ArticleActa psychiatrica Scandinavica2021
Clinically meaningful changes on depressive symptom measures and patient-reported outcomes in patients with treatment-resistant depression.
Article in Acta psychiatrica Scandinavica, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 58 papers, 3 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
58 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Efficacy and Moderators of Mindfulness-Based Cognitive Therapy in Difficult-to-Treat Depression: A Systematic Review and Individual Participant Data Meta-Analysis.Psychotherapy and psychosomatics · 2026Pooled it
- Time matters for metas: a systematic review and meta-analysis of ect vs ketamine for depression incorporating time.Translational psychiatry · 2026Pooled it
- Peer-supported interventions for people with spinal cord injury.The Cochrane database of systematic reviews · 2024Pooled it
- Supporting the Primary Outcomes of the Mirai Trial for the Adjunctive Digital Therapeutic Rejoyn (CT-152) in the Treatment of Major Depressive Disorder: Meaningful Change Analysis in the Montgomery-Åsberg Depression Rating Scale.JMIR formative research · 2026Trial
- Prefrontal Transcranial Pulse Stimulation for Major Depressive Disorder: A Randomized Clinical Trial.JAMA network open · 2026Trial
- GH001 vs Placebo in Patients With Treatment-Resistant Depression: A Randomized Clinical Trial.JAMA psychiatry · 2026Trial
- Short-Term and Late-Term Effects of Psilocybin on Symptoms in Major Depression: A Randomized Clinical Trial.JAMA network open · 2026Trial
- Lavender oil preparation Silexan is effective in mild-to-moderate major depression: a randomized, placebo- and reference-controlled trial.European archives of psychiatry and clinical neuroscience · 2025Trial
- Psilocybin Therapy for Clinicians With Symptoms of Depression From Frontline Care During the COVID-19 Pandemic: A Randomized Clinical Trial.JAMA network open · 2024Trial
- A double-blind, placebo-controlled, randomised withdrawal study of adjunctive brexpiprazole maintenance treatment for major depressive disorder.Acta neuropsychiatrica · 2024Trial
- Metabolic Status Influences Probiotic Efficacy for Depression-PRO-DEMET Randomized Clinical Trial Results.Nutrients · 2024Trial
- Gender Differences in Psychological Outcomes Following Surf versus Hike Therapy among U.S. Service Members.International journal of environmental research and public health · 2024Trial
- Connectivity-guided intermittent theta burst versus repetitive transcranial magnetic stimulation for treatment-resistant depression: a randomized controlled trial.Nature medicine · 2024Trial
- Assessment of health-related quality of life and health status in patients with treatment-resistant depression treated with esketamine nasal spray plus an oral antidepressant.Health and quality of life outcomes · 2023Trial
- Effectiveness of Internet-Based Cognitive Behavioral Therapy With Telephone Support for Noncardiac Chest Pain: Randomized Controlled Trial.Journal of medical Internet research · 2022Trial
- Clinically Significant Changes in the 17- and 6-Item Hamilton Rating Scales for Depression: A STAR*D Report.Neuropsychiatric disease and treatment · 2021Trial
- Pimavanserin Exposure-Response Analyses in Patients With Schizophrenia: Results From the Phase 2 ADVANCE Study.Journal of clinical psychopharmacologyTrial
- Real-World Effectiveness and Safety of Esketamine Nasal Spray in Treatment-Resistant Depression: A Retrospective Observational Study.Healthcare (Basel, Switzerland) · 2026Article
- Ecological assessment of transdiagnostic clinical symptoms in serious mental illness with daily smartphone surveys.Translational psychiatry · 2026Article
- Digital phenotyping with large language models to detect depressive state changes in patients.NPJ digital medicine · 2026Article
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo 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).
methodsPooled 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.
resultsClinically 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).
conclusionWe 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.
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