NCT02602275

Neuronal Correlates of Neurexan® Action in Mildly to Moderately Stressed Probands

Neuronal Correlates of Neurexan® Action in Mildly to Moderately Stressed Probands - A Randomized, Placebo-controlled, Double-blind, Cross-over Trial of Mode of Action and Response Prediction by Functional Magnetic Resonance Imaging MRI

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Biologische Heilmittel Heel GmbH · Industry
• Sex: Male
• Age: 31 Years – 59 Years
• Healthy volunteers: Accepted

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.

Detailed description

A randomized placebo-controlled, double-blind, two-period crossover study with an explorative design. 40 healthy males aged 31-59 years will be included in the study. Participant allocation to either Neurexan® or Placebo at study start is randomized with a ratio of 1:1, i.e. 20 Neurexan® first to 20 Placebo first individuals. Participants receive totally three tablets of either Neurexan® or Placebo per treatment period orally.

Conditions

• Acute Stress Reaction

Interventions

Type	Name	Description
DRUG	Neurexan	0.6 mg / tablet
DRUG	Placebo	Neurexan-matched Placebo tablet

Timeline

• Start date: 2015-08-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-11-11
• Last updated: 2025-06-24
• Results posted: 2025-05-08

Locations

1 site across 1 country: Germany