Explorative Efficacy Profile of Neurexan® in an Experimental Acute Stress Setting in Healthy Subjects (NEUPRO DB)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biologische Heilmittel Heel GmbH
ClinicalTrials.gov Identifier:
NCT01703819
First received: October 8, 2012
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention Phase
Acute Stress Reaction
Drug: Neurexan®
Other: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy Profile of Neurexan® in an Experimental Acute Stress Setting - an Explorative Double-blind Study in Healthy Probands

Resource links provided by NLM:


Further study details as provided by Biologische Heilmittel Heel GmbH:

Primary Outcome Measures:
  • Area under the curve (AUC) of VAS tension values [ Time Frame: -210 minutes to +100 minutes ] [ Designated as safety issue: No ]
  • Area under the curve (AUC) of VAS nervousness values [ Time Frame: -210 minutes to +100 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in tension and nervousness VAS [ Time Frame: -180 minutes, -150 minutes, -120 minutes, -90 minutes, -60 minutes, -30 minutes, -15 minutes, 0 minutes, +15 minutes, +30 minutes, +45 minutes, +60 minutes, +75 minutes, +100 minutes ] [ Designated as safety issue: No ]
  • Changes in saliva cortisol and α-amylase [ Time Frame: -60 minutes, -15 minutes, +15 minutes, +30 minutes, +45 minutes, +60 minutes, +100 minutes ] [ Designated as safety issue: No ]
  • Changes in plasma ACTH, catecholamines, norepinephrine (NE) and epinephrine (E) [ Time Frame: -60 minutes, +15 minutes, +45 minutes, +100 minutes ] [ Designated as safety issue: No ]
  • Changes in Natural Killer (NK) Cells (subgroup) [ Time Frame: -60 minutes, +15 minutes, +45 minutes, +100 minutes ] [ Designated as safety issue: No ]
  • Changes in BP, heart rate and HRV [ Time Frame: -30 minutes, -15 minutes, 0 minutes, +15 minutes, +30 minutes, +45 minutes ] [ Designated as safety issue: No ]
  • State anxiety and stress perception measured by STAI-X1 [ Time Frame: -90 minutes, +15 minutes, +100 minutes ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events [ Time Frame: -180 minutes to +100 minutes ] [ Designated as safety issue: Yes ]

Enrollment: 66
Study Start Date: October 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neurexan®
0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Drug: Neurexan®
Placebo Comparator: Placebo
6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
Other: Placebo

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®.

  Eligibility

Ages Eligible for Study:   31 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01703819

Locations
Germany
Institut fur Medizinische Psychologie und Verhaltensimmunbiologie Universitatsklinikum Essen
Essen, Germany, 45122
Klinische Psychologie und Psychotherapie
Marburg, Germany, 35032
Sponsors and Collaborators
Biologische Heilmittel Heel GmbH
Investigators
Principal Investigator: Manfred Schedlowski, Univ.-Prof Dr Institut für Medizinische Psychologie und Verhaltensimmunbiologie Universitätsklinikum Essen
  More Information

Publications:

Responsible Party: Biologische Heilmittel Heel GmbH
ClinicalTrials.gov Identifier: NCT01703819     History of Changes
Other Study ID Numbers: C1201, 2012-002358-22
Study First Received: October 8, 2012
Last Updated: May 14, 2013
Health Authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
Germany: Gesundheitsamt der Landeshauptstadt Duesseldorf, Zentrales lnspektorat fuer klinische Germany: Pruefstellen in Nordrhein-Westfalen Regierungspraesidium Darmstadt, Dezernat ll 23.1
Germany: Regierungspräsidium Karlsruhe

Keywords provided by Biologische Heilmittel Heel GmbH:
acute stress reaction
stress
stress perception
physiological stress response
Neurexan

Additional relevant MeSH terms:
Fractures, Stress
Stress Disorders, Traumatic, Acute
Fractures, Bone
Wounds and Injuries
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014