Phase 2
N=66
Explorative Efficacy Profile of Neurexan® in an Experimental Acute Stress Setting in Healthy Subjects
Acute Stress Reaction
Bottom Line
View on ClinicalTrials.gov: NCT01703819 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: Acute Stress Measured by Tension — 3335.7; 3360.3 mm*min — p=0.7726
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Neurexan® (Drug); Placebo (Other)
- Age
- Adult · 31+ yrs
- Sex
- All
- Sponsor
- Biologische Heilmittel Heel GmbH
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acute Stress Measured by Tension |
3335.7; 3360.3 | 0.7726 |
| PRIMARY Acute Stress Measured by Nervousness |
3147.4; 3022.5 | 0.5702 |
| SECONDARY Changes in Saliva Alpha Amylase |
112.9; 133.3; 201.9; 216.0; 140.8; 142.1 | — |
| SECONDARY Changes in Saliva Cortisol |
7.1; 7.1; 19.4; 20.0; 15.3; 21.2 | — |
| SECONDARY Changes in Plasma Adrenocorticotropic Hormone (ACTH) |
22.5; 19.1; 37.7; 37.0; 20.3; 20.7 | — |
| SECONDARY Changes in Plasma Cortisol |
331.6; 325.5; 441.1; 569.8; 403.1; 535.4 | — |
| SECONDARY Changes in Plasma Catecholamines (Epinephrine) |
42.6; 35.6; 32.9; 47.4; 41.4; 26.4 | — |
| SECONDARY Changes in Plasma Catecholamines (Norepinephrine) |
463.0; 457.0; 584.0; 591.5; 481.0; 476.0 | — |
| SECONDARY Changes in Natural Killer (NK) Cells (Subgroup) |
13.5; 11.65; 21.00; 20.40; 10.30; 9.10 | — |
| SECONDARY Changes in Blood Pressure |
122.0; 123.5; 132.0; 142.0; 125.0; 133.5 | — |
| SECONDARY Changes in Heart Rate |
70.0; 69.0; 88.0; 89.5; 69.5; 71.0 | — |
| SECONDARY State Anxiety and Stress Perception Measured by STAI-X1 |
31.0; 29.5; 54.5; 51.5; 33.0; 31.5 | — |
| SECONDARY Psychological Questionnaire (Modified Somatic SCL90) |
0.000; 0.000; 0.000; 0.000 | — |
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
Eligibility Criteria
Inclusion Criteria
- Provide written informed consent
- Healthy male or female
- age between 31 to 59 years
- Fluent in German language.
- Ability to understand the explanations and instructions given by the study physician
Exclusion Criteria
- allergies to ingredients of Neurexan® (Passiflora incarnata, Avena sativa, Coffea arabica, Zincum isovalerianicum, lactose monohydrate, magnesium stearate) or Placebo
- lactose intolerance
- use of any psychological stress-management intervention within the last 4 weeks
- sick leave for any reason
- participation in any other clinical study 3 months prior to Screening Visit
- 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)
- smokers
- alcohol intake within last 24 hours (before Baseline Visit V3)
- shift workers or work regularly during night time
- use of any psychotropic medication or suffering from severe psychiatric illness needing acute intervention
- BMI > 30 kg/m2
- currently pregnant (verified by urine pregnancy test) or lactating
- participation in a previous TSST study
- 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)
- major mental disorder as verified with the IDCL (depressive episode, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia and mania.)
- employee of the Sponsor, one of the investigators or the CRO
- use of any concomitant medication except contraceptives
- 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
- Individuals whose ability to speak for themselves lacks or can be doubted
Data sourced from ClinicalTrials.gov (NCT01703819). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.