Major Depressive DisorderP4DNCT06027177
Personalized, Predictive, Precise & Preventive Medicine for Major Depression
An observational study of Major Depressive Disorder and Persistent Depressive Disorder, run by Hannover Medical School.
Trial summary
Depressive disorders are among the most common psychiatric disorders. However, this disorder is multifaceted, as are its etiological factors, and is not yet fully understood. Within the framework of the P4D study, 1000 patients with depression will be comprehensively examined. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depressive Disorder, Persistent Depressive Disorder
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Aug 2025
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with moderate to severe depressive disorder, aged between 18 and 70 years, who are undergoing inpatient treatment will be recruited. Patients should fulfil the inclusion criteria. All patients who meet the criteria are given information by a doctor and have the opportunity to ask further questions. Their participation in the study is voluntary and they give their written informed consent.
Who may be able to join
- MDD: ICD-10: F32.1-3, F33.1-3 first or recurrent depressive episode (confirmed by MINI-DIPS) and/or PDD: F34.1
- Symptom severity: Moderate to severe (MADRS ≥ 20).
- First depressive episode before 50 years of age
- Signed informed consent form
- Capacity to consent
Who cannot join
- Acute Suicidality
- Placement according to state law (e.g. §16/17 Nds. PsychKG)
- The following diagnoses in the life course: Dementia, schizophrenia, schizoaffective disorder, bipolar disorder, substance dependence with currently necessary detoxification
- Concurrent participation in other clinical trials that are not being conducted within the framework of the P4D project
Trial locations and contacts
No sites are listed yet.
About this study
Official title: P4D - Personalized, Predictive, Precise & Preventive Medicine for Major Depression
Depressive disorders are among the most common psychiatric disorders. However, this disorder is multifaceted, as are its etiological factors, and is not yet fully understood. Within the framework of the P4D study, 1000 patients with depression will be comprehensively examined. In addition to the recording of psychological factors by means of questionnaires and third-party assessments, imaging and electrophysiological procedures (functional and structural MRI, EEG) are used to assess brain structure and function. In addition, blood is drawn from the subjects to analyze these samples for various biological markers (e.g., genetics). Drug level measurements are also performed.
The goal is to perform an in-depth characterization (phenotyping) of individuals with a depressive disorder. These findings could be used to individualize and improve therapy for depressive disorders.
- Medical subject headings
- Depressive Disorder, Major
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission after 7 weeks of treatment
The Montgomery-Asberg-Depression-Scale (MADRS) is used to measure the severity of depressive symptoms. A score lower 7 is the cut-off.
Measured: Baseline and Follow-up (Week 7)
Secondary outcomes (5)
Recording of psychometric changes in the clinical course of treatment
A range of psychometric information is collected. These include questionnaires, third party ratings and a cognitive assessment, as well as neuroimaging (functional and structural MRI), neurophysiology (EEG) and polysomnography (PSG).
Measured: Baseline and Follow-up (Week 7)
Frequency of other concomitant treatments (e.g., additional psychotherapeutic treatment)
Psychotherapy sessions (individual and group therapy) are recorded for 7 weeks. Alternative treatments (e.g. transcranial magnetic stimulation and electroconvulsive therapy) are also recorded.
Measured: Follow-up (Week 7)
Treatment/study dropout rates
Dropout rates are recorded with reasons.
Measured: Drop-out rates are collected throughout the data collection period, over two years. Starting at study enrollment of the first subject until complete completion of the last subject.
Attitudes (acceptance, fears, and prejudices) regarding biomarker-guided examinations and technical procedures among the population
Representative population survey
Measured: The survey will be conducted over a 2-week period in late August / early September 2023.
Patient-doctor relationship
The Patient-Doctor-Relationship-Questionnaire (PDRQ-9) is used to assess the quality of the therapeutic relationship.
Measured: Baseline and Follow-up (Week 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study startSep 2023 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- University Medicine Greifswald, Wuerzburg University Hospital, Goethe University, University Hospital Schleswig-Holstein
- Responsible party
- Sponsor
- Investigators
- Helge Frieling, Prof. Dr.med, Study chair, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027177
- Sponsor's protocol ID
- P4D_cohort
- Other IDs
- DRKS00032215
- Acronym
- P4D
- Status last verified
- Sep 2023
- First submitted
- 22 Aug 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing is planned.
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- P4D - Personalized, Predictive, Precise & Preventive Medicine for Major Depression
- ClinicalTrials.gov ID
- NCT06027177
- Acronym / sponsor ID
- P4D / P4D_cohort
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- University Medicine Greifswald, Wuerzburg University Hospital, Goethe University, University Hospital Schleswig-Holstein
- Study start
- Sep 2023 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 7 Sep 2023 (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.
Depressive disorders are among the most common psychiatric disorders. However, this disorder is multifaceted, as are its etiological factors, and is not yet fully understood. Within the framework of the P4D study, 1000 patients with depression will be comprehensively examined. In addition to the recording of psychological factors by means of questionnaires and third-party assessments, imaging and electrophysiological procedures (functional and structural MRI, EEG) are used to assess brain structure and function. In addition, blood is drawn from the subjects to analyze these samples for various biological markers (e.g., genetics). Drug level measurements are also performed.
The goal is to perform an in-depth characterization (phenotyping) of individuals with a depressive disorder. These findings could be used to individualize and improve therapy for depressive disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with moderate to severe depressive disorder, aged between 18 and 70 years, who are undergoing inpatient treatment will be recruited. Patients should fulfil the inclusion criteria. All patients who meet the criteria are given information by a doctor and have the opportunity to ask further questions. Their participation in the study is voluntary and they give their written informed consent.
Key inclusion criteria (5 listed)
- MDD: ICD-10: F32.1-3, F33.1-3 first or recurrent depressive episode (confirmed by MINI-DIPS) and/or PDD: F34.1
- Symptom severity: Moderate to severe (MADRS ≥ 20).
- First depressive episode before 50 years of age
- Signed informed consent form
- Capacity to consent
Key exclusion criteria (4 listed)
- Acute Suicidality
- Placement according to state law (e.g. §16/17 Nds. PsychKG)
- The following diagnoses in the life course: Dementia, schizophrenia, schizoaffective disorder, bipolar disorder, substance dependence with currently necessary detoxification
- Concurrent participation in other clinical trials that are not being conducted within the framework of the P4D project
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Remission after 7 weeks of treatment
Time frame: Baseline and Follow-up (Week 7)
The Montgomery-Asberg-Depression-Scale (MADRS) is used to measure the severity of depressive symptoms. A score lower 7 is the cut-off.
5 secondary outcomes
Recording of psychometric changes in the clinical course of treatment
Time frame: Baseline and Follow-up (Week 7)
Frequency of other concomitant treatments (e.g., additional psychotherapeutic treatment)
Time frame: Follow-up (Week 7)
Treatment/study dropout rates
Time frame: Drop-out rates are collected throughout the data collection period, over two years. Starting at study enrollment of the first subject until complete completion of the last subject.
Attitudes (acceptance, fears, and prejudices) regarding biomarker-guided examinations and technical procedures among the population
Time frame: The survey will be conducted over a 2-week period in late August / early September 2023.
Patient-doctor relationship
Time frame: Baseline and Follow-up (Week 7)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: Yes. Data sharing is planned.
Related trials for Major Depressive Disorder
Not yet recruitingObservational study
Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
Mood Disorders, Major Depressive Diorder
RecruitingPhase 3
A Study of Vortioxetine in Japanese Pediatric Patients With Major Depressive Disorder
Major Depressive Disorder
RecruitingPhase 1
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
Healthy Volunteer, Major Depressive Disorder
Recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
Recruiting
Ketogenic Diet and Neuromodulation in Treatment Resistant Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)
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.
Helge Frieling, Prof. Dr.med study chair
Hannover Medical School
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder and Persistent Depressive Disorder, run by Hannover Medical School.
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 5 inclusion and 4 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 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Helge Frieling, Prof. Dr.med (+49 511 532-2427, frieling.helge@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission after 7 weeks of treatment (time frame: Baseline and Follow-up (Week 7)). 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 7 Sep 2023.