Effect of Psychedelic VR-augmented Therapy on Patients With Clinical Depression

NCT ID: NCT06174285

Last Updated: 2025-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-06

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Research has demonstrated that psychedelic compounds possess significant therapeutic potential for a variety of disorders, including depression. Despite these findings, the underlying mechanisms driving the therapeutic efficacy of psychedelics remain elusive. Furthermore, there exists a debate over the contribution of the subjective psychedelic experience to their therapeutic benefits. In this study, virtual reality (VR) is utilized as a tool to replicate the subjective experiences induced by psychedelics, aiming to explore their impact on depressive symptoms within a clinical sample.

The primary objective of this research is to examine the influence of psychedelic-like phenomenology, as simulated through VR, on depressive symptoms. The study is structured into two distinct arms: the experimental condition features 'Psyrreal,' a VR experience designed to emulate psychedelic effects and the control condition which includes 'Routine Realms,' an analogous VR experience devoid of psychedelic elements. A third waiting list condition may be included, dependent on the availability of sufficient participants and resources. Additionally, the study seeks to identify and analyze various potential mediators that might underpin the therapeutic outcomes observed.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Psyrreal

Psychedelic virtual reality experience.

Group Type EXPERIMENTAL

Therapeutic Intervention with Psychedelic Virtual Reality

Intervention Type OTHER

A 55-minute immersive psychedelic virtual reality experience is incorporated into a therapeutic intervention, comprising a preparatory phase and a subsequent integration session based on the individual's experience.

Routine Realms

A non-psychedelic virtual reality experience that is largely analogous to Psyrreal.

Group Type SHAM_COMPARATOR

Therapeutic Intervention with Non-Psychedelic Virtual Reality

Intervention Type OTHER

A 55-minute immersive virtual reality experience is incorporated into a therapeutic intervention, comprising a preparatory phase and a subsequent integration session based on the individual's experience.

No intervention

A conditional waiting list condition. This condition may be included, dependent on the availability of sufficient participants and resources.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Therapeutic Intervention with Psychedelic Virtual Reality

A 55-minute immersive psychedelic virtual reality experience is incorporated into a therapeutic intervention, comprising a preparatory phase and a subsequent integration session based on the individual's experience.

Intervention Type OTHER

Therapeutic Intervention with Non-Psychedelic Virtual Reality

A 55-minute immersive virtual reality experience is incorporated into a therapeutic intervention, comprising a preparatory phase and a subsequent integration session based on the individual's experience.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Persistent depressive symptoms observed during the initial screening and confirmed at baseline, as determined through a comprehensive psychiatric evaluation.
* Provision of written informed consent by the participant.
* Fluent in Estonian as a native language.

Exclusion Criteria

* Presence of significant impairments in vision, hearing, or balance.
* Active suicidal ideation or current engagement in self-harm behaviors. Note: Individuals meeting this criterion will be directed to suitable crisis intervention services.
* Established diagnosis of bipolar disorder.
* Manifestation of psychotic symptoms.
* History of schizophrenia, either personally or within two generations of the family lineage.
* Ongoing diagnosis of epilepsy, dementia, or any other neurological condition that could interfere with the effective utilization of virtual reality (VR) technology.
* Susceptibility to motion sickness.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Confido Medical Centre

UNKNOWN

Sponsor Role collaborator

University of Tartu

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Karl Kristjan Kaup

Junior Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jaan Aru, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Tartu

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Confido Medical Centre

Tallinn, Harju, Estonia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Estonia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Karl Kristjan Kaup, MSc

Role: CONTACT

+372 5342 8489

Kadi Tulver, PhD

Role: CONTACT

+372 522 9245

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Helen Kadastik, Dr

Role: primary

+372 528 6278

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DB-RCT-PSYRREAL

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

bWell-D Pilot Randomized Controlled Trial
NCT06546917 NOT_YET_RECRUITING NA