Clinical TrialPlaceboPlaceboCompleted

Psyrreal VR Psychedelic Replication Feasibility Study — Estonia 2021

TBD

Target Enrollment
14 participants
Study Type
Phase NA interventional
Design
Non-randomized

Detailed Description

TBD

Study Arms & Interventions

Control VR

placebo

A 5-minute demonstrative VR experience in a small room with a balcony view onto a mountain range, used as a control condition for comparisons with EDI, PIQ, and MEQ30 measures.

Interventions

  • Placebo
    single dose1 doses total

    5-minute demonstrative VR experience

Psyrreal VR

experimental

A 45-minute psychedelic-inspired virtual reality experience implementing various audiovisual and narrative phenomenological elements.

Interventions

  • Placebo
    single dose1 doses total

    45-minute VR experience implemented on the second day of a 2-day intervention

Primary Results(1 publication)

Participants

N = 13Mean age: 33.8 across armsK. et al. 2023

EST-Q2 Depression

Score at Timepoint

Psyrreal VRDay 14·K. et al. 2023

Response Rates

≥50% decrease from baseline in EST-Q2 Depression score

1.8/10(18.0%)·K. et al. 2023

EST-Q2 Depression score <12 (remission)

6/10(60.0%)·K. et al. 2023

Adverse Events (from all publications)

Arm / GroupnAny TEAESevereSeriousDiscont.
Control VRplacebo
Psyrreal VRexperimental134(30.8%)0(0.0%)0(0.0%)0(0.0%)

* Safety data is reported for the entire study population (N=13) across both VR experiences (Control VR and Psyrreal VR) and is not disaggregated by individual VR experience. Therefore, specific counts for the Control VR arm are not available.

* Safety data is reported for the entire study population (N=13) across both VR experiences (Control VR and Psyrreal VR). Four participants (out of 13) mentioned transient nausea. No severe or serious adverse effects were reported, and no discontinuations due to adverse events occurred. This pooled data is assigned to the experimental arm (arm2) as per instructions for pooled data.

Study Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment14 participants
  • Timeline
    Start: 2022-01-01
    End: 2022-01-01
  • Compounds

Locations

Estonia

Related Publications

Your Library

Psyrreal VR Psychedelic Replication Feasibility... — Clinical Trial Details | Blossom