xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06027177</url>
    </required_header>
    <id_info>
      <org_study_id>P4D_cohort</org_study_id>
      <secondary_id>DRKS00032215</secondary_id>
      <nct_id>NCT06027177</nct_id>
    </id_info>
    <brief_title>Personalized, Predictive, Precise &amp; Preventive Medicine for Major Depression</brief_title>
    <acronym>P4D</acronym>
    <official_title>P4D - Personalized, Predictive, Precise &amp; Preventive Medicine for Major Depression</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hannover Medical School</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University Medicine Greifswald</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Wuerzburg University Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Goethe University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University Hospital Schleswig-Holstein</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Hannover Medical School</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Depressive disorders are among the most common psychiatric disorders. However, this disorder&#xD;
        is multifaceted, as are its etiological factors, and is not yet fully understood. Within the&#xD;
        framework of the P4D study, 1000 patients with depression will be comprehensively examined.&#xD;
        In addition to the recording of psychological factors by means of questionnaires and&#xD;
        third-party assessments, imaging and electrophysiological procedures (functional and&#xD;
        structural MRI, EEG) are used to assess brain structure and function. In addition, blood is&#xD;
        drawn from the subjects to analyze these samples for various biological markers (e.g.,&#xD;
        genetics). Drug level measurements are also performed.&#xD;
  &#xD;
        The goal is to perform an in-depth characterization (phenotyping) of individuals with a&#xD;
        depressive disorder. These findings could be used to individualize and improve therapy for&#xD;
        depressive disorders.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">August 2025</completion_date>
    <primary_completion_date type="Anticipated">August 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Remission after 7 weeks of treatment</measure>
      <time_frame>Baseline and Follow-up (Week 7)</time_frame>
      <description>The Montgomery-Asberg-Depression-Scale (MADRS) is used to measure the severity of depressive symptoms. A score lower 7 is the cut-off.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Recording of psychometric changes in the clinical course of treatment</measure>
      <time_frame>Baseline and Follow-up (Week 7)</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Frequency of other concomitant treatments (e.g., additional psychotherapeutic treatment)</measure>
      <time_frame>Follow-up (Week 7)</time_frame>
      <description>Psychotherapy sessions (individual and group therapy) are recorded for 7 weeks. Alternative treatments (e.g. transcranial magnetic stimulation and electroconvulsive therapy) are also recorded.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment/study dropout rates</measure>
      <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.</time_frame>
      <description>Dropout rates are recorded with reasons.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Attitudes (acceptance, fears, and prejudices) regarding biomarker-guided examinations and technical procedures among the population</measure>
      <time_frame>The survey will be conducted over a 2-week period in late August / early September 2023.</time_frame>
      <description>Representative population survey</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient-doctor relationship</measure>
      <time_frame>Baseline and Follow-up (Week 7)</time_frame>
      <description>The Patient-Doctor-Relationship-Questionnaire (PDRQ-9) is used to assess the quality of the therapeutic relationship.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Major Depressive Disorder</condition>
    <condition>Persistent Depressive Disorder</condition>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood samples are used for a variety of purposes. In addition to standard clinical laboratory&#xD;
        tests, genetic (nanopore sequencing) and epigenetic (miRNA, methylation) tests will be&#xD;
        performed. In addition, drug levels will be monitored regularly.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with moderate to severe depressive disorder, aged between 18 and 70 years, who are&#xD;
          undergoing inpatient treatment will be recruited. Patients should fulfil the inclusion&#xD;
          criteria. All patients who meet the criteria are given information by a doctor and have the&#xD;
          opportunity to ask further questions. Their participation in the study is voluntary and&#xD;
          they give their written informed consent.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  MDD: ICD-10: F32.1-3, F33.1-3 first or recurrent depressive episode (confirmed by&#xD;
               MINI-DIPS) and/or PDD: F34.1&#xD;
  &#xD;
            -  Symptom severity: Moderate to severe (MADRS ≥ 20).&#xD;
  &#xD;
            -  First depressive episode before 50 years of age&#xD;
  &#xD;
            -  Signed informed consent form&#xD;
  &#xD;
            -  Capacity to consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Acute Suicidality&#xD;
  &#xD;
            -  Placement according to state law (e.g. §16/17 Nds. PsychKG)&#xD;
  &#xD;
            -  The following diagnoses in the life course: Dementia, schizophrenia, schizoaffective&#xD;
               disorder, bipolar disorder, substance dependence with currently necessary&#xD;
               detoxification&#xD;
  &#xD;
            -  Concurrent participation in other clinical trials that are not being conducted within&#xD;
               the framework of the P4D project&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Helge Frieling, Prof. Dr.med</last_name>
      <role>Study Chair</role>
      <affiliation>Hannover Medical School</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Helge Frieling, Prof. Dr.med</last_name>
      <phone>+49 511 532-2427</phone>
      <email>frieling.helge@mh-hannover.de</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Hannah B Maier, Dr. med.</last_name>
      <phone>+49 176 1532-8329</phone>
      <email>maier.hannah@mh-hannover.de</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
      <mesh_term>Depressive Disorder</mesh_term>
      <mesh_term>Depressive Disorder, Major</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Data sharing is planned.</ipd_description>
      <ipd_time_frame>Data will be kept pseudonymised for 10 years and then anonymised.</ipd_time_frame>
      <ipd_access_criteria>Upon individual request, data may be made available before this time.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06027177
  org study id: P4D_cohort
  secondary id: DRKS00032215
  nct id: NCT06027177
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  observational model: Cohort
  time perspective: Prospective
  measure: Remission after 7 weeks of treatment
  time frame: Baseline and Follow-up (Week 7)
  description: The Montgomery-Asberg-Depression-Scale (MADRS) is used to measure the severity of depressive symptoms. A score lower 7 is the cut-off.
  measure: Recording of psychometric changes in the clinical course of treatment
  time frame: Baseline and Follow-up (Week 7)
  description: 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).
  measure: Frequency of other concomitant treatments (e.g., additional psychotherapeutic treatment)
  time frame: Follow-up (Week 7)
  description: Psychotherapy sessions (individual and group therapy) are recorded for 7 weeks. Alternative treatments (e.g. transcranial magnetic stimulation and electroconvulsive therapy) are also recorded.
  measure: 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.
  description: Dropout rates are recorded with reasons.
  measure: 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.
  description: Representative population survey
  measure: Patient-doctor relationship
  time frame: Baseline and Follow-up (Week 7)
  description: The Patient-Doctor-Relationship-Questionnaire (PDRQ-9) is used to assess the quality of the therapeutic relationship.
  Blood samples are used for a variety of purposes. In addition to standard clinical laboratory
        tests, genetic (nanopore sequencing) and epigenetic (miRNA, methylation) tests will be
        performed. In addition, drug levels will be monitored regularly.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Helge Frieling, Prof. Dr.med
  role: Study Chair
  affiliation: Hannover Medical School
  last name: Helge Frieling, Prof. Dr.med
  phone: +49 511 532-2427
  email: frieling.helge@mh-hannover.de
  last name: Hannah B Maier, Dr. med.
  phone: +49 176 1532-8329
  email: maier.hannah@mh-hannover.de
  responsible party type: Sponsor
  mesh term: Depression
  mesh term: Depressive Disorder
  mesh term: Depressive Disorder, Major
  sharing ipd: Yes
  ipd description: Data sharing is planned.
  ipd time frame: Data will be kept pseudonymised for 10 years and then anonymised.
  ipd access criteria: Upon individual request, data may be made available before this time.