Phase 2
N=40
Neuronal Correlates of Neurexan® Action in Mildly to Moderately Stressed Probands
Acute Stress Reaction
Bottom Line
View on ClinicalTrials.gov: NCT02602275 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Functional Magnetic Resonance Imaging (fMRI) Task Data: BOLD Activation Changes Within Amygdala During Negative Faces in the Hariri Face Matching Task Between Placebo and Neurexan Treatment — 0.196; 0.361 Beta value — p=0.004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Neurexan (Drug); Placebo (Drug)
- Age
- Adult · 31+ yrs
- Sex
- Male
- Sponsor
- Biologische Heilmittel Heel GmbH
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Magnetic Resonance Imaging (fMRI) Task Data: BOLD Activation Changes Within Amygdala During Negative Faces in the Hariri Face Matching Task Between Placebo and Neurexan Treatment |
0.196; 0.361 | 0.004 sig |
| PRIMARY Functional Magnetic Resonance Imaging (fMRI) Resting-State Data: Change in Global Functional Connectivity Density of the Amygdala at Rest |
0.0139; -0.0073 | >0.05 |
| PRIMARY Functional Magnetic Resonance Imaging (fMRI) Resting-State Data: Change in Whole-Brain Functional Connectivity of the Amygdala at Rest |
-0.0127; 0.0239 | <0.001 sig |
| PRIMARY Functional Magnetic Resonance Imaging (fMRI) Resting-State Data: Baseline Activity of the Amygdala at Rest as Measured by Amplitude of Low-Frequency Fluctuations (ALFF) |
-0.0120; 0.0007 | >0.05 |
| PRIMARY Functional Magnetic Resonance Imaging (fMRI) Task Data: Stress Network Activation in Response to Psychosocial Stress Induction. |
0.02; 0.41 | <0.05 sig |
Summary
The purpose of this study is to explore the effect of Neurexan® on the brain response when participants undergo an emotional stressful condition in verum compared to placebo.
Eligibility Criteria
Inclusion Criteria
- Male
- Age between ≥31 to ≤59 years
- Fluent in German language
- Nonsmoker
- Able to understand the explanations and instructions given by the study physician
- Willing to adhere to the prohibitions and restrictions specified in this protocol
- Healthy on the basis of clinical laboratory tests, physical examination, medical history, vital signs performed at Screening Visit
- Magnetic Resonance Imaging (MRI) compatible
- 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
- Screening Scale for Chronic Stress of the Trier Inventory for Chronic Stress (TICS-SSCS) Score ≥ 9 and ≤ 36
- Perceived Stress Scale (PSS) > 9
Exclusion Criteria
- 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)
- History of depressive episodes during the last 3 months prior to Screening Visit
- Use of any psychotropic medication or suffering from severe psychiatric illness during the last 3 months prior to Screening Visit
- Intake of prescription drugs for sleeping disorders or nervousness within one month prior to Screening Visit
- Intake of over the counter (OTC) medication for the treatment of sleeping disorders or nervousness within the last (one) week prior to Screening Visit
- High chronic stress as verified with the TICS-SSCS (> 36)
- Low chronic stress as verified with the TICS-SSCS ( 30 kg/m2
- Works regularly nights shifts
- Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic or hematologic disease as defined by clinical screening interview
- 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
- Participants with medical illness that may have influenced brain morphology and/or physiology (e.g. uncontrolled hypertension, diabetes)
- Participants with a history of one or more seizures without a clear and resolved aetiology
- Participants with claustrophobia
- Participants with tinnitus
- Clinically significant acute illness within 7 days prior to randomization
- Presence of metallic (ferromagnetic) implants (heart pacemaker, aneurysm clips), tattoos or piercings
- 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
- Participants whose ability to speak for themselves lacks or can be doubted
Data sourced from ClinicalTrials.gov (NCT02602275). 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.