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

Autor: Borentain S; Department of Global Medical Affairs, Janssen Research & Development, LLC, Titusville, New Jersey, USA., Gogate J; Department of Statistics & Decision Sciences, Janssen Research & Development LLC, Raritan, New Jersey, USA., Williamson D; Clinical Medical Affairs, Janssen Scientific Affairs LLC, Titusville, New Jersey, USA., Carmody T; Department of Psychiatry, UT Southwestern Medical Center, Dallas, Texas, USA., Trivedi M; Department of Psychiatry, UT Southwestern Medical Center, Dallas, Texas, USA., Jamieson C; Patient Reported Outcomes, Janssen Research & Development LLC, Milpitas, California, USA., Cabrera P; Department of Global Medical Affairs, Janssen Global Services LLC, Titusville, New Jersey, USA., Popova V; Department of Neuroscience, Janssen Research & Development, Beerse, Belgium., Wajs E; Department of Neuroscience, Janssen Research & Development, Beerse, Belgium., DiBernardo A; Department of Global Medical Affairs, Janssen Research & Development, LLC, Titusville, New Jersey, USA., Daly EJ; Clinical Medical Affairs, Janssen Scientific Affairs LLC, Titusville, New Jersey, USA.
Jazyk: angličtina
Zdroj: International journal of methods in psychiatric research [Int J Methods Psychiatr Res] 2022 Dec; Vol. 31 (4), pp. e1927. Date of Electronic Publication: 2022 Jun 24.
DOI: 10.1002/mpr.1927
Abstrakt: 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; TRANSFORM-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.
Conclusions: A three-factor structure for MADRS appears to generalize to TRD. All three factors improved over 4 weeks of treatment with esketamine nasal spray.
(© 2022 Janssen Research & Development, LLC. International Journal of Methods in Psychiatric Research published by John Wiley & Sons Ltd.)
Databáze: MEDLINE
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