Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders

NCT01477203 | Completed Phase 4 DMC

• 2 other identifiers: FA103FC0012011-004860-31
• Study Type: interventional
• Target: 289
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder (MDD); Anxiety Disorder

Outcome Measures

Primary Outcomes (2)

• 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 (1)

• biochemical data

  4 years

Study Arms (3)

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

Escitalopram DRUG

2-4 weeks, 5-10mg, max 20mg

Escitalopram

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• willingness and competence to sign the informed consent form
• 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
• willingness and competence to sign the informed consent form
• willingness and competence to sign the informed consent form
• aged 18-50 years
• drug-free

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna, Department for Psychiatrie and Psychotherapie

Vienna, Vienna, 1090, Austria

Location

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Depressive Disorder, Major; Anxiety Disorders

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A/Prof.PD.Dr.

Study Record Dates

• First Submitted: November 15, 2011
• First Posted: November 22, 2011
• Study Start: November 1, 2011
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 14, 2016

Record last verified: 2016-09

Locations

AU (1)