Mental DisorderBeCOMENCT03984084
Biological Classification of Mental Disorders
An observational study of Mental Disorder and Depressive Disorder, run by Max-Planck-Institute of Psychiatry at 1 site in Germany.
Trial summary
BeCOME intends to include at least 1000 individuals with a broad spectrum of affective, anxiety and stress-related mental disorders as well as 500 individuals unaffected by mental disorders. After a screening visit, all participants undergo in-depth phenotyping procedures and omics assessments on two consecutive days. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Disorder, Depressive Disorder, Anxiety
- How many people
- 1,500 participants
- Where
- 1 siteGermany
- Study dates
- 9 Jun 2015to 31 Dec 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: individuals with varying degrees and a broad range of mental disorders from the anxiety and depression spectrum
Who may be able to join
- Presence of an affective, anxiety or stress-related mental disorder according to the criteria of DSM-IV or DSM-5 (Depressive disorders;Anxiety and obsessive-compulsive disorders: agoraphobia with and without panic disorder, panic disorder, social phobia, specific phobia, generalized anxiety disorder, obsessive compulsive disorder; Stress and trauma-associated mental disorders (e.g. posttraumatic stress disorder).
- or no mental disorder
Who cannot join
- Intake of any psychotropic medication/substance for a minimum of 2 months before study day 1.
- Current illness in the field of organic mental disorders;
- Affective disorders caused by a medical condition
- Organic mental disorders (e.g. dementia)
- Current disorders of schizophrenia;
- Current eating disorder;
Show all 16Show fewer
- Mental retardation and profound developmental disorders;
- Severe neurological or internal medical illness;
- Posttraumatic or post-ischemic brain damage or elapsed cerebral hemorrhage;
- Acute suicidality;
- Pregnancy and postpartum period;
- Magnetic resonance imaging contraindications (e.g. non-MR compatible metal implants including cardiac pacemakers, claustrophobia);
- Myopia <-6 D, which cannot be compensated by contact lenses or MR compatible glasses (Cambridge Research Systems, Rochester, UK);
- Current substance abuse;
- Current or past substance dependence;
- Risky alcohol consumption, screened with the Alcohol Use Disorder Identification Test - Consumption questions (AUDIT-C) and defined as score of ≥5 in males and of ≥4 in females.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Max Planck Institute of Psychiatry
Munich, Bavaria, 80804
Elisabeth B Binder, Prof. Dr. Dr., +49 (0) 89-30622-586, binder@psych.mpg.de
About this study
Official title: The Biological Classification of Mental Disorders Study: Towards a New Taxonomy of Mental Disorders
BeCOME intends to include at least 1000 individuals with a broad spectrum of affective, anxiety and stress-related mental disorders as well as 500 individuals unaffected by mental disorders. After a screening visit, all participants undergo in-depth phenotyping procedures and omics assessments on two consecutive days. Several validated paradigms (e.g., fear conditioning, reward anticipation, imaging stress test) are applied to stimulate a response in a basic system of human functioning (e.g., acute threat response, reward processing, stress response) that plays a key role in the development of affective, anxiety and stress-related mental disorders. The response to this stimulation is then read out across multiple levels. Assessments comprise omics, physiological, neuroimaging, neurocognitive, psychophysiological and psychometric measurements. The multilevel information collected in BeCOME will be used to identify data-driven biologically-informed categories of mental disorders using cluster analytical techniques. A subgroup of affected individuals (patients of the outpatients clinic of the Max Planck Institute of Psychiatry) are longitudinally observed regarding the stability of omics markers, vital parameters and symptom severity.
Read the detailed description
Background:
A major research finding in the field of Biological Psychiatry is that symptom-based categories of mental disorders map poorly onto dysfunctions in brain circuits or neurobiological pathways. Many of the identified (neuro)biological dysfunctions are "transdiagnostic", meaning that they do not reflect diagnostic boundaries but are shared by different ICD/DSM diagnoses. The compromised biological validity of the current classification system for mental disorders impedes rather than supports the development of treatments that not only target symptoms but also the underlying pathophysiological mechanisms. The Biological Classification of Mental Disorders (BeCOME) study aims to identify biology-based classes of mental disorders that improve the translation of novel biomedical findings into tailored clinical applications.
Methods:
BeCOME intends to include at least 1000 affected individuals (recruited through advertisements/self-referral or visits in the institute's outpatient clinic or in collaborating practices) with a broad spectrum of affective, anxiety and stress-related mental disorders as well as 500 individuals unaffected by mental disorders (advertisements/self-referral). After a screening visit, all participants undergo in-depth phenotyping procedures and omics assessments on two consecutive days. Several validated paradigms (e.g., fear conditioning, reward anticipation, imaging stress test) are applied to stimulate a response in a basic system of human functioning (e.g., acute threat response, reward processing, stress response) that plays a key role in the development of affective, anxiety and stress-related mental disorders. The response to this stimulation is then read out across multiple levels. Assessments comprise omics, physiological, neuroimaging, neurocognitive, psychophysiological and psychometric measurements. The multilevel information collected in BeCOME will be used to identify data-driven biologically-informed categories of mental disorders using cluster analytical techniques. Moreover, the subgroup of patients from the outpatient clinic of the Max Planck Institute of Psychiatry is followed-up at study days 14, 28 and 56 as well as 4 and 12 months after baseline for changes in a subset of parameters (omics, vital parameters and selected psychometric measures).
Discussion:
The novelty of BeCOME lies in the dynamic in-depth phenotyping and omics characterization of individuals with mental disorders from the depression and anxiety spectrum of varying severity. The investigators believe that such biology-based subclasses of mental disorders will serve as better treatment targets than purely symptom-based disease entities, and help in tailoring the right treatment to the individual patient suffering from a mental disorder. BeCOME has the potential to contribute to a novel taxonomy of mental disorders that integrates the underlying pathomechanisms into diagnoses.
- Being tested
- no intervention
- Keywords
- biomarkers, translational medical research, psychiatry, Research Domain Criteria (RDoC), omics, neuroimaging, taxonomy
- Medical subject headings
- Mental Disorders, Depressive Disorder, Anxiety Disorders, Trauma and Stressor Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| externally recruited participants | Self-referred affected and non-affected participants responding to advertisements Receives: Other: no intervention | |
| In-house patients | Patients seeking treatment in the outpatient clinic of the Max-Planck-institute of Psychiatry Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of data-driven biologically-informed categories ("biotypes") of anxiety, depressive and stress-related mental disorders
The study is exploratory. Following an Research Domain Criteria (RDoC) approach, the study will use multi-level information for clustering of patients anxiety, depressive and stress-related mental disorders.
Measured: cross-sectional (baseline)
Comparison of the new biotypes (biological classification approach) to traditional symptom-based diagnostic categories (DIA-X/M-CIDI)
Assessment of anxiety, depressive and stress-related disorders using the diagnostic interview (computerized Munich version of the Composite International Diagnostic Interview, DIA-X/M-CIDI) according to the traditional classification approach in order to assess the distribution of "biotypes" across traditional diagnostic categories of affective and anxiety disorders.
Measured: cross-sectional (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start9 Jun 2015
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental 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
- Other
- Time perspective
- Other
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Max-Planck-Institute of Psychiatry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth B Binder, Prof. Dr. Dr., Principal investigator, Max-Planck-Institute of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984084
- Sponsor's protocol ID
- 350-14
- Acronym
- BeCOME
- Status last verified
- Oct 2023
- First submitted
- 24 May 2019
- Last updated
- 19 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sun R, Fietz J, Erhart M, Poehlchen D, Henco L, Bruckl TM; BeCOME study team; Czisch M, Saemann PG, Spoormaker VI. Free-viewing gaze patterns reveal a mood-congruency bias in MDD during an affective fMRI/eye-tracking task. Eur Arch Psychiatry Clin Neurosci. 2024 Apr;274(3):559-571. doi: 10.1007/s00406-023-01608-8. Epub 2023 Apr 23.
PubMed 37087709Bruckl TM, Spoormaker VI, Samann PG, Brem AK, Henco L, Czamara D, Elbau I, Grandi NC, Jollans L, Kuhnel A, Leuchs L, Pohlchen D, Schneider M, Tontsch A, Keck ME, Schilbach L, Czisch M, Lucae S, Erhardt A, Binder EB. The biological classification of mental disorders (BeCOME) study: a protocol for an observational deep-phenotyping study for the identification of biological subtypes. BMC Psychiatry. 2020 May 11;20(1):213. doi: 10.1186/s12888-020-02541-z.
PubMed 32393358
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Biological Classification of Mental Disorders Study: Towards a New Taxonomy of Mental Disorders
- ClinicalTrials.gov ID
- NCT03984084
- Acronym / sponsor ID
- BeCOME / 350-14
- Keywords
- biomarkers, translational medical research, psychiatry, Research Domain Criteria (RDoC), omics, neuroimaging, taxonomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Max-Planck-Institute of PsychiatryUniversity, hospital or other
- Study start
- 9 Jun 2015 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Jun 2019 (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.
BeCOME intends to include at least 1000 individuals with a broad spectrum of affective, anxiety and stress-related mental disorders as well as 500 individuals unaffected by mental disorders. After a screening visit, all participants undergo in-depth phenotyping procedures and omics assessments on two consecutive days. Several validated paradigms (e.g., fear conditioning, reward anticipation, imaging stress test) are applied to stimulate a response in a basic system of human functioning (e.g., acute threat response, reward processing, stress response) that plays a key role in the development of affective, anxiety and stress-related mental disorders. The response to this stimulation is then read out across multiple levels. Assessments comprise omics, physiological, neuroimaging, neurocognitive, psychophysiological and psychometric measurements. The multilevel information collected in BeCOME will be used to identify data-driven biologically-informed categories of mental disorders using cluster analytical techniques. A subgroup of affected individuals (patients of the outpatients clinic of the Max Planck Institute of Psychiatry) are longitudinally observed regarding the stability of omics markers, vital parameters and symptom severity.
Detailed description
Background:
A major research finding in the field of Biological Psychiatry is that symptom-based categories of mental disorders map poorly onto dysfunctions in brain circuits or neurobiological pathways. Many of the identified (neuro)biological dysfunctions are "transdiagnostic", meaning that they do not reflect diagnostic boundaries but are shared by different ICD/DSM diagnoses. The compromised biological validity of the current classification system for mental disorders impedes rather than supports the development of treatments that not only target symptoms but also the underlying pathophysiological mechanisms. The Biological Classification of Mental Disorders (BeCOME) study aims to identify biology-based classes of mental disorders that improve the translation of novel biomedical findings into tailored clinical applications.
Methods:
BeCOME intends to include at least 1000 affected individuals (recruited through advertisements/self-referral or visits in the institute's outpatient clinic or in collaborating practices) with a broad spectrum of affective, anxiety and stress-related mental disorders as well as 500 individuals unaffected by mental disorders (advertisements/self-referral). After a screening visit, all participants undergo in-depth phenotyping procedures and omics assessments on two consecutive days. Several validated paradigms (e.g., fear conditioning, reward anticipation, imaging stress test) are applied to stimulate a response in a basic system of human functioning (e.g., acute threat response, reward processing, stress response) that plays a key role in the development of affective, anxiety and stress-related mental disorders. The response to this stimulation is then read out across multiple levels. Assessments comprise omics, physiological, neuroimaging, neurocognitive, psychophysiological and psychometric measurements. The multilevel information collected in BeCOME will be used to identify data-driven biologically-informed categories of mental disorders using cluster analytical techniques. Moreover, the subgroup of patients from the outpatient clinic of the Max Planck Institute of Psychiatry is followed-up at study days 14, 28 and 56 as well as 4 and 12 months after baseline for changes in a subset of parameters (omics, vital parameters and selected psychometric measures).
Discussion:
The novelty of BeCOME lies in the dynamic in-depth phenotyping and omics characterization of individuals with mental disorders from the depression and anxiety spectrum of varying severity. The investigators believe that such biology-based subclasses of mental disorders will serve as better treatment targets than purely symptom-based disease entities, and help in tailoring the right treatment to the individual patient suffering from a mental disorder. BeCOME has the potential to contribute to a novel taxonomy of mental disorders that integrates the underlying pathomechanisms into diagnoses.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| externally recruited participants | – | Other: no interventionSelf-referred affected and non-affected participants responding to advertisements |
| In-house patients | – | Other: no interventionPatients seeking treatment in the outpatient clinic of the Max-Planck-institute of Psychiatry |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- individuals with varying degrees and a broad range of mental disorders from the anxiety and depression spectrum
Key inclusion criteria (2 listed)
- Presence of an affective, anxiety or stress-related mental disorder according to the criteria of DSM-IV or DSM-5 (Depressive disorders;Anxiety and obsessive-compulsive disorders: agoraphobia with and without panic disorder, panic disorder, social phobia, specific phobia, generalized anxiety disorder, obsessive compulsive disorder; Stress and trauma-associated mental disorders (e.g. posttraumatic stress disorder).
- or no mental disorder
Key exclusion criteria (16 listed)
- Intake of any psychotropic medication/substance for a minimum of 2 months before study day 1.
- Current illness in the field of organic mental disorders;
- Affective disorders caused by a medical condition
- Organic mental disorders (e.g. dementia)
- Current disorders of schizophrenia;
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 |
|---|---|---|
| no interventionno intervention | Other | In-house patients, externally recruited participants |
Primary outcome
Identification of data-driven biologically-informed categories ("biotypes") of anxiety, depressive and stress-related mental disorders
Time frame: cross-sectional (baseline)
The study is exploratory. Following an Research Domain Criteria (RDoC) approach, the study will use multi-level information for clustering of patients anxiety, depressive and stress-related mental disorders.
Comparison of the new biotypes (biological classification approach) to traditional symptom-based diagnostic categories (DIA-X/M-CIDI)
Time frame: cross-sectional (baseline)
Assessment of anxiety, depressive and stress-related disorders using the diagnostic interview (computerized Munich version of the Composite International Diagnostic Interview, DIA-X/M-CIDI) according to the traditional classification approach in order to assess the distribution of "biotypes" across traditional diagnostic categories of affective and anxiety disorders.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Derived from this study: PubMed 37087709Sun R, Fietz J, Erhart M, Poehlchen D, Henco L, Bruckl TM; BeCOME study team; Czisch M, Saemann PG, Spoormaker VI. Free-viewing gaze patterns reveal a mood-congruency bias in MDD during an affective fMRI/eye-tracking task. Eur Arch Psychiatry Clin Neurosci. 2024 Apr;274(3):559-571. doi: 10.1007/s00406-023-01608-8. Epub 2023 Apr 23.
- Derived from this study: PubMed 32393358Bruckl TM, Spoormaker VI, Samann PG, Brem AK, Henco L, Czamara D, Elbau I, Grandi NC, Jollans L, Kuhnel A, Leuchs L, Pohlchen D, Schneider M, Tontsch A, Keck ME, Schilbach L, Czisch M, Lucae S, Erhardt A, Binder EB. The biological classification of mental disorders (BeCOME) study: a protocol for an observational deep-phenotyping study for the identification of biological subtypes. BMC Psychiatry. 2020 May 11;20(1):213. doi: 10.1186/s12888-020-02541-z.
- 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.
Elisabeth B Binder, Prof. Dr. Dr. principal investigator
Max-Planck-Institute of Psychiatry
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 Mental Disorder and Depressive Disorder, run by Max-Planck-Institute of Psychiatry 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 2 inclusion and 16 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 19 Oct 2023. 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 Elisabeth B Binder, Prof. Dr. Dr. (+49 (0) 89-30622-586, binder@psych.mpg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of data-driven biologically-informed categories ("biotypes") of anxiety, depressive and stress-related mental disorders (time frame: cross-sectional (baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03984084, which also lists 2 linked publications.
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 19 Oct 2023.