Clinical trial NCT01477203: Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders
Official title: Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder (MDD)
Anxiety Disorder
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2011-11-22
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: SSRI induced changes in BOLD (blood oxygen level dependent) response over time
timeFrame: 4 vears
measure: SSRI induced changes in ERPs (event-related potentials) over time
timeFrame: 4 years
Secondary outcomes:
measure: biochemical data
timeFrame: 4 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department for Psychiatrie and Psychotherapie
Study officials:
References: