Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01477203
Other study ID # FA103FC001
Secondary ID 2011-004860-31
Status Completed
Phase Phase 4
First received November 15, 2011
Last updated September 13, 2016
Start date November 2011
Est. completion date September 2016

Study information

Verified date September 2016
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Agency for Health and Food SafetyPharmMed - Medicinal Products and Medical Devices: AustriaAGES - Austrian Agency for Health & Food Safety: Austria
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 289
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

Drug:
Escitalopram
2-4 weeks, 5-10mg, max 20mg

Locations

Country Name City State
Austria Medical University of Vienna, Department for Psychiatrie and Psychotherapie Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary SSRI induced changes in BOLD (blood oxygen level dependent) response over time 4 vears No
Primary SSRI induced changes in ERPs (event-related potentials) over time 4 years No
Secondary biochemical data these include steroid hormone levels, vitamins, etc. 4 years No
See also
  Status Clinical Trial Phase
Recruiting NCT06038721 - Unified Protocol: Community Connections N/A
Not yet recruiting NCT03224845 - Courageous Parents, Courageous Children N/A
Completed NCT02096783 - Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With Gynecologic Cancer N/A
Completed NCT02145429 - Preventing Depression in Late Life: A Model for Low and Middle Income Countries N/A
Completed NCT00794456 - Association of Passiflora Incarnata L; Crataegus Oxyacantha L and Salix Alba L. on Mild and Moderate Anxiety Phase 3
Terminated NCT00896467 - Psychological and Emotional Impact in Patients Undergoing Treatment For Metastatic Cancer Either in a Clinical Trial or as Standard Off-Trial Therapy N/A
Completed NCT00252343 - Efficacy and Safety of SR58611A in Patients With a Generalized Anxiety Disorder Phase 3
Not yet recruiting NCT05867823 - OcupApp: Occupational Self-analysis Intervention Through an Mobile Application N/A
Recruiting NCT04562324 - Efficacy of Electroencephalography (EEG) Neurofeedback (NF) for the Treatment of Anxiety Disorder N/A
Recruiting NCT05989451 - Adaptation of Individual Dialectical Behavior Therapy Intervention for Transdiagnostic Treatment of Emotional Disorders N/A
Not yet recruiting NCT05488418 - Clinical Study of Biomarkers of Stress Resilience: Role of ELK1 and GPR56 N/A
Not yet recruiting NCT03608449 - Doing More With Less": Optimizing Psychotherapeutic Services in the Mental Health System N/A
Completed NCT03400397 - An Effectiveness Study of the Cool Kids Programme N/A
Completed NCT00025844 - Fear Conditioning Using Computer-Generated Virtual Reality N/A
Completed NCT02579928 - Ketamine Infusion for Adolescent Depression and Anxiety Phase 4
Completed NCT02270073 - The Process Outcome Mindfulness Effects in Trainees (PrOMET)-Study N/A
Terminated NCT03764644 - Web-based Attention Bias Modification Treatment for Childhood Anxiety Disorders N/A
Completed NCT01721824 - The Effect of IPS-MA- A Modified Early Supported Employment Intervention for Individuals With Mood or Anxiety Disorders N/A
Completed NCT01425619 - The Effect of Medical Clowns and Topical Anesthetic Cream on Pain and Anxiety in Children Undergoing Allergy Skin Tests N/A
Completed NCT01227980 - Corticotropin-Releasing Hormone Receptor 1 (CRH1) Antagonism in Anxious Alcoholics^ Phase 2

External Links