Clinical TrialAnxiety DisordersPlaceboWithdrawn

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

This randomised controlled parallel group Phase I trial (n=12) evaluated the safety and efficacy of the intervention for specific phobia to spiders.

Target Enrollment
12 participants
Study Type
Phase I interventional
Design
Randomized, triple Blind

Detailed Description

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.

Study Arms & Interventions

Experimental Arm

experimental

Interventions

  • Placebo

Participants

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.

Study Details

  • Status
    Withdrawn
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment12 participants
  • Timeline
    Start: 2018-09-10
    End: 2018-09-19
  • Compound
    Placebo
  • Topic
    Anxiety Disorders

Locations

Unknown facility — Australia

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