Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders (MAN-BIOPSY)
This study is currently recruiting participants.
Verified November 2011 by Medical University of Vienna
Sponsor:
Medical University of Vienna
Information provided by (Responsible Party):
Rupert Lanzenberger, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01477203
First received: November 15, 2011
Last updated: November 22, 2011
Last verified: November 2011
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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
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: | November 22, 2011 |
| 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:
|
Anxiety Disorders Mental Disorders Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Behavioral Symptoms 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 Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Serotonin Agents |
ClinicalTrials.gov processed this record on May 19, 2013