We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01477203
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):
Rupert Lanzenberger, 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder (MDD) Anxiety Disorder Drug: Escitalopram Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 289 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders
Study Start Date : November 2011
Primary Completion Date : September 2016
Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Biopsy
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. SSRI induced changes in BOLD (blood oxygen level dependent) response over time [ Time Frame: 4 vears ]
  2. SSRI induced changes in ERPs (event-related potentials) over time [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. biochemical data [ Time Frame: 4 years ]
    these include steroid hormone levels, vitamins, etc.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01477203


Locations
Austria
Medical University of Vienna, Department for Psychiatrie and Psychotherapie
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna

Additional Information:
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 ( EudraCT Number )
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016

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