Biological Classification of Mental Disorders

NCT03984084 | Unknown

• 1 other identifier: 350-14
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mental Disorder; Depressive Disorder; Anxiety; Trauma and Stressor Related Disorders

Keywords

biomarkers; translational medical research; psychiatry; Research Domain Criteria (RDoC); omics; neuroimaging; taxonomy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  cross-sectional (baseline)

Other Outcomes (8)

• Stability/change in methylation over time

  baseline and at days 14, 28 and 56 after baseline

• Stability/change in body mass index (BMI) over time

  baseline and at day 56 after baseline

• Stability/change in blood pressure over time

  baseline and at days 14, 28 and 56 after baseline

Study Arms (2)

externally recruited participants

Self-referred affected and non-affected participants responding to advertisements

Other: no intervention

In-house patients

Patients seeking treatment in the outpatient clinic of the Max-Planck-institute of Psychiatry

Other: no intervention

Interventions

no intervention OTHER

no intervention

In-house patients; externally recruited participants

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

individuals with varying degrees and a broad range of mental disorders from the anxiety and depression spectrum

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Max-Planck-Institute of Psychiatry: lead

Study Sites (1)

Max Planck Institute of Psychiatry

Munich, Bavaria, 80804, Germany

RECRUITING

Related Publications (2)

• 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.

  PMID: 37087709 DERIVED

• Bruckl 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.

  PMID: 32393358 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood and saliva

MeSH Terms

Conditions

Mental Disorders; Depressive Disorder; Anxiety Disorders; Trauma and Stressor Related Disorders

Condition Hierarchy (Ancestors)

Mood Disorders

Study Officials

• Elisabeth B Binder, Prof. Dr. Dr.

  Max-Planck-Institute of Psychiatry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisabeth B Binder, Prof. Dr. Dr.

CONTACT

+49 (0) 89-30622-586; binder@psych.mpg.de

Tanja M Brückl, PhD

CONTACT

+49 (0) 89-30622-554; brueckl@psych.mpg.de

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: June 12, 2019
• Study Start: June 9, 2015
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 19, 2023

Record last verified: 2023-10

Locations

DE (1)