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Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)

NCT05537558 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2022-09-13

No results posted yet for this study

Summary

Major depressive disorder (MDD) is the most common psychiatric disease worldwide with a huge socio-economic impact. Pharmacotherapy represents the first-line treatment choice; however, only about one third of patients respond to the first trial and about 30% are classified as treatment-resistant depression (TRD). TRD is associated with specific clinical features and genetic/gene expression signatures. To date, single sets of markers have shown limited power in response prediction. The aim of this project is the development of a precision medicine algorithm that would help early detection of non-responder patients, who might be more prone to later develop TRD.

In this phase of the project a naturalistic cohort of 300 MDD patients will be recruited. The data collected will be used to assess, in real-world conditions, the capability of an innovative algorithm (integrating clinical, omics and gender data of other 300 patients con MDD) to predict the treatment outcomes. This project represents a proof-of-concept study. The obtained results will provide information about the feasibility and usefulness of the proposed approach, with the perspective of designing future clinical trials in which algorithms could be tested as a predictive tool to drive decision making by clinicians, enabling a better prevention and management of MDD resistance.

Conditions

Interventions

DRUG

Antidepressant

Antidepressant (AD) monotherapy or complex psychopharmacology such as two ADs or AD plus augmentation (second generation antipsychotics, mood stabilizers, lithium, FT3/FT4). Combination with diverse types of ongoing psychotherapy will be accepted, if commenced prior to baseline

Sponsors & Collaborators

  • University of Cagliari

    collaborator OTHER

  • Poznan University of Medical Sciences

    collaborator OTHER

  • University Hospital Muenster

    lead OTHER

Principal Investigators

  • Bernhard T. Baune, Professor · University Hospital Muenster

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-09
Primary Completion
2023-09-09
Completion
2024-01-09

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05537558 on ClinicalTrials.gov