PMID- 34895291
OWN - NLM
STAT- MEDLINE
DCOM- 20211214
LR  - 20211216
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 22
IP  - 1
DP  - 2021 Dec 11
TI  - Clinical validation of a combinatorial PharmAcogeNomic approach in major 
      Depressive disorder: an Observational prospective RAndomized, participant and 
      rater-blinded, controlled trial (PANDORA trial).
PG  - 896
LID - 10.1186/s13063-021-05775-8 [doi]
LID - 896
AB  - BACKGROUND: Major depressive disorder (MDD) is a common, chronic, debilitating 
      mood disorder that causes serious functional impairment and significantly 
      decreased quality of life. Pharmacotherapy represents the first-line treatment 
      option; however, only approximately one third of patients respond to the first 
      treatment because of the ineffectiveness or side effects of antidepressants. 
      Precision medicine in psychiatry might offer clinicians the possibility to tailor 
      treatment according to the best possible evidence of efficacy and tolerability 
      for each subject. In this context, our study aims to carry out a clinical 
      validation of a combinatorial pharmacogenomics (PGx) test in an Italian MDD 
      patient cohort with advocacy license independence. METHODS: Our study is a 
      prospective participant- and rater-blinded, randomized, controlled clinical 
      observational trial enrolling 300 MDD patients who are referred to psychiatric 
      services to receive a new antidepressant due to the failure of their current 
      treatment and/or the onset of adverse effects. Eligible participants are 
      randomized to the TGTG group (Treated with Genetic Test Guide) or TAU group 
      (Treated as Usual). For all subjects, DNA is collected with a buccal brush. The 
      primary outcome is the reduction in depressive symptomatology. The secondary 
      outcomes involve a range of scales that assess MDD symptoms and social 
      functioning outcomes. The assessment is performed at four timepoints: baseline 
      and 4, 8, and 12 weeks. DISCUSSION: This project represents the first randomized 
      controlled clinical trial to investigate whether a non-commercial PGx test 
      improves outcomes in an MDD naturalistic cohort. Moreover, the identification of 
      new genetic variants associated with non-response or side effects will improve 
      the efficacy of the test, leading to further cost-saving. TRIAL REGISTRATION 
      NUMBER: ClinicalTrials.gov NCT04615234. Registered on November 4, 2020.
CI  - (c) 2021. The Author(s).
FAU - Minelli, Alessandra
AU  - Minelli A
AD  - Department of Molecular and Translational Medicine, University of Brescia, 
      Brescia, Italy.
AD  - Genetics Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Via 
      Pilastroni, 4, 25125, Brescia, Italy.
FAU - Barlati, Stefano
AU  - Barlati S
AD  - Department of Mental Health and Addiction Services, ASST Spedali Civili of 
      Brescia, Brescia, Italy.
AD  - Department of Clinical and Experimental Sciences, University of Brescia, Brescia, 
      Italy.
FAU - Vitali, Erika
AU  - Vitali E
AD  - Department of Molecular and Translational Medicine, University of Brescia, 
      Brescia, Italy.
AD  - Genetics Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Via 
      Pilastroni, 4, 25125, Brescia, Italy.
FAU - Bignotti, Stefano
AU  - Bignotti S
AD  - Psychiatry Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, 
      Brescia, Italy.
FAU - Dattilo, Vincenzo
AU  - Dattilo V
AD  - Genetics Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Via 
      Pilastroni, 4, 25125, Brescia, Italy.
FAU - Tura, Giovanni Battista
AU  - Tura GB
AD  - Psychiatry Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, 
      Brescia, Italy.
FAU - Maffioletti, Elisabetta
AU  - Maffioletti E
AD  - Department of Molecular and Translational Medicine, University of Brescia, 
      Brescia, Italy.
FAU - Giacopuzzi, Edoardo
AU  - Giacopuzzi E
AD  - Genetics Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Via 
      Pilastroni, 4, 25125, Brescia, Italy.
FAU - Santoro, Vincenza
AU  - Santoro V
AD  - Clinical and Experimental Medicine, University of Messina, Messina, Italy.
FAU - Perusi, Giulia
AU  - Perusi G
AD  - Department of Mental Health and Addiction Services, ASST Spedali Civili of 
      Brescia, Brescia, Italy.
FAU - Cobelli, Chiara
AU  - Cobelli C
AD  - Psychiatry Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, 
      Brescia, Italy.
FAU - Magri, Chiara
AU  - Magri C
AD  - Department of Molecular and Translational Medicine, University of Brescia, 
      Brescia, Italy.
FAU - Bonizzato, Silvia
AU  - Bonizzato S
AD  - Department of Mental Health and Addiction Services, ASST Spedali Civili of 
      Brescia, Brescia, Italy.
FAU - Bocchio-Chiavetto, Luisella
AU  - Bocchio-Chiavetto L
AD  - Genetics Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Via 
      Pilastroni, 4, 25125, Brescia, Italy.
AD  - Faculty of Psychology, eCampus University, Novedrate, Como, Italy.
FAU - Spina, Edoardo
AU  - Spina E
AD  - Clinical and Experimental Medicine, University of Messina, Messina, Italy.
FAU - Vita, Antonio
AU  - Vita A
AD  - Department of Mental Health and Addiction Services, ASST Spedali Civili of 
      Brescia, Brescia, Italy.
AD  - Department of Clinical and Experimental Sciences, University of Brescia, Brescia, 
      Italy.
FAU - Gennarelli, Massimo
AU  - Gennarelli M
AUID- ORCID: 0000-0003-4192-945X
AD  - Department of Molecular and Translational Medicine, University of Brescia, 
      Brescia, Italy. gennarelli@fatebenefratelli.eu.
AD  - Genetics Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Via 
      Pilastroni, 4, 25125, Brescia, Italy. gennarelli@fatebenefratelli.eu.
LA  - eng
SI  - ClinicalTrials.gov/NCT04615234
GR  - RF-2016-02361697/Italian Ministry of Health/
PT  - Journal Article
PT  - Observational Study
PT  - Randomized Controlled Trial
DEP - 20211211
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
RN  - 0 (Antidepressive Agents)
SB  - IM
MH  - Antidepressive Agents/adverse effects
MH  - *Depressive Disorder, Major/diagnosis/drug therapy/genetics
MH  - Humans
MH  - Pharmacogenetics
MH  - Prospective Studies
MH  - Quality of Life
PMC - PMC8665317
OTO - NOTNLM
OT  - Antidepressant response
OT  - Depression
OT  - Efficacy
OT  - Major depressive disorder
OT  - Pharmacogenetic testing
OT  - Precision medicine
OT  - Randomized controlled clinical
COIS- The authors declare that they have no competing interests.
EDAT- 2021/12/14 06:00
MHDA- 2021/12/15 06:00
PMCR- 2021/12/11
CRDT- 2021/12/13 11:44
PHST- 2021/04/15 00:00 [received]
PHST- 2021/10/29 00:00 [accepted]
PHST- 2021/12/13 11:44 [entrez]
PHST- 2021/12/14 06:00 [pubmed]
PHST- 2021/12/15 06:00 [medline]
PHST- 2021/12/11 00:00 [pmc-release]
AID - 10.1186/s13063-021-05775-8 [pii]
AID - 5775 [pii]
AID - 10.1186/s13063-021-05775-8 [doi]
PST - epublish
SO  - Trials. 2021 Dec 11;22(1):896. doi: 10.1186/s13063-021-05775-8.