Major Depressive DisorderPROMPTNCT05537558
Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)
An observational study of Major Depressive Disorder, run by University Hospital Muenster at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Antidepressant
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- 9 Sep 2021to 9 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: MDD in-patients or out-patients referred to psychiatric services are voluntarily enrolling in the study
Who may be able to join
- A current diagnosis of moderate to severe MDD according to the DSM-IV was confirmed using the SCID-I diagnostic scale
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Bernhard Baune
Münster, D-48159
Alessandra Minelli, Dr, + 39 0303501255, alessandra.minelli@unibs.it
About this study
Official title: 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Antidepressant
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntidepressantDrug
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response
Symptom improvement as measured by the percent change in the Montgomery-Asberg Depression Rating Scale (MADRS) score
Measured: Baseline to 8 weeks
Secondary outcomes (1)
Clinical response and remission
Symptom improvement as well as response and remission rates as according to the MADRS
Measured: Baseline to 2 weeks, to 4 weeks, to 8 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start9 Sep 2021
- Primary completion9 Sep 2023 (estimated)
- Study completion9 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cagliari, Poznan University of Medical Sciences
- Responsible party
- Principal investigator, Bernhard Baune, University Hospital Muenster
- Investigators
- Bernhard T. Baune, Professor, Principal investigator, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537558
- Sponsor's protocol ID
- University_of_Muenster_PROMPT
- Acronym
- PROMPT
- Status last verified
- Sep 2022
- First submitted
- 30 Aug 2022
- Last updated
- 13 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toward PrecisiOn Medicine for the Prediction of Treatment Response in Major Depressive Disorder Through Stratification of Combined Clinical And-omics Signatures (PROMPT)
- ClinicalTrials.gov ID
- NCT05537558
- Acronym / sponsor ID
- PROMPT / University_of_Muenster_PROMPT
- Conditions
- Major Depressive Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- University of Cagliari, Poznan University of Medical Sciences
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 9 Sep 2023 (estimated)
- Study completion
- 9 Jan 2024 (estimated)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- MDD in-patients or out-patients referred to psychiatric services are voluntarily enrolling in the study
Key inclusion criteria (1 listed)
- A current diagnosis of moderate to severe MDD according to the DSM-IV was confirmed using the SCID-I diagnostic scale
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntidepressantAntidepressant (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 | Drug | – |
Primary outcome
Clinical response
Time frame: Baseline to 8 weeks
Symptom improvement as measured by the percent change in the Montgomery-Asberg Depression Rating Scale (MADRS) score
1 secondary outcome
Clinical response and remission
Time frame: Baseline to 2 weeks, to 4 weeks, to 8 weeks and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernhard T. Baune, Professor principal investigator
University Hospital Muenster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bernhard T. Baune, Professor (0049 251 8356664, bernhard.baune@ukmuenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response (time frame: Baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.