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

NCT05537558 | Unknown

• 1 other identifier: University_of_Muenster_PROMPT
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Clinical response

  Symptom improvement as measured by the percent change in the Montgomery-Asberg Depression Rating Scale (MADRS) score

  Baseline to 8 weeks

Secondary Outcomes (1)

• Clinical response and remission

  Baseline to 2 weeks, to 4 weeks, to 8 weeks and 12 weeks

Other Outcomes (7)

• Clinical response and remission self-reported

  Baseline to 2 weeks, to 4 weeks, to 8 weeks and 12 weeks

• Clinical response and remission self-reported

  Baseline to 2 weeks, to 4 weeks, to 8 weeks and 12 weeks

• Psychosocial functioning

  Baseline to 4 weeks, to 8 weeks and 12 weeks

Interventions

Antidepressant DRUG

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

MDD in-patients or out-patients referred to psychiatric services are voluntarily enrolling in the study

You may qualify if:

• A current diagnosis of moderate to severe MDD according to the DSM-IV was confirmed using the SCID-I diagnostic scale

You may not qualify if:

• Mental retardation or cognitive disorder
• A lifetime history of schizophrenic, schizoaffective, or bipolar disorder Substance abuse in the last 3 months
• Personality disorders, substance abuse, alcohol abuse, obsessive compulsive disorder, post-traumatic stress disorder, as primary diagnosis
• Comorbidity with eating disorders
• Substance or alcohol dependence

Sponsors & Collaborators

• University Hospital Muenster: lead
• University of Cagliari: collaborator
• Poznan University of Medical Sciences: collaborator

Study Sites (1)

Bernhard Baune

Münster, D-48159, Germany

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Antidepressive Agents

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Bernhard T. Baune, Professor

  University Hospital Muenster

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernhard T. Baune, Professor

CONTACT

0049 251 8356664; bernhard.baune@ukmuenster.de

Alessandra Minelli, Dr

CONTACT

+ 39 0303501255; alessandra.minelli@unibs.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 13, 2022
• Study Start: September 9, 2021
• Primary Completion: September 9, 2023
• Study Completion: January 9, 2024
• Last Updated: September 13, 2022

Record last verified: 2022-09

Locations

DE (1)