Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders

Phase 4

Completed

• Conditions: Anxiety Disorder; Major Depressive Disorder (MDD)
• Interventions: Drug: Escitalopram

• Registration Number: NCT01477203
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-15
• Study First Submitted QC: 2011-11-18
• Study First Posted: 2011-11-22
• Status Verified: 2016-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-13
• Last Update Posted: 2016-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 289

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
biochemical data	4 years	these include steroid hormone levels, vitamins, etc.

Trial Locations

Locations (1)

Medical University of Vienna, Department for Psychiatrie and Psychotherapie; 🇦🇹 Vienna, Austria