Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders

Study Overview
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Brief Summary
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MAN-BIOPSY pursues the concrete research question whether novel biological and psycho-physiological clusters or categories can be defined to improve treatment and minimize side effects in psychiatry, based on a synopsis of physiological, behavioural, genetic and endocrinological parameters. One major aspect of our research approach is its focuses on the identification of dysfunctions in fundamental information processing mechanisms and neurocomputational mechanisms, and is not restricted to symptom-oriented tasks. The main objectives of MAN-BIOPSY are therefore to identify biological and psycho-physiological parameters for major depressive disorders and anxiety disorders, and to identify predictive markers for treatment response and type/severity of side effects for these disorders.

Official Title
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Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders

Conditions
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Major Depressive Disorder (MDD), Anxiety Disorder

Intervention / Treatment
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* Drug: Escitalopram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for patients: DSM-IV-TR diagnosis of MDD or an anxiety disorder (excluding PTSD, specific phobias, and bipolar disorder) by a structured clinical interview (SCID) aged 18 to 50 years drug-free within the last three months prior inclusion willingness and competence to sign the informed consent form Inclusion Criteria for remitted subjects: a previous DSM-IV-TR diagnosis of MDD or an anxiety disorder (excluding PTSD, specific phobias, and bipolar disorder) but no symptoms at present, determined by SCID aged 18-50 years drug-free within the last three months prior inclusion willingness and competence to sign the informed consent form Inclusion Criteria for healthy control subjects: Inclusion criteria for healthy control subjects are willingness and competence to sign the informed consent form aged 18-50 years drug-free Exclusion Criteria: concomitant major internal or neurological illness concomitant psychiatric disorders (except depression and anxiety for patients, excluding PTSD, claustrophobia and bipolar disorder) ingestion of any antipsychotic, antidepressant, or anti-anxiety agent within the last three months prior to the screening visit current substance abuse failure to comply with the study protocol or to follow the instructions of the investigating team

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Escitalopram<br>50 Major Depressive Disorder Patients and 50 Anxiety Disorder Patients will receive Escitalopram as medication | Drug: Escitalopram<br>* 2-4 weeks, 5-10mg, max 20mg<br>|
| No Intervention: Remitted Patients<br> | |
| No Intervention: Healthy Controls<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SSRI induced changes in BOLD (blood oxygen level dependent) response over time |  | 4 vears | 
| SSRI induced changes in ERPs (event-related potentials) over time |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biochemical data | these include steroid hormone levels, vitamins, etc. | 4 years |