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

This study is currently recruiting participants.
Verified March 2014 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Rupert Lanzenberger, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01477203
First received: November 15, 2011
Last updated: March 12, 2014
Last verified: March 2014

November 15, 2011
March 12, 2014
November 2011
July 2015   (final data collection date for primary outcome measure)
  • SSRI induced changes in BOLD (blood oxygen level dependent) response over time [ Time Frame: 4 vears ] [ Designated as safety issue: No ]
  • SSRI induced changes in ERPs (event-related potentials) over time [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • SSRI induced changes in BOLD response over time [ Time Frame: 4 vears ] [ Designated as safety issue: No ]
  • SSRI induced changes in ERPs over time [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    event-related potentials
Complete list of historical versions of study NCT01477203 on ClinicalTrials.gov Archive Site
biochemical data [ Time Frame: 4 years ] [ Designated as safety issue: No ]
these include steroid hormone levels, vitamins, etc.
Same as current
Not Provided
Not Provided
 
Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders
Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders

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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Major Depressive Disorder (MDD)
  • Anxiety Disorder
Drug: Escitalopram
2-4 weeks, 5-10mg, max 20mg
  • Active Comparator: Escitalopram
    50 Major Depressive Disorder Patients and 50 Anxiety Disorder Patients will receive Escitalopram as medication
    Intervention: Drug: Escitalopram
  • No Intervention: Remitted Patients
  • No Intervention: Healthy Controls
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
September 2015
July 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
Yes
Contact: Christoph Kraus, MD 00431404003528 christoph.kraus@meduniwien.ac.at
Austria
 
NCT01477203
FA103FC001, 2011-004860-31
Yes
Rupert Lanzenberger, Medical University of Vienna
Medical University of Vienna
Not Provided
Not Provided
Medical University of Vienna
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP