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 range31 Years – 59 Years

SexMALE

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
✕. 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

What they're measuring

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

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

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

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

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

Trial details

NCT IDNCT02602275

SponsorBiologische Heilmittel Heel GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-12

Results submitted2023-03-28

View on ClinicalTrials.gov More Acute Stress Reaction trials

Who can participate

Age range31 Years – 59 Years

SexMALE

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
✕. 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