Multimodal Assessment of Neurobiological Markers for Psyc... | NCT01477203

Studies
Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders

NCT01477203

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Sep 14, 2016Estimated

Enrollment

289Actual

Phase

Phase 4

Conditions

Major Depressive Disorder (MDD)
Anxiety Disorder

Interventions

Escitalopram

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2011-004860-31	EudraCT Number

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Sep 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Nov 15, 2011

First Submission Date that Met QC Criteria

Nov 18, 2011

First Posted Date

Nov 22, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2016

Last Update Posted Date

Sep 14, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

289Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Escitalopram	Active Comparator	50 Major Depressive Disorder Patients and 50 Anxiety Disorder Patients will receive Escitalopram as medication	Drug: Escitalopram
Remitted Patients	No Intervention
Healthy Controls	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Escitalopram	Drug	2-4 weeks, 5-10mg, max 20mg	Escitalopram

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SSRI induced changes in BOLD (blood oxygen level dependent) response over time		4 vears
SSRI induced changes in ERPs (event-related potentials) over time		4 years

Secondary Outcomes

Measure	Description	Time Frame
biochemical data	these include steroid hormone levels, vitamins, etc.	4 years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Label	URL
Related Info	View source
Related Info	View source

ID	Term
D003865	Depressive Disorder, Major
D001008	Anxiety Disorders

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals
D009570	Nitriles
D001572