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Country of origin: Germany

Summary

A small German company performing phase I and IV clinical trials for pharmaceutical companies, clinical studies for healthcare and food supplements industry has developed new tools for the assessment of stress and stress related disorders in humans. The tools produce high reproducible data about the impact of psychotropic compounds or allow to personalizing individual treatments. The company is ready to be a partner in European research projects, e.g. current ERA-Net call 'NEURON'

Full description

Performing phase I and IV clinical trials for pharmaceutical companies and clinical studies for healthcare and food supplements industries the company has developed a new pharmacodynamic test that serves as a tool for assessing the impact of psychotropic compounds on anxiety, depressions and stress in humans.

1) The Trier Social Stress Test (TSST)
As the first Clinical Research Organisation (CRO) they demonstrated the high sensitivity of the “Trier Social Stress Test” to the effects of anxiolytic compounds. It has been shown that psychobiological reaction profiles can be influenced by nutraceuticals, functional food or psychotropic drugs. The test is based on the changing of these reaction patterns in response to consumed compounds or applied therapeutics.
Depending on the compound and the target, different measuring instruments are available to be added to the study protocol that is performed in nine different Modules:

Module I – Autonomic Response Measures
Module II - Endocrinological Response Measures
Module III – Immunological Response Measures
Module IV – Hematological Response Measures
Module V – Metabolic Response Measures
Module VI – Gene Expression
Module VII – Psychomotor Response Measures
Module VIII – Psychological Response Measures
Module IX – Pain threshold

Although the TSST is today considered the “gold standard” in human stress research, the protocol is rather rigid. Thus, they introduce an extended modulary protocol, the “tsst+”, which allows to specifically adapt this test to given research demands.

The different standardized modules now allow to separately assess treatment effects on the following variables:

(a) Psychological stress by self-assessment and panel-assessment at relevant time points;
(b) psychomotor responses by voice analyses and limb movements;
(c) autonomic responses by skin conductance, heart rate, blood pressure, and levels of epinephrine and orepinephrine;
(d) endocrine and metabolic responses;
(e) immune responses;
(f) oxidative stress responses
(g) pain sensitivity


2) The NeuropatternTM:
Chronic stress can provoke numerous dysfunctions of brain and the body. A new diagnostic system based on the most recent neurobiological research has been developed to improve treatment of stress related health disorders. This psychobiological diagnostic tool can easily be applied in in- and outpatients screening for discrete endophenotypes, related to stress related disorders, such as anxiety, depression, somatoform and adjustment disorders. The tool serves to discriminate subgroups of patients, and allows personalized treatments.

Partner expertise sought:

The ideal partner should be a healthcare, pharmaceutical, food and cosmetic industry and clinical/medical research organisations, public and private research organisations.

Partners should be active in pharmaceutical research and development, developme

Listed under: Medicine and Health

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Key dates Profile created on: 08 February 2010 Date last updated: 23 February 2010 Closing date: 31 December 2010

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