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

Toward PrecisiOn Medicine for the Prediction of Treatment Response in Major Depressive Disorder Through Stratification of Combined Clinical And-omics Signatures (PROMPT)

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.

Study Overview

• Status: Recruiting
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Antidepressant

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Bernhard T. Baune, Professor; Phone Number: 0049 251 8356664; Email: bernhard.baune@ukmuenster.de

Study Locations

• Germany
  • Münster, Germany, D-48159
    • Recruiting
    • Bernhard Baune

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical response	Symptom improvement as measured by the percent change in the Montgomery-Asberg Depression Rating Scale (MADRS) score	Baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical response and remission	Symptom improvement as well as response and remission rates as according to the MADRS	Baseline to 2 weeks, to 4 weeks, to 8 weeks and 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical response and remission self-reported	Changes in scores of depressive symptoms as measured by the Beck Depression Inventory II (BDI-II). Score on the BDI-II can range from 0 to 63 with higher scores indicating greater severity of depression.	Baseline to 2 weeks, to 4 weeks, to 8 weeks and 12 weeks
Clinical response and remission self-reported	Changes in scores of anxiety symptoms as measured by the Beck Anxiety Inventory (BAI). Score on the BAI can range from 0 to 63 with higher scores indicating higher level of anxiety.	Baseline to 2 weeks, to 4 weeks, to 8 weeks and 12 weeks
Psychosocial functioning	Changes in scores of psychosocial functioning as measured by the Functioning Assessment Short Test 24 items (FAST). All of items are rated using a 4-point scale. The global score is obtained when the scores of each item are added up. The higher the score, the more serious the difficulties are.	Baseline to 4 weeks, to 8 weeks and 12 weeks
Side effects	Changes in side effects assessed by the UKU Side Effect Rating Scale (UKU-SERS). All of items are rated using a 3-point scale. Score can range from 0 to 63 with higher scores indicating more side effects.	Baseline to 4 weeks, to 8 weeks and 12 weeks
Suicidal risk	Changes in scores of suicidal risk as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS). Scores on the C-SSRS can range from 0 to 25 with higher scores indicating higher intensity of suicidal risk. Anyway any score greater than 0 is important and may indicate the need for mental health intervention. The suicidal behavior lethality rating is taken directly from the C-SSRS.	Baseline to 2 weeks, to 4 weeks, to 8 weeks and 12 weeks
Perceived stress	Changes in scores of perceived stress as measured by the Perceived Stress Scale-10 (PSS-10). Individual scores on the PSS-10 can range from 0 to 40 with higher scores indicating higher perceived stress.	Baseline to 4 weeks, to 8 weeks and 12 weeks
General Health and Quality of Life	Changes in scores of quality of life as measured by the Quality of Life Questionnaire (SF-36). Consisting of 8 domains. The scores for each domain range from 0 to 100, with higher scores indicating more favorable health status.	Baseline to 4 weeks, to 8 weeks and 12 weeks

Collaborators and Investigators

• Sponsor: University Hospital Muenster
• Collaborators: Poznan University of Medical Sciences; University of Cagliari
• Investigators: Principal Investigator: Bernhard T. Baune, Professor, University Hospital Muenster

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 9, 2021
• Primary Completion (ANTICIPATED): September 9, 2023
• Study Completion (ANTICIPATED): January 9, 2024

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (ACTUAL): September 13, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 12, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Psychotropic Drugs; Antidepressive Agents
• Other Study ID Numbers: University_of_Muenster_PROMPT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No