Explorative Efficacy Profile of Neurexan® in an Experimental Acute Stress Setting in Healthy Subjects

NCT ID: NCT01703819

Last Updated: 2015-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-04-30

Brief Summary

The purpose of this study is to evaluate the efficacy of acutely dosed Neurexan using an experimental stress test called the Trier Social Stress Test

Detailed Description

An acute stress reaction is a biopsychological condition arising in response to an event which is individually regarded as emotionally stressful. The onset of a stress response is associated with specific physiological actions in the sympathetic nervous system, both directly and indirectly through the release of adrenaline and to a lesser extent noradrenaline from the medulla of the adrenal glands. These catecholamine hormones facilitate immediate physical reactions by triggering increases in heart rate and breathing, constricting blood vessels. The other major player in the acute stress response is the hypothalamic-pituitary-adrenal axis.

Although stress has been described as a non-specific psychophysiological response to environmental stimuli, it is possible to discern specific bodily stress responses caused by specific emotional reactions to novel, ambivalent or uncontrollable situations and stimuli. For example, social stress induces elevated cortisol levels, particularly if the stressor is uncontrollable, unpredictable, and constitutes a social-evaluative threat due to the judgment of others such as in the Trier Social Stress Test. Usually, the TSST induces a two-fold increase in saliva cortisol with peaks around 10-20 min. after stress test termination. Also, an average increase in heart rates of around 20 beats per minute (bpm) is observed during the TSST. In addition, emotional states and feelings have been shown to be affected by this stress test, such as marked increases in stress perception,anxiety and emotional insecurity as well as decreases in mood, calmness and feeling awake.

Preliminary results indicate that Neurexan® may improve coping abilities in stressful situations. This study aims to investigate the effect of Neurexan® on subjectively perceived nervousness and tension during an acute stressful situation and to characterize the efficacy profile of Neurexan®.

Conditions

Acute Stress Reaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Neurexan®

0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Group Type: EXPERIMENTAL

Neurexan®

Intervention Type: DRUG

0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Placebo

6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Interventions

Neurexan®

0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Intervention Type: DRUG

Placebo

6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes

Intervention Type: OTHER

Other Intervention Names

Lactose monohydrate, magnesium stearate.

Eligibility Criteria

Inclusion Criteria

1. Provide written informed consent

2. Healthy male or female

3. age between 31 to 59 years

4. Fluent in German language.

5. Ability to understand the explanations and instructions given by the study physician

Exclusion Criteria

1. allergies to ingredients of Neurexan® (Passiflora incarnata, Avena sativa, Coffea arabica, Zincum isovalerianicum, lactose monohydrate, magnesium stearate) or Placebo

2. lactose intolerance

3. use of any psychological stress-management intervention within the last 4 weeks

4. sick leave for any reason

5. participation in any other clinical study 3 months prior to Screening Visit

6. current or recent (3 months prior to Screening Visit) history of substance abuse or drug dependence including nicotine and alcohol (as verified in the respective IDCL list)

7. smokers

8. alcohol intake within last 24 hours (before Baseline Visit V3)

9. shift workers or work regularly during night time

10. use of any psychotropic medication or suffering from severe psychiatric illness needing acute intervention

11. BMI > 30 kg/m2

12. currently pregnant (verified by urine pregnancy test) or lactating

13. participation in a previous TSST study

14. high chronic stress as verified with the TICS-SSCS (a score of ≥ 23 on the screening scale for chronic stress meets the criterion of being chronically stressed)

15. major mental disorder as verified with the IDCL (depressive episode, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia and mania.)

16. employee of the Sponsor, one of the investigators or the CRO

17. use of any concomitant medication except contraceptives

18. any somatic disease or other condition the Investigator or their duly assigned representatives believes may affect the ability of the individual to complete the study or the interpretation of the study results

19. Individuals whose ability to speak for themselves lacks or can be doubted

• Minimum Eligible Age: 31 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biologische Heilmittel Heel GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manfred Schedlowski, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut für Medizinische Psychologie und Verhaltensimmunbiologie Universitätsklinikum Essen

Locations

Institut fur Medizinische Psychologie und Verhaltensimmunbiologie Universitatsklinikum Essen

Essen, , Germany

Klinische Psychologie und Psychotherapie, Fachbereich Psychologie, Universität Marburg

Marburg, , Germany

Countries

Germany

References

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Reference Type: BACKGROUND

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Doering BK, Wegner A, Hadamitzky M, Engler H, Rief W, Schedlowski M. Effects of Neurexan (R) in an experimental acute stress setting--An explorative double-blind study in healthy volunteers. Life Sci. 2016 Feb 1;146:139-47. doi: 10.1016/j.lfs.2015.12.058. Epub 2016 Jan 7.

Reference Type: DERIVED

PMID: 26772822 (View on PubMed)

Other Identifiers

2012-002358-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C1201

Identifier Type: -

Identifier Source: org_study_id