Can the double orexin receptor antagonist suvorexant increase rapid eye movement (REM) sleep and improve sleep-dependent processing of emotional memories in healthy adults?

Phase 4

Terminated

Conditions: PTSD
Mental Health - Other mental health disorders

Registration Number: ACTRN12619001694101

Lead Sponsor: The University of Melbourne

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Stopped early

Sex: All

Target Recruitment: 30

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amount of REM sleep visually scored from the PSG output.[ 1. Test night (night after drug intake)<br>2. Home sleep recording (2nd night after drug intake)<br>];Fear extinction recall measured via SCR[ Follow up (about 48h after drug intake).]

Secondary Outcome Measures

Name	Time	Method
Group differences on fear conditioning measured via SCR.[ Test day];Number and description of intrusive memories (assessed from the open-ended question of the intrusive memory diary).[ Every day during the week after the follow up.];Group differences on fear extinction learning measured via SCR.[ Test day];Rating of vividness of intrusive memories (0=not at all, 10=extremely).[ Every day during the week after the follow up];Rating of distress of intrusive memories (0=not at all, 10=extremely).[ Every day during the week after the follow up.]