NCT04615234: PANDORA

Clinical Validation of a Combinatorial Pharmacogenomic Approach in Major Depressive Disorder

Status unknown Last updated 15 September 2022

What this trial tests

trial testing Pharmacogenomics test (PGx) in Major Depressive Disorder in 300 participants. Status unknown.

Timeline

1 February 2020

Primary endpoint
1 September 2022

1 March 2023

Quick facts

Lead sponsor	Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	300
Start date	1 February 2020
Primary completion	1 September 2022
Estimated completion	1 March 2023
Sites	1 location across Italy

Drugs / interventions tested

• Pharmacogenomics test (PGx)

Conditions studied

• Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia — full company profile →

Who can join

Adults 18 to 65, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Major depressive disorder (MDD) is a common, chronic, debilitating mood disorder causing serious functional impairment and significantly decreased quality of life. Pharmacotherapy represents the first-line treatment choice; however, only about one third of patients respond to the first trial because of antidepressants ineffectiveness or side-effects. This causes suffering for patients and their families and significantly contributes to pushing up costs for healthcare services. Precision medicine in psychiatry might offer to clinicians the possibility to tailor the treatment according to the best possible evidence of effectiveness 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 an advocacy license independence.

Our study is a prospective single-blind randomized controlled clinical observational trial enrolling 300 MDD patients. Patients referred to psychiatric services due to the failure and/or the onset of adverse effects of their current treatment for receiving a new antidepressant. Eligible participants with a primary diagnosis of MDD according to DSM-5 criteria and a Hamilton Depression Rating Scale (HAM-D17) with a score \> 14 are randomized to TGTG group (Treated with Genetic Test Guide) or TAU group (Treated as Usual). For all subjects, buccal brush for DNA is collected. The primary outcome is the reduction in depressive symptomatology as measured by HAM-D17. 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. This project represents the first randomized controlled clinical trial in which is tested whether a non-commercial PGx test improves outcomes in a 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 a further cost-saving.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical validation of a combinatorial PharmAcogeNomic approach in major Depressive disorder: an Observational prospective RAndomized, participant and rater-blinded, controlled trial (PANDORA trial).
   Minelli A, Barlati S, Vitali E, Bignotti S, et al · · 2021 · cited 10× · PMID 34895291 · DOI 10.1186/s13063-021-05775-8
2. Does pharmacogenetic testing optimize antidepressant effectiveness in major depressive disorder? Data from a double-blind randomized controlled trial in a real-world clinical setting.
   Minelli A, Barlati S, Bignotti S, Menesello V, et al · · 2025 · cited 1× · PMID 41277612 · DOI 10.1192/j.eurpsy.2025.10132