]) Scale at Month 12 — 12.7; -0.5 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Interferon beta-1a (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Merck KGaA, Darmstadt, Germany
Primary completion: Jul 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Emotional Dyscontrol Sub-score of the Depressive Mood Scale (Echelle d'Humeur Depressive [EHD]) Scale at Month 12	12.7; -0.5	—
PRIMARY Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 18	-0.6	—
PRIMARY Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 24	-0.1	—
SECONDARY 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	5.6; 0.3; -0.1; -0.0; -0.0; -0.2	—
SECONDARY Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24	35.9; 0.8; 0.3; -1.7; -1.5; -0.8	—
SECONDARY 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	13.5; 1.0; 1.5; -0.5; -1.0; -1.1	—
SECONDARY 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	16.8; 0.0; 1.0; -0.0; -0.3; -0.0	—
SECONDARY Change From Baseline in Fatigue Score at Months 1, 2, 3, 6, 12 and 24	2.1; 0.5; 0.4; 0.2; 0.4; 0.1	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01201343). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.