Clinical TrialDepressive DisordersEnrolling by invitation

Using Virtual Reality to Control the Audio-visual Inputs During Ketamine/Esketamine Treatment

This interventional trial (n=10) will explore the impact of audiovisual stimuli using virtual reality on the tolerability and effectiveness of ketamine/esketamine treatment for depressive episodes.

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

Detailed Description

Single-group study of virtual reality gear and content provided during a single ketamine/esketamine treatment session in patients on maintenance treatment for depression to assess tolerability and treatment effectiveness.

Outcomes include measures of tolerability, patient-reported experience, and depressive symptom change following the treatment session.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Treatment group

experimental

Single-group intervention: all participants receive virtual reality gear during a ketamine/esketamine treatment session.

Interventions

  • Compound
    via Other• single session

    Virtual reality gear and content used to control audiovisual perception during a single ketamine/esketamine treatment.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Participants must be at least 18 years old
  • Patients must have completed the acute series of treatment and weekly optimization phases of ketamine/esketamine treatment, and currently receiving continuation/maintenance treatment
  • Written consent for the study procedures
  • Ability and willingness, in the investigator's judgement, to comply with the study procedure and study requirements.

Exclusion Criteria

  • Exclusion Criteria:
  • Hearing or visual impairment to the degree that would interfere with ability to see or hear VR content.
  • Difficulty in understanding spoken or written English
  • Unable to provide informed consent
  • Dementia or other cognitive disorder or intellectual disability that would impair the subject's ability to understand the study procedure (per investigator judgment)
  • Any other medical or psychiatric comorbidity that the investigator judges would put the participant at additional undue risk due to study participation or would impair subject's ability to participate in the study.
  • Was previously enrolled/randomized into the study

Study Details

  • Status
    Enrolling by invitation
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment10 participants
  • Timeline
    Start: 2024-02-01
    End: 2024-10-31
  • Topic
    Depressive Disorders

Locations

Yale Psychiatry Hospital Interventional Psychiatry Services (IPS) unit — New Haven, Connecticut, United States

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