A single centre, double blind, randomised, parallel group, single dose signal study of R-107 in participants with DSM-5 specific phobia

A single centre, double blind, randomised, parallel group, single dose signal study of R-107 in particpants with DSM-5 specific phobia, to spiders.

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618001381279

Enrollment

Registered

2018-08-16

Start date

2018-09-10

Completion date

2018-09-19

Last updated

2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a single centre, double blind, randomised, parallel group, single-dose signal study of R-107 in participants with DSM-5 specific phobia to spiders. 12 participants will be randomised to receive a single dose of either R-107 or placebo. The hypothesis is that compared with placebo, R-107 will reduce anxiety self-ratings and avoidance behaviour associated with exposure to a phobic object (spider) in participants known to have a specific phobia according to DSM-5 criteria. Participants will complete several assesments prior to receiveing the dose, and then again 3 hours and 72 hours later.

Interventions

Participants will be administered a single dose of 120mg R-107 or matching placebo tablets. The dose will consist of 2 identical tablets, each tablet contains 60mg of R-107 (or placebo). Participants will be closely observed at the time of dosing and a mouth check will take place immediately after swallowing. Participants will take 240ml water with the dose. Tablets are to be swallowed whole, both at the same time. Participants will be dosed individually so each participant is closely obse

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 40 Years

Healthy volunteers

Inclusion criteria

Able to provide informed consent; able and willing to comply with study requirements including clinic visits; male or female (not pregnant or lactating); aged 18-40 years; BMI 18-35kg/m2; diagnosed with DSM-5 specific phobia to spiders for at least 12 months; able to swallow tablets; score >95 on Fear of Spiders questionnaire (at screening visit)

Exclusion criteria

Clinically significant medical history or medications; clinically significant illness in last 30 days or febrile illness in last 5 days prior to Day 1; history of schizophrenia or other psychotic illness; currently taking benzodiazepines; prior exposure to ketamine; history of drug or alcohol abuse or dependency, including ketamine or it's excipients; clinically significant abnormal ECG or laboratory test result during screening; pregnant or breastfeeding female, or not using effective contraception; involvement in another clinical drug or device trial or less than 60 days since last participation; not having a GP or do not consent to GP being contacted; not able to understand information provided about the study, or not able to be compliant with required procedures; malignancy in last 5 years; employee/family member of sponsor, or study site.

Outcome results