title: Evidence to Support Montgomery-Asberg Depression Rating Scale Administration Every 24 Hours to Assess Rapid Onset of Treatment Response.
abstract: OBJECTIVE
  This study investigated the suitability of the Montgomery-Asberg Depression Rating Scale (MADRS), with a 24-hour recall period (MADRS-24hr), to assess the rapid onset of the antidepressant effect of a treatment in patients with treatment-resistant depression (TRD). Psychometric properties of the MADRS-24hr were assessed together with qualitative assessment of content validity.
  
  
  METHODS
  Content validity was assessed using semistructured interviews conducted from November 2013 to December 2013 in patients (18-64 years old) with TRD who met DSM-IV diagnostic criteria and health care professionals (HCPs) experienced in treating major depressive disorder and familiar with using the MADRS. The psychometric properties of MADRS-24hr were evaluated using data from 2 randomized clinical studies involving patients with TRD.
  
  
  RESULTS
  A total of 23 patients (15 [65%] women) with TRD (mean age = 45 years) and 11 HCPs were interviewed. With the exception of reduced sleep, the majority of patients and HCPs reported that the items captured in the MADRS can fluctuate in a 24-hour period. The majority of participants also reported that a meaningful change in depression symptoms could be assessed in a 24-hour recall period, except for reduced sleep and appetite. Assessment of the psychometric properties of the MADRS-24hr showed that this instrument had high internal consistency reliability (Cronbach α of 0.84 and 0.91) and test-retest reliability (intraclass correlation coefficients of 0.96 and 0.91), had construct validity, and was responsive to change following an intervention.
  
  
  CONCLUSIONS
  Overall, results suggest that MADRS-24hr can be used to assess the rapid onset of antidepressant efficacy of a treatment in patients with TRD.
  
  
  BACKGROUND
  ClinicalTrials.gov identifiers: NCT01627782 and NCT01640080.
authors.affiliation: Janssen Global Services, LLC, Raritan, New Jersey, USA.
authors.forename: Kristen M
authors.initials: KM
authors.lastname: Johnson
authors.affiliation: Oxford Outcomes, San Francisco, California, USA.
authors.forename: Jacob M
authors.initials: JM
authors.lastname: Devine
authors.affiliation: STAT-TU Inc, Toronto, Ontario, Canada.
authors.forename: Kai Fai
authors.initials: KF
authors.lastname: Ho
authors.affiliation: Oxford Outcomes, San Francisco, California, USA.
authors.forename: Kellee A
authors.initials: KA
authors.lastname: Howard
authors.affiliation: Oxford Outcomes, San Francisco, California, USA.
authors.forename: Todd L
authors.initials: TL
authors.lastname: Saretsky
authors.affiliation: Janssen Global Services, LLC, Patient Reported Outcomes, 700 US, 202 Raritan Ave, Raritan, NJ 08869. cjamies2@its.jnj.com.|Janssen Global Services, LLC, Raritan, New Jersey, USA.
authors.forename: Carol A
authors.initials: CA
authors.lastname: Jamieson
mesh_terms: D000328:Adult; D000928:Antidepressive Agents / Q000494:pharmacology*; D003865:Major Depressive Disorder / Q000188:drug therapy*; D061218:Depressive Disorder, Treatment-Resistant / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000592:standards*; D011569:Psychiatric Status Rating Scales / Q000592:standards*; D011594:Psychometrics / Q000295:instrumentation*; D015203:Reproducibility of Results; D013997:Time Factors; D055815:Young Adult
chemical_list: D000928:Antidepressive Agents