Neuronal Correlates of Neurexan® Action in Mildly to Moderately Stressed Probands (NCT02602275) | Clinical Trial Compass
CompletedPhase 2
Neuronal Correlates of Neurexan® Action in Mildly to Moderately Stressed Probands
Germany53 participantsStarted 2015-08
Plain-language 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.
Who can participate
Age range
31 Years – 59 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: 1 hour after taking a single dose of Neurexan or placebo
2
Functional Magnetic Resonance Imaging (fMRI) Resting-State Data: Change in Global Functional Connectivity Density of the Amygdala at Rest
Timeframe: 1 hour after taking a single dose of Neurexan or placebo
3
Functional Magnetic Resonance Imaging (fMRI) Resting-State Data: Change in Whole-Brain Functional Connectivity of the Amygdala at Rest
Timeframe: 1 hour after taking a single dose of Neurexan or placebo
4
Functional Magnetic Resonance Imaging (fMRI) Resting-State Data: Baseline Activity of the Amygdala at Rest as Measured by Amplitude of Low-Frequency Fluctuations (ALFF)
Timeframe: 1 hour after taking a single dose of Neurexan or placebo
5
Functional Magnetic Resonance Imaging (fMRI) Task Data: Stress Network Activation in Response to Psychosocial Stress Induction.
Timeframe: 1.5 hours after taking a single dose of Neurexan or placebo
. 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 (\< 9) and PSS ≤ 9
. Participants with Blood Pressure (BP) ≥ 160/100 on day 0 and at randomization