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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05537558
Other study ID # University_of_Muenster_PROMPT
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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