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Clinically meaningful changes on depressive symptom measures and patient-reported outcomes in patients with treatment-resistant depression
- Source :
- Acta Psychiatrica Scandinavica
- Publication Year :
- 2020
-
Abstract
- Objective To use the Clinical Global Impression‐Severity (CGI‐S) scale to estimate clinically meaningful and clinically substantial changes as measured using the Montgomery‐Åsberg Depression Rating Scale (MADRS), the Sheehan Disability Scale (SDS), and the Patient Health Questionnaire‐9 (PHQ‐9) in patients with treatment‐resistant depression (TRD). Methods Pooled data were derived from two 4‐week, randomized, active‐controlled studies evaluating esketamine nasal spray (ESK) plus oral antidepressant (OAD) or OAD plus placebo nasal spray (PBO) in adults with TRD (N = 565). CGI‐S, MADRS, SDS, and PHQ‐9 scores were obtained at baseline and over 4 weeks of treatment. In this post hoc analysis, change scores on the MADRS, SDS, and PHQ‐9 that corresponded to a clinically meaningful (1‐point) or clinically substantial (2‐point) change on the CGI‐S scale were identified. Results Clinically meaningful changes in CGI‐S scores after 28 days corresponded to 6‐, 4‐, and 3‐point changes from baseline on the MADRS, SDS, and PHQ‐9, respectively. Similarly, a 2‐point CGI‐S score change (clinically substantial change) corresponded to a 12‐, 8‐, and 6‐point change on the MADRS, SDS, and PHQ‐9, respectively. The proportion of patients showing substantial clinical improvement in the ESK plus OAD group versus the OAD plus PBO group after 28 days of treatment favored ESK plus OAD: 69.0% vs 55.3% (MADRS), 64.5% vs 48.9% (SDS), and 77.1% vs 64.7% (PHQ‐9). Conclusion We provide a basis for identifying clinically meaningful and clinically substantial changes as assessed with commonly used outcome measures for depression to facilitate the translation of clinical trial results into clinical practice.
- Subjects :
- Adult
medicine.medical_specialty
medicine.medical_treatment
antidepressives
Placebo
03 medical and health sciences
Depressive Disorder, Treatment-Resistant
0302 clinical medicine
Quality of life
Double-Blind Method
Rating scale
Internal medicine
Post-hoc analysis
medicine
Humans
clinical aspects
Patient Reported Outcome Measures
Depression (differential diagnoses)
Depressive Disorder, Major
treatment
business.industry
Depression
Original Articles
medicine.disease
humanities
030227 psychiatry
Psychiatry and Mental health
Esketamine
Treatment Outcome
Nasal spray
quality of life
Original Article
sense organs
business
Treatment-resistant depression
030217 neurology & neurosurgery
medicine.drug
Subjects
Details
- ISSN :
- 16000447
- Volume :
- 143
- Issue :
- 3
- Database :
- OpenAIRE
- Journal :
- Acta psychiatrica Scandinavica
- Accession number :
- edsair.doi.dedup.....be3055915ef93c3287e07ae4d0fe471c