Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders (MAN-BIOPSY)
Primary Purpose
Major Depressive Disorder (MDD), Anxiety Disorder
Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Escitalopram
Sponsored by
About this trial
This is an interventional diagnostic trial for Major Depressive Disorder (MDD)
Eligibility 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
Sites / Locations
- Medical University of Vienna, Department for Psychiatrie and Psychotherapie
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
No Intervention
No Intervention
Arm Label
Escitalopram
Remitted Patients
Healthy Controls
Arm Description
50 Major Depressive Disorder Patients and 50 Anxiety Disorder Patients will receive Escitalopram as medication
Outcomes
Primary Outcome Measures
SSRI induced changes in BOLD (blood oxygen level dependent) response over time
SSRI induced changes in ERPs (event-related potentials) over time
Secondary Outcome Measures
biochemical data
these include steroid hormone levels, vitamins, etc.
Full Information
NCT ID
NCT01477203
First Posted
November 15, 2011
Last Updated
September 13, 2016
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT01477203
Brief Title
Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders
Acronym
MAN-BIOPSY
Official Title
Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder (MDD), Anxiety Disorder
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
289 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Escitalopram
Arm Type
Active Comparator
Arm Description
50 Major Depressive Disorder Patients and 50 Anxiety Disorder Patients will receive Escitalopram as medication
Arm Title
Remitted Patients
Arm Type
No Intervention
Arm Title
Healthy Controls
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Intervention Description
2-4 weeks, 5-10mg, max 20mg
Primary Outcome Measure Information:
Title
SSRI induced changes in BOLD (blood oxygen level dependent) response over time
Time Frame
4 vears
Title
SSRI induced changes in ERPs (event-related potentials) over time
Time Frame
4 years
Secondary Outcome Measure Information:
Title
biochemical data
Description
these include steroid hormone levels, vitamins, etc.
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Medical University of Vienna, Department for Psychiatrie and Psychotherapie
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Links:
URL
http://www.meduniwien.ac.at/neuroimaging/
Description
Related Info
URL
http://biol-psy.univie.ac.at/
Description
Related Info
Learn more about this trial
Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders
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