ACTRN12619001694101TerminatedPhase 4
A randomized placebo controlled trial to investigate the effect of suvorexant on REM sleep and fear extinction recall in healthy volunteers.
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- The University of Melbourne
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Prevention
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (—)
- Sex
- All
Inclusion Criteria
- •1.Aged between 18 – 50 years’ old
- •2.Physically and mentally healthy
- •3.Proficient in English
Exclusion Criteria
- •1.Diagnosis of psychiatric disorder including personality disorder and bipolar disorder and/or total score on PTSD Checklist-5 greater or equal to 30 (Weathers et al., 2013), subscores on Depression, Anxiety Stress Scale 21 greater or equal to 7 (Depression), greater or equal to 6 (Anxiety) and/or greater or equal to 10 (Stress; Henry & Crawford, 2005)
- •2.Physical disorders including severe hepatic or renal impairments, neurological disorders including narcolepsy, epilepsy or seizures and/ or cardiac disorders, including hypotension or hypertension (blood pressure outside 90/60mmHg - 140/90mmHg)
- •3.Sleep disorders and/or sleep disturbances including jetlag or shift work.
- •4.Currently taking any medication that interacts with the study drugs or the central nervous system (e.g. sedatives). Contraceptive pills are ok.
- •5.Regular smokers (social smokers are ok)
- •6.BMI (body mass index) outside of 18.5 – 30kg m2
- •7.Women only: pregnant, breastfeeding and/or trying to get pregnant
Investigators
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