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

Major Depressive Disorder Clinical Trial

— PROMPT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05537558
• Other study ID #: University_of_Muenster_PROMPT
• Status: Recruiting
• Start date: September 9, 2021
• Est. completion date: January 9, 2024

Study information

• Verified date: September 2022
• Source: University Hospital Muenster
• Contact: Bernhard T. Baune, Professor
• Phone: 0049 251 8356664
• Email: bernhard.baune[@]ukmuenster.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 9, 2024
• Est. primary completion date: September 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
Germany	Bernhard Baune	Münster

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Muenster	Poznan University of Medical Sciences, University of Cagliari

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	Clinical response	Symptom improvement as measured by the percent change in the Montgomery-Asberg Depression Rating Scale (MADRS) score	Baseline to 8 weeks
Secondary	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