An observational study in Mental Disorder, Depressive Disorder and Anxiety, sponsored by Max-Planck-Institute of Psychiatry. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-19.
Sponsored by Max-Planck-Institute of Psychiatry · Observational
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.
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.
1,740 studies on the registry are indexed under Mental Disorders; 348 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 220 across 389 observational studies indexed under Mental Disorders.
Browse Mental Disorders studies →Max-Planck-Institute of Psychiatry is the lead sponsor of 19 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
individuals with varying degrees and a broad range of mental disorders from the anxiety and depression spectrum
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Self-referred affected and non-affected participants responding to advertisements
Other: no intervention
Patients seeking treatment in the outpatient clinic of the Max-Planck-institute of Psychiatry
Other: no intervention
no intervention
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.
Time frame: 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.
Time frame: cross-sectional (baseline)
Stability/change in methylation over time
longitudinal analysis only in patients who are treated at the MPIP (group 2), DNA extraction from blood for the determination of epigenetic markers (DNA methylation) for the determination of the stability of methylation patterns from baseline up to study day 56.
Time frame: baseline and at days 14, 28 and 56 after baseline
Stability/change in body mass index (BMI) over time
longitudinal analysis only in patients who are treated at the MPIP (group 2), comparison of body mass index (BMI, calculated as kg/m\^2) at study day 56 to body mass index at baseline
Time frame: baseline and at day 56 after baseline
Stability/change in blood pressure over time
longitudinal analysis only in patients who are treated at the MPIP (group 2), changes of blood pressure between baseline and study day 56.
Time frame: baseline and at days 14, 28 and 56 after baseline
Stability/change in gene expression over time
longitudinal analysis only in patients who are treated at the MPIP (group 2), messenger RNA extraction from blood for the determination of changes in gene expression from study day 1 up to study day 56.
Time frame: baseline and at days 14, 28 and 56 after baseline
Stability/change in BDI-II (Beck-Depression-Inventory-II) sum score
longitudinal analysis only in patients who are treated at the MPIP (group 2), Beck depression inventory, revised version (BDI-II) will be used for the assessment of changes in depression severity (indicated by the sum score, range from 0 to 63) from study day 1 up to 12 months after study day 1
Time frame: baseline and every follow-up assessment: day 14, 28 and 56 as well as 4 and 12 months after baseline)
Stability/change in the Montgomery Asberg Depression Scale (MADRS) sum score
longitudinal analysis only in patients who are treated at the MPIP (group 2), the observer-based Montgomery Asberg Depression Scale (MADRS) will be used for the assessment of changes in MADRS depression sum score (range from 0 to 60) from study day 1 up to 12 months after study day 1
Time frame: baseline and every follow-up assessment: day 14, 28 and 56 as well as 4 and 12 months after baseline)
Stability/change in the state scale of the Spielberger State-Trait Anxiety Inventory (STAI)
longitudinal analysis only in patients who are treated at the MPIP (group 2), the sum score of the state scale of the STAI (range from 20 to 80) will be used for the assessment of changes in state anxiety from study day 1 up to 12 months after study day 1
Time frame: baseline and every follow-up assessment: day 14, 28 and 56 as well as 4 and 12 months after baseline)
Stability/change in the Panic and Agoraphobia Scale (PAS) score over time
longitudinal analysis only in patients who are treated at the MPIP (group 2), the sum score of Panic and Agoraphobia Scale (PAS), range from 0 to 65, will be used for the assessment of changes in the severity of panic and agoraphobia.
Time frame: baseline and every follow-up assessment: day 14, 28 and 56 as well as 4 and 12 months after baseline)
Plan to share: Undecided
Started Jun 2015 (actual). Primary completion is estimated for Dec 2025, 126 months after the start.
Of 149 non-industry observational studies under Mental Disorders, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 77. This study's planned 126 months is above that.
Counting every sponsor, half of 156 studies reached it within 37 months; a quarter within 13 and three quarters within 77.
Mental Disorders covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Max-Planck-Institute of Psychiatry