Identifying biological categories of mental disorders

The Biological Classification of Mental Disorders Study: Towards a New Taxonomy of Mental Disorders

This study is trying to find biological differences in people with mental disorders and those without to help improve understanding and treatment of these conditions.

Quick facts

• Study type: Observational
• Enrollment: 1500 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Max-Planck-Institute of Psychiatry (other)
• Locations: 1 site (Munich, Bavaria)
• Trial ID: NCT03984084 on ClinicalTrials.gov

What this trial studies

The BeCOME project aims to include over 1000 individuals with various mental disorders and 500 unaffected individuals to explore biological classifications of mental health conditions. Participants will undergo extensive assessments, including omics evaluations and neuroimaging, to stimulate and measure responses related to stress, reward, and threat. This observational study seeks to uncover biologically-informed categories that could enhance the understanding and treatment of mental disorders. By utilizing validated paradigms, the study will gather multi-level data to inform future clinical applications.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with affective, anxiety, or stress-related mental disorders, as well as those without any mental disorders.

Not a fit: Patients with severe neurological conditions, organic mental disorders, or those currently on psychotropic medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate classifications and targeted treatments for mental disorders based on biological mechanisms.

How similar studies have performed: While there have been studies exploring biological classifications of mental disorders, this approach is innovative in its comprehensive use of omics and multi-level assessments.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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;
* 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.

Where this trial is running

Munich, Bavaria

• Max Planck Institute of Psychiatry — Munich, Bavaria, Germany (RECRUITING)

Study contacts

• Principal investigator: Elisabeth B Binder, Prof. Dr. Dr. — Max-Planck-Institute of Psychiatry
• Study coordinator: Elisabeth B Binder, Prof. Dr. Dr.

Conditions: Mental Disorder, Depressive Disorder, Anxiety, Trauma and Stressor Related Disorders, biomarkers, translational medical research, psychiatry, Research Domain Criteria