Evidence to Support Montgomery-Asberg Depression Rating Scale Administration Every 24 Hours to Assess Rapid Onset of Treatment Response

Johnson, Kristen; Devine, John; Ho, Kai Fai; Howard, Kellee; Saretsky, T.; Jamieson, Carol

doi:10.4088/jcp.15m10253

Cited by 12 publications

(7 citation statements)

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“…All patients were rated using the CGI-S scale (at baseline and on days 4, 8, 15, 22, and 28), which permits a global evaluation of a patient's condition at a given time; MADRS (at baseline and on days 2, 8, 15, 22, and 28), with a recall period of 7 days for this study (except on day 2, which was for 24 hours) 17 ; SDS (at baseline and on days 15 and 28), with a recall period of 7 days; and PHQ-9 (at baseline and on days 15 and 28), with a recall period of 2 weeks. Note that remote independent raters completed all MADRS assessments to reduce potential bias on this primary efficacy outcome measure and potential unblinding owing to awareness of side effects.…”

Section: Methodsmentioning

confidence: 99%

Clinically meaningful changes on depressive symptom measures and patient‐reported outcomes in patients with treatment‐resistant depression

Turkoz

Alphs

Singh

et al. 2021

Acta Psychiatr Scand

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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.

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Section: Methodsmentioning

confidence: 99%

Clinically meaningful changes on depressive symptom measures and patient‐reported outcomes in patients with treatment‐resistant depression

Turkoz

Alphs

Singh

et al. 2021

Acta Psychiatr Scand

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“…The symptom aggregation results from patients with TRD in both TRANSFORM studies are generally consistent with those from previous studies of patients with MDD and TRD. (Galinowski & Lehert, 1995;Johnson et al, 2016;Suzuki et al, 2005;Williamson et al, 2006) The observation that the first factor, including anhedonia-related symptoms (inability to feel, lassitude) and sadness, accounted for most of the explained variance is not unexpected given that these symptoms are related to depression severity. (Burke et al, 2005;Fawcett et al, 1983) Anhedonia and depressed mood constitute core features of major depression: according to the DSM-V, at least five symptoms must occur for a diagnosis of MDD, one of which must be either depressed mood or anhedonia.…”

Section: Discussionmentioning

confidence: 88%

Section: Discussionmentioning

confidence: 99%

Montgomery‐Åsberg Depression Rating Scale factors in treatment‐resistant depression at onset of treatment: Derivation, replication, and change over time during treatment with esketamine

Borentain

Gogate

Williamson

et al. 2022

Int J Methods Psych Res

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Objective: Derive and confirm factor structure of the Montgomery-Åsberg Depression Rating Scale (MADRS) in patients with treatment-resistant depression (TRD) and evaluate how the factors evident at baseline change over 4 weeks of esketamine treatment. Methods: Two similarly-designed, short-term TRANSFORM trials randomized adults to esketamine or matching placebo nasal spray, each with a newly-initiated oral antidepressant, for 4 weeks (TRANSFORM-1: N = 342 patients; TRANS-FORM-2: N = 223 patients). The factor structure of MADRS item scores at baseline was determined by exploratory factor analysis in TRANSFORM-2 and corroborated by confirmatory factor analysis in TRANSFORM-1. Change in MADRS factor scores from baseline (day 1) to the end of the 28-day double-blind treatment phase of TRANSFORM-2 was analyzed using a mixed-effects model for repeated measures (MMRM).Results: Three factors were identified based on analysis of MADRS items: Factor 1 labeled affective and anhedonic symptoms (apparent sadness, reported sadness, lassitude, inability to feel), Factor 2 labeled anxiety and vegetative symptoms (inner tension, reduced sleep, reduced appetite, concentration difficulties), and Factor 3 labeled hopelessness (pessimistic thoughts, suicidal thoughts). The three-factor structure observed in TRANSFORM-2 was verified in TRANSFORM-1. Treatment benefit at 24 h with esketamine versus placebo was observed on all 3 factors and continued throughout the 4-week double-blind treatment period.

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“…22 The primary endpoint was change in MADRS total score (7-day recall) from baseline to Day 28 (end of double-blind treatment phase). Two key secondary endpoints were (1) change from baseline in MADRS total score (24-hour recall) at 24 hours post first dose (Day 2) 23 and (2) change from baseline in SDS total score at Day 28. Other secondary endpoints were change from baseline to Day 28 in CGI-S, GAD-7, and EQ-5D-5L, respectively.…”

Section: Efficacy Assessmentsmentioning

confidence: 99%

Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Plus a Newly Initiated Oral Antidepressant in Adult Patients with Treatment-Resistant Depression: A Randomized, Double-Blind, Multicenter, Active-Controlled Study Conducted in China and USA

Chen¹,

Hou²,

Bai³

et al. 2023

NDT

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Purpose This Phase 3, multicenter study (NCT03434041) was conducted in primarily Chinese patients with treatment-resistant depression (TRD) to support the registration of esketamine nasal spray in China. Patients and Methods This randomized, double-blind, active-controlled study was conducted in China and the United States (US) in patients with TRD (single or recurrent episode). Eligible patients were randomized 1:1 to receive intranasal esketamine or matching placebo, each in conjunction with a newly initiated oral antidepressant (AD; duloxetine, escitalopram, sertraline, and venlafaxine extended release) (ie, esketamine plus AD or AD plus placebo). The primary endpoint, change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Day 28, was analyzed using a mixed-effects model for repeated measures. Secondary endpoints including safety were also evaluated. Results Of 252 randomized patients (China, 224; US, 28), 214 completed the double-blind treatment phase. The difference between treatment groups at Day 28 was not statistically significant (difference in least-square means [95% CI]: −2.0 [−4.64, 0.55]; 2-sided p = 0.123). However, esketamine plus AD demonstrated a clinically meaningful treatment difference compared with AD plus placebo in MADRS total score at 24 hours after first dose for the study overall population and China sub-population (difference in least-square mean [95% CI]: −3.3 [−5.33, −1.33] and −2.6 [−4.64, −0.60], respectively). No new safety signals were observed. Conclusion Esketamine plus AD was not statistically superior to AD plus placebo in improving depressive symptoms in TRD patients at Day 28. Rapid reduction in depressive symptoms within 24 hours was observed for TRD patients treated with esketamine plus AD in the overall population and China sub-population. Safety was consistent with the established safety profile of esketamine.

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Evidence to Support Montgomery-Asberg Depression Rating Scale Administration Every 24 Hours to Assess Rapid Onset of Treatment Response

Abstract: ClinicalTrials.gov identifiers: NCT01627782 and NCT01640080.

Cited by 12 publications

References 0 publications

Clinically meaningful changes on depressive symptom measures and patient‐reported outcomes in patients with treatment‐resistant depression

Clinically meaningful changes on depressive symptom measures and patient‐reported outcomes in patients with treatment‐resistant depression

Montgomery‐Åsberg Depression Rating Scale factors in treatment‐resistant depression at onset of treatment: Derivation, replication, and change over time during treatment with esketamine

Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Plus a Newly Initiated Oral Antidepressant in Adult Patients with Treatment-Resistant Depression: A Randomized, Double-Blind, Multicenter, Active-Controlled Study Conducted in China and USA

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