MAN-BIOPSY: Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT01477203

Collaborator

(none)

289

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder (MDD) Anxiety Disorder	Drug: Escitalopram	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

289 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Sep 1, 2016

Actual Study Completion Date :

Sep 1, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Escitalopram

50 Major Depressive Disorder Patients and 50 Anxiety Disorder Patients will receive Escitalopram as medication

Drug: Escitalopram

2-4 weeks, 5-10mg, max 20mg

No Intervention: Remitted Patients

No Intervention: Healthy Controls

Outcome Measures

Primary Outcome Measures

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

biochemical data [4 years]
these include steroid hormone levels, vitamins, etc.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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