anxiety disorder
Conditions
Interventions
Participants receive 1x estketamine (28mg
14mg per 100mL spray) or 1x the
active-comparator (midazolam
1.25mg per dosis).
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Written informed consent • Good physical and mental health as determined by medical screening • Age between 18 and 35 • BMI between 17.5 - 28 • A competent level of English to answer the questionnaires
Exclusion criteria
Exclusion criteria: • Diagnosis of a psychiatric disorder (DSM-V) • Use of any pharmacological treatment at time of inclusion • Current recreational drug use/dependence • Current alcohol dependence • Pregnancy or plans to get pregnant in the near future; • Hypertension (systolic BP >160 mm Hg or diastolic BP >90 mm Hg) • Previous (recreational) use of PCP or ketamine. • Heavy smoking (>10 cigarettes/week) • Having experienced a car accident
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the number and distress of self-reported intrusive memories in the 7 days following the trauma-analogue . This will be analysed using a mixed negative binomial regression. *Participant* and Day (treated as continuous) will be random factors and treatment as fixed factor. | — |
Secondary
| Measure | Time frame |
|---|---|
| Three moderation analyses will be performed to test whether baseline brain derived neurotrophic factor (BDNF) levels, chronic stress and acute stress response moderate the effect of blocking NMDA-receptor on intrusive memories. | — |
Countries
Netherlands
Outcome results
None listed