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

Sponsor
University Hospital Muenster (Other)
Overall Status
Recruiting
CT.gov ID
NCT05537558
Collaborator
University of Cagliari (Other), Poznan University of Medical Sciences (Other)
300
1
28
10.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Toward PrecisiOn Medicine for the Prediction of Treatment Response in Major Depressive Disorder Through Stratification of Combined Clinical And-omics Signatures (PROMPT)
Actual Study Start Date :
Sep 9, 2021
Anticipated Primary Completion Date :
Sep 9, 2023
Anticipated Study Completion Date :
Jan 9, 2024

Outcome Measures

Primary Outcome Measures

  1. Clinical response [Baseline to 8 weeks]

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

Secondary Outcome Measures

  1. Clinical response and remission [Baseline to 2 weeks, to 4 weeks, to 8 weeks and 12 weeks]

    Symptom improvement as well as response and remission rates as according to the MADRS

Other Outcome Measures

  1. Clinical response and remission self-reported [Baseline to 2 weeks, to 4 weeks, to 8 weeks and 12 weeks]

    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.

  2. Clinical response and remission self-reported [Baseline to 2 weeks, to 4 weeks, to 8 weeks and 12 weeks]

    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.

  3. Psychosocial functioning [Baseline to 4 weeks, to 8 weeks and 12 weeks]

    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.

  4. Side effects [Baseline to 4 weeks, to 8 weeks and 12 weeks]

    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.

  5. Suicidal risk [Baseline to 2 weeks, to 4 weeks, to 8 weeks and 12 weeks]

    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.

  6. Perceived stress [Baseline to 4 weeks, to 8 weeks and 12 weeks]

    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.

  7. General Health and Quality of Life [Baseline to 4 weeks, to 8 weeks and 12 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bernhard Baune Münster Germany D-48159

Sponsors and Collaborators

  • University Hospital Muenster
  • University of Cagliari
  • Poznan University of Medical Sciences

Investigators

  • Principal Investigator: Bernhard T. Baune, Professor, University Hospital Muenster

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bernhard Baune, Professor, University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT05537558
Other Study ID Numbers:
  • University_of_Muenster_PROMPT
First Posted:
Sep 13, 2022
Last Update Posted:
Sep 13, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2022