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

Phase 1

Withdrawn

• Conditions: Specific phobia to spiders; Mental Health - Other mental health disorders

• Registration Number: ACTRN12618001381279
• Lead Sponsor: Douglas Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-16
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: Interventional
• Study Design: Not specified