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Completed

NCT Number: NCT01477203

Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders

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.

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Key information

Conditions

Major Depressive Disorder (MDD) Anxiety Disorder Anxiety Disorders Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of Vienna, Department for Psychiatrie and Psychotherapie

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Escitalopram

Drug

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

Primary outcomes

  1. SSRI induced changes in BOLD (blood oxygen level dependent) response over time

    Time frame: 4 vears

  2. SSRI induced changes in ERPs (event-related potentials) over time

    Time frame: 4 years

Secondary outcomes

  1. biochemical data

    Time frame: 4 years

    these include steroid hormone levels, vitamins, etc.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Acronym: MAN-BIOPSY

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Nov 22, 2011
Registry last updated
Sep 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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