Meaningful Change in Depression Symptoms Assessed with the Patient Health Questionnaire (PHQ-9) and Montgomery-Åsberg Depression Rating Scale (MADRS) Among Patients with Treatment Resistant Depression in Two, Randomized, Double-blind, Active-controlled Trials of Esketamine Nasal Spray Combined With a New Oral Antidepressant.
Background: Patients with major depressive disorder who do not respond to ≥2 different pharmacological treatments within the current depressive episode are considered to have treatment resistant depression (TRD). This analysis determined meaningful change thresholds (MCT) of the Patient Health Quest...
| Published in: | Journal of Affective Disorders Vol. 281; pp. 767 - 776 |
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| Main Authors: | , , , , , , , , , |
| Format: | research tables/charts Journal Article |
| Published: |
Elsevier B.V.
Feb2021
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| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=148185892&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 148185892 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 01650327 3M9 jtl: Journal of Affective Disorders issn: 01650327 maglogo: N pubinfo: dt: Feb2021 vid: 281 pid: 1004 pub: Elsevier B.V. artinfo: ui: 148185892 148185892 NLM33261932 148185892 10.1016/j.jad.2020.11.066 NLM33261932 148185892 ppf: 767 ppct: 9 formats: tig: atl: Meaningful Change in Depression Symptoms Assessed with the Patient Health Questionnaire (PHQ-9) and Montgomery-Åsberg Depression Rating Scale (MADRS) Among Patients with Treatment Resistant Depression in Two, Randomized, Double-blind, Active-controlled Trials of Esketamine Nasal Spray Combined With a New Oral Antidepressant. aug: au: Hudgens, Stacie Floden, Lysbeth Blackowicz, Michael Jamieson, Carol Popova, Vanina Fedgchin, Maggie Drevets, Wayne C. Cooper, Kimberly Lane, Rosanne Singh, Jaskaran affil: Clinical Outcomes Solutions, Tucson, AZ, US sug: subj: Depression Drug Therapy Double-Blind Studies Depression Treatment Outcomes Ketamine Antidepressive Agents Therapeutic Use Aerosols Administration and Dosage Human Comparative Studies Multicenter Studies Evaluation Research Validation Studies Questionnaires Scales ab: Background: Patients with major depressive disorder who do not respond to ≥2 different pharmacological treatments within the current depressive episode are considered to have treatment resistant depression (TRD). This analysis determined meaningful change thresholds (MCT) of the Patient Health Questionnaire (PHQ-9) and Montgomery-Åsberg Depression Rating Scale (MADRS) using anchor-based methods and compared proportions of meaningful changes in patients with TRD across treatment groups from two Phase 3 trials for esketamine nasal spray (SPRAVATOTM).Methods: Data from two Phase 3 trials in patients with TRD, TRANSFORM-1 and -2, were used in this analysis. The MCTs for the PHQ-9 and MADRS were derived using a clinician global impression of severity anchor. Blinded probability density functions displayed score distributions between anchor categories. Proportions of meaningful response were compared between treatment groups using chi-square tests supported by unblinded cumulative distribution functions of change scores.Results: Baseline scores were similar for the PHQ-9 and MADRS between the esketamine/antidepressant (AD) and AD/placebo groups. The most appropriate MCT on the PHQ-9 was -6 points. By Day 28, 86.5% of patients reached or exceeded the PHQ-9 MCT in the esketamine/AD group compared to 70% in the placebo/AD group. The most appropriate MCT for the MADRS was -10 points. By Day 28, 78.2% of patients reached or exceeded the MADRS MCT in the esketamine/AD group compared to 65.0% in the placebo/AD group.Conclusions: Individual-level meaningful change for the PHQ-9 and MADRS was effectively quantified using a clinical anchor to interpret efficacy from patients with TRD and their treating clinicians. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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