mildly to moderately stressed probands MedDRA version: 18.0 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: Neurexan®
Product Name: Neurexan®
Pharmaceutical Form: Tablet
CAS Number: 8001000-82-6
Other descriptive name: PASSIFLORA INCARNATA D2
Concentration unit: mg milligram(s)
Concentration typ
Sponsors
Biologische Heilmittel Heel GmbH
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male 2. Age between =31 to =59 years 3. Fluent in German language 4. Nonsmoker 5. Able to understand the explanations and instructions given by the study physician 6. Willing to adhere to the prohibitions and restrictions specified in this protocol 7. Healthy or medically stable on the basis of clinical laboratory tests, physical examination, medical history, vital signs performed at Screening Visit 8. Magnetic Resonance Imaging (MRI) compatible 9. Participants must have signed a written informed consent document prior to any study procedure indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study 10. Trier Inventory for Chronic Stress (TICS) Score = 9 and = 36 11. Perceived Stress Scale (PSS) > 9 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Current or past history of psychotic features or a diagnosis of any psychiatric disorder as defined in the Diagnostic and Statistical Manual of Mental Disorder 4th edition (DSM-IV) Axis I (recurrent major depression, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia and mania) 2. History of depressive episodes during the last 3 months prior to Screening Visit 3. Use of any psychotropic medication or suffering from severe psychiatric illness during the last 3 months prior to Screening Visit 4. Intake of prescription drugs for sleeping disorders or nervousness within one month prior to Screening Visit 5. Intake of over the counter (OTC) medication for the treatment of sleeping disorders or nervousness within the last (one) week prior to Screening Visit 6. High chronic stress as verified with the TICS-SSCS (> 36) 7. Low chronic stress as verified with the TICS-SSCS ( 30 kg/m2 16. Works regularly nights shifts 17. Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic or hematologic disease as defined by clinical screening interview 18. Any somatic disease or other condition the Investigator or their duly assigned representatives believes could affect the ability of the individual to complete the study or the interpretation of the study results 19. Participants with medical illness that may have influenced brain morphology and/or physiology (e.g. uncontrolled hypertension, diabetes) 20. Participants with a history of one or more seizures without a clear and resolved aetiology 21. Participants with claustrophobia 22. Participants with tinnitus 23. Clinically significant acute illness within 7 days prior to randomization 24. Presence of metallic (ferromagnetic) implants (heart pacemaker, aneurysm clips), tattoos or piercings 25. Have received an experimental drug or used an experimental medical device (participation in any other clinical trial) within the last 30 days before study inclusion 26. Participants whose ability to speak for themselves lacks or can be doubted
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: 1. Normalized EEG frontal frequency changes associated with normalized HRV in verum relative to placebo conditions. 2. High morning cortisol and alpha-amylase level predicts increased subjective stress response (VAS, STAI-XI), effect which is reversed in verum but not in placebo condition. 3. Reduced subjects stress perception as assessed with STAI-XI, VAS after MIST task in verum relative to placebo condition. 4. Personality traits assessed with TCI predicted stress response. ;Timepoint(s) of evaluation of this end point: The fMRI and the EEG and the questionnaires will be done on Day 1 and Day 2. Day 1 will take place 7-35 days after the screening visit (=Day 0). Day 2 will take place 7-35 days after Day 1. | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this clinical trial is to explore the effect of Neurexan® on the brain response when participants undergo an emotional stressful condition in verum compared to placebo. The measures testing neuronal responses in the amygdala are assessed from functional MRI during resting state and while participants perform different tasks: an emotional paradigm (Hariri), stress induced task (Montreal Imaging Stress Task - MIST).;Secondary Objective: The secondary objectives are: Explore the effect of Neurexan® on: • association of electroencephalogram (EEG) and heart rate variability (HRV) with amygdala activation and connectivity • morning cortisol as a predictor of subjective (VAS, STAI) and objective stress response in MRI • change in state anxiety and stress perception measured by State-Trait Anxiety Inventory (STAI) and Visual Analogue Scale (VAS) • change in cortisol and amygdala response predicted by individual differences, e.g., personality, childhood traumatic experiences, copying style, self-esteem, somatic symptoms (SCL-90) • change in saliva (cortisol, alpha-amylase) under stress conditions. ;Primary end point(s): Primary endpoints: Brain responses in pre-selected areas 1. Reduced amygdala responsiveness measured by negative face to form contrasts in the Hariri task (Hariri et. al.., 2000: Hariri et. al., 2003) after verum versus placebo condition. 2. Reduced functional connectivity density (FCD) in amygdala after verum versus placebo condition during rest. 3. Reduced whole brain functional connectivity of amygdala after verum versus placebo condition during rest. 4. Reduced local resting state activity of amygdala after verum versus placebo condition. 5. Increased effective connectivity from frontal cortex to amygdala during Hariri experiment after verum versus placebo condition. 6. Reduced stress network activation during stress (MIST) in verum relative to placebo. ;Timepoint(s) of evaluation of this end point: The fMRI a | — |
Countries
Germany
Contacts
Public ContactDr. Istvan Zatik
Biologische Heilmittel Heel GmbH
Outcome results
None listed