Clinical Trials from Phase I – IV.
daacro Stresstests

 

 

The Trier Social Stress Test: a pharmacodynamic measure in the development of anxiolytics.

The organism has different systems in order to adapt to mental or physical stress. Especially important in this regards is the attenuation of the hypothalamic-pituitary-adrenal axis and the autonomic nervous system. A lapse of adaptive reaction is a key element for developing anxiety, depression and somatoform disorders.

In this context, the Trier Social Stress Test (TSST) has become a very important protocol reliably provoking psychosocial stress in humans in a laboratory setting. The TSST offers a variety of reliable psychological and biological outcome measures and is therefore predestinated for identifying profiles of anxiolytic or anti-deppressant action of compounds. In development of anxiolytic drugs the TSST can easily be integrated to phase I clinical trials as a pharmacodynamic outcome measure.

Literature:

Fries, Hellhammer & Hellhammmer (2006). Attenuation of hypothalamic-pituitary-adrenal axis responsivity to the Trier Social Stress Test by the benzodiazepine alprazolam. PNEC 31, 1278-1288.

Clinical studies for reliable health claims of food supplements.

Since 2007, all countries in the European Union must follow the high requirements of  EFSA, the European Food Safety Authority  regarding health- related food declaration. 

This is put in order by the Health Claims regulation which is stating that all health-related claims have to be approved explicity, also the ones with positive impacts on mood, relaxation, concentration, memory, intelligence or sleeping behaviour. The health-related impacts of food supplements are often small. Therefore, it is especially important to choose an adequate study population and group size and to apply a measuring method that can reflect the expected impact in a sensivite and reliable manner.

Successful application of the Trier Social Stress Test in studies for skin and hair.

Many of us know it: heavy and chronical stress leaves its mark on skin and hair. In order to identify the mechansims behind and to develop systematic intervention, our stress test can give decisive information.

Double-blind placebo-controlled randomized studies pull together subjects perceived stress and carefully selected biomarkers.

Literature:

Martin, Hellhammer, Hero, Schult, Terstegen (accepted). Effective prevention of stress-induced sweating and axillary malodor formation in teenagers. International Journal for Cosmetic Science.

Clinical studies on stress related health problems

Stress is considered to play a major role in etiology and pathogenesis of several physical and mental disorders.

In Trier, we recently developed neuropattern™, an innovative easy applicable method for the assessment of stress effects of  on health disturbances.

Pharmacokinetics, bioavailability and bioequivalence

The investigation of the pharmacokinetic properties of a new compound is crucial at the beginning of the clinical development. Bioavailability is a pharmacokinetic parameter and records how quickly and to what extent a substance is absorbed and is available at the site of action. Bioequivalence studies are also crucial in this context. In case of generics the aim is to prove that two products are equally absorbed after administration. If the products then have equivalent bioavailability, it is generally considered that they have same clinical effects.

In bioavailability and bioequivalence studies, various key data should be discussed in advance:

  • Design: (1) parallel or nonreplicated/replicated cross-over design and (2) no. of periods
  • Duration of the wash-out phase
  • Sample material: e.g. certain blood, urine or stool tests
  • Duration of the investigation period after ingestion and number of sample collections

Literature:

Bender, C., Candi, I., Rogel, E. (2022).
Bioefficacy of hydroxytyrosol-rich food supplements on preventing lipid peroxidation in healthy men.
bioRxiv 2022.09.21.508834; doi: https://doi.org/10.1101/2022.09.21.508834