Anxiety Clinical Trial
— BeCOMEOfficial title:
The Biological Classification of Mental Disorders Study: Towards a New Taxonomy of Mental Disorders
NCT number | NCT03984084 |
Other study ID # | 350-14 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 9, 2015 |
Est. completion date | December 31, 2025 |
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.
Status | Recruiting |
Enrollment | 1500 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Germany | Max Planck Institute of Psychiatry | Munich | Bavaria |
Lead Sponsor | Collaborator |
---|---|
Max-Planck-Institute of Psychiatry |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | baseline and at days 14, 28 and 56 after baseline | |
Other | 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 | baseline and at day 56 after baseline | |
Other | 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. | baseline and at days 14, 28 and 56 after baseline | |
Other | 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. | baseline and at days 14, 28 and 56 after baseline | |
Other | 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 | baseline and every follow-up assessment: day 14, 28 and 56 as well as 4 and 12 months after baseline) | |
Other | 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 | baseline and every follow-up assessment: day 14, 28 and 56 as well as 4 and 12 months after baseline) | |
Other | 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 | baseline and every follow-up assessment: day 14, 28 and 56 as well as 4 and 12 months after baseline) | |
Other | 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. | baseline and every follow-up assessment: day 14, 28 and 56 as well as 4 and 12 months after baseline) | |
Primary | 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) | |
Primary | 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) |
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