Conditions: Acute Stress Reaction
Keywords: Stress, amygdala, functional MRI, Hariri paradigm, TSST
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 53
Healthy volunteers: yes

Brief 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.

Arms:
arm 1: Participants received a single dose of three Neurexan tablets on trial Day 1. Following a washout period of 7 to 35 days, they received a single dose of three placebo tablets on trial Day 2. arm 2: Participants received a single dose of three Placebo tablets on trial Day 1. Following a washout period of 7 to 35 days, they received a single dose of three Neurexan tablets on trial Day 2.

Interventions: intervention 1: Neurexan intervention 2: Placebo
Intervention descriptions: intervention 1: 0.6 mg / tablet intervention 2: Neurexan-matched Placebo tablet

Protocol document: