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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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 Intervention Phase
Major Depressive Disorder (MDD)
Anxiety Disorder
Drug: Escitalopram
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • biochemical data [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    these include steroid hormone levels, vitamins, etc.


Estimated Enrollment: 300
Study Start Date: November 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01477203

Contacts
Contact: Christoph Kraus, MD 00431404003528 christoph.kraus@meduniwien.ac.at

Locations
Austria
Medical University of Vienna, Department for Psychiatrie and Psychotherapie Recruiting
Vienna, Austria, 1090
Contact: Christoph Kraus, MD    00431404003528    christoph.kraus@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna
  More Information

Additional Information:
No publications provided

Responsible Party: Rupert Lanzenberger, A/Prof.PD.Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01477203     History of Changes
Other Study ID Numbers: FA103FC001, 2011-004860-31
Study First Received: November 15, 2011
Last Updated: March 12, 2014
Health Authority: Austria: Agency for Health and Food Safety
PharmMed - Medicinal Products and Medical Devices: Austria
AGES - Austrian Agency for Health & Food Safety: Austria

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Anxiety Disorders
Disease
Mental Disorders
Mood Disorders
Behavioral Symptoms
Pathologic Processes
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents

ClinicalTrials.gov processed this record on October 16, 2014