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

Acute Stress Reaction Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Stress Reaction
• Fractures, Stress
• Stress Disorders, Traumatic, Acute

• NCT number: NCT02602275
• Study type: Interventional
• Source: Biologische Heilmittel Heel GmbH
• Status: Completed
• Phase: Phase 2
• Start date: August 2015
• Completion date: December 2015