Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders

Anxiety Disorder Clinical Trial

— MAN-BIOPSY  

Official title:

Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01477203
• Other study ID #: FA103FC001
• Secondary ID: 2011-004860-31
• Status: Completed
• Phase: Phase 4
• First received: November 15, 2011
• Last updated: September 13, 2016
• Start date: November 2011
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyPharmMed - Medicinal Products and Medical Devices: AustriaAGES - Austrian Agency for Health & Food Safety: Austria
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 289
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder (MDD)
• Mental Disorders
• Problem Behavior

Intervention

Drug:
• Escitalopram
2-4 weeks, 5-10mg, max 20mg

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Department for Psychiatrie and Psychotherapie	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SSRI induced changes in BOLD (blood oxygen level dependent) response over time		4 vears	No
Primary	SSRI induced changes in ERPs (event-related potentials) over time		4 years	No
Secondary	biochemical data	these include steroid hormone levels, vitamins, etc.	4 years	No

External Links

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