PMID- 35546918
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230916
IS  - 1664-0640 (Print)
IS  - 1664-0640 (Electronic)
IS  - 1664-0640 (Linking)
VI  - 13
DP  - 2022
TI  - What Is the Minimum Clinically Important Change in Negative Symptoms of 
      Schizophrenia? PANSS Based Post-hoc Analyses of a Phase III Clinical Trial.
PG  - 816339
LID - 10.3389/fpsyt.2022.816339 [doi]
LID - 816339
AB  - INTRODUCTION: Minimum clinically important difference (MCID) is a measure that 
      defines the minimum amount of change in an objective score of a clinical test 
      that must be reached for that change to be clinically noticeable. We aimed to 
      find the MCID for patients with predominantly negative symptoms of schizophrenia 
      at its earliest occurrence. METHODS: Data of a 26-week long, double-blind study 
      with 454 patients [Positive and Negative Symptom Scale Negative Factor Score 
      (PANSS-FSNS) >/=24, Positive and Negative Symptom Scale Positive Factor Score 
      (PANSS-FSPS) </= 19] treated with cariprazine 4.5 mg/d or risperidone 4 mg/d were 
      analyzed. The Clinical Global Impression-Improvement scale was used to quantify 
      minimum improvement (CGI-I = 3) and no clinical change (CGI-I = 4) on the 
      PANSS-FSNS, and the MCID was estimated with the following methods: as the mean 
      PANSS-FSNS changes corresponding to the first instance of minimal improvement 
      across all visits (MCID(1)); as the difference between the PANSS-FSNS change 
      associated with the first instance and the PANSS-FSNS changes associated with the 
      last recorded clinically unchanged status across all visits (MCID(2)); with the 
      effect size approach (MCID(3)); as the Youden Index based cut-off value between 
      no clinical change and minimal improvement (MCID(4)); as the relative likelihood 
      of minimal improvement (MCID(5)). RESULTS: The MCID(1) and MCID(2) resulted in, 
      respectively, a 3.8-point (18.5%) and a 1.5-point (7.3%) decrease from baseline 
      severity on the PANSS-FSNS. Greater values were required for the MCID at later 
      evaluation times. The cut-off between minimum improvement and no clinical change 
      defined by the Youden Index was a-3-point (15%) change in the PANSS-FSNS. The 
      effect size approach indicated the 1.5-point difference between minimally 
      improved and unchanged patients to be a medium effect (ES = 0.6). CONCLUSION: 
      Applying different methods led to different results, ranging between 7.3 and 
      18.5% improvement from the baseline for the MCID at its earliest occurrence in 
      patients with predominantly negative symptoms of schizophrenia.
CI  - Copyright (c) 2022 Czobor, Sebe, Acsai, Barabassy, Laszlovszky, Nemeth, Furukawa 
      and Leucht.
FAU - Czobor, Pal
AU  - Czobor P
AD  - Department of Psychiatry and Psychotherapy, Semmelweis University, Budapest, 
      Hungary.
FAU - Sebe, Barbara
AU  - Sebe B
AD  - Global Medical Division, Gedeon Richter Plc, Budapest, Hungary.
FAU - Acsai, Karoly
AU  - Acsai K
AD  - Global Medical Division, Gedeon Richter Plc, Budapest, Hungary.
FAU - Barabassy, Agota
AU  - Barabassy A
AD  - Global Medical Division, Gedeon Richter Plc, Budapest, Hungary.
FAU - Laszlovszky, Istvan
AU  - Laszlovszky I
AD  - Global Medical Division, Gedeon Richter Plc, Budapest, Hungary.
FAU - Nemeth, Gyorgy
AU  - Nemeth G
AD  - Global Medical Division, Gedeon Richter Plc, Budapest, Hungary.
FAU - Furukawa, Toshi A
AU  - Furukawa TA
AD  - Department of Health Promotion and Human Behavior, Kyoto University School of 
      Public Health, Kyoto, Japan.
FAU - Leucht, Stefan
AU  - Leucht S
AD  - Department of Psychiatry and Psychotherapy, School of Medicine, Technical 
      University of Munich, Munich, Germany.
LA  - eng
PT  - Journal Article
DEP - 20220425
PL  - Switzerland
TA  - Front Psychiatry
JT  - Frontiers in psychiatry
JID - 101545006
PMC - PMC9083222
OTO - NOTNLM
OT  - MCID
OT  - cariprazine
OT  - clinical trial
OT  - minimum clinically important difference
OT  - negative symptoms
OT  - schizophrenia
COIS- PC, BS, KA, AB, IL, and GN reports personal fees from Gedeon Richter Plc., 
      outside the submitted work. TAF reports grants and personal fees from 
      Mitsubishi-Tanabe and from Shionogi, personal fees from MSD and from SONY, 
      outside the submitted work. In addition, TAF has a patent 2020-548587 concerning 
      smartphone CBT apps pending, and intellectual properties for Kokoro-app licensed 
      to Mitsubishi-Tanabe. SL reports honoraria as a consultant/advisor and/or for 
      lectures from Angelini, Bohringer Ingelheim, Geodon Richter, Janssen, Johnson & 
      Johnson, Lundbeck, LTS Lohmann, MSD, Otsuka, Recordati, SanofiAventis, Sandoz, 
      Sunovion, TEVA, Eisai, Rovi, and Medichem. GN and IL have issued patents for 
      cariprazine. This study was sponsored by Gedeon Richter Plc. Gedeon Richter was 
      involved in the study design, collection (via contracted clinical investigator 
      sites), analysis, and interpretation of data and decided to submit it for 
      publication.
EDAT- 2022/05/14 06:00
MHDA- 2022/05/14 06:01
PMCR- 2022/04/25
CRDT- 2022/05/13 11:07
PHST- 2021/11/16 00:00 [received]
PHST- 2022/02/23 00:00 [accepted]
PHST- 2022/05/13 11:07 [entrez]
PHST- 2022/05/14 06:00 [pubmed]
PHST- 2022/05/14 06:01 [medline]
PHST- 2022/04/25 00:00 [pmc-release]
AID - 10.3389/fpsyt.2022.816339 [doi]
PST - epublish
SO  - Front Psychiatry. 2022 Apr 25;13:816339. doi: 10.3389/fpsyt.2022.816339. 
      eCollection 2022.