Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders (MAN-BIOPSY)

September 13, 2016 updated by: Rupert Lanzenberger, Medical University of Vienna

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

289

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna, Department for Psychiatrie and Psychotherapie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Healthy Controls
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

November 15, 2011

First Submitted That Met QC Criteria

November 18, 2011

First Posted (Estimate)

November 22, 2011

Study Record Updates

Last Update Posted (Estimate)

September 14, 2016

Last Update Submitted That Met QC Criteria

September 13, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FA103FC001
  • 2011-004860-31 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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