NCT07057024

Brief Summary

Schizophrenia (SCZ), bipolar disorder (BP), and depression (DEP) are systematically associated with a severe impairment of the overall abilities of patients, which precludes them from functioning adequately in daily life. A large body of literature emphasises the importance of identifying specific markers for these pathologies to prevent or anticipate the emergence of new psychopathological symptoms. As a result, one of the current research challenges is to develop new, faster, and more reliable tools. Eye movements are physiological signs involving brain areas that control cognitive processes. These same processes could be altered in psychiatric disorders, and these alterations could produce many eye movement abnormalities. The literature highlights some eye movement abnormalities specific to each targeted pathology. However, to our knowledge, no study has compared eye movement abnormalities in a virtual environment projected in a head-mounted display (HMD). The investigators hypothesised that an eye tracker connected to an HMD could identify specific eye movement abnormalities of SCZ, BP, and DEP. Recording eye movements specific to these pathologies in pseudo-ecological situations could lead to better identification methods.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
33mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Feb 2026Feb 2029

First Submitted

Initial submission to the registry

December 30, 2024

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 9, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

February 12, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

December 30, 2024

Last Update Submit

March 5, 2026

Conditions

Keywords

virtual realityeye-trackingSchizophreniaBipolar DisorderDepression

Outcome Measures

Primary Outcomes (1)

  • Record dwell time (millisecond) and saccadic parameters (millisecond and degree) using an eye-tracker connected to a virtual reality HMD. Then, compare each measure to identify schizophrenia, bipolar, depression and control group differences.

    Comparison of eye-tracking metrics in schizophrenia, bipolar disorder, depression, and control groups using virtual reality.

    90 minutes

Secondary Outcomes (1)

  • Correlations between clinical and psychometric assessment results and eye-tracking metrics recorded in virtual reality

    95 minutes

Study Arms (1)

Eye movements in virtual reality record

EXPERIMENTAL

All participants will be assessed in virtual reality environments with eye tracking recording environments and eye tracking recording with a Varjo XR4 HMD.

Other: Clinical and eye movements

Interventions

Eye tracking in virtual reality environment: Clinical and psychometric assessment : * Auto-assessment scales : Fagerström Test For Nicotine Dependance (FTND), Annett handedness questionnaire, Alcohol Use Disorders Identification Test (AUDIT), Substance Use Risk Profile Scale (SURPS), Generalized Anxiety Disorder-7 (GAD-7) * Hetero-assessment scales : Young Mania Rating Scale (YMRS), Hamilton Depression Scale (HDRS), Positive And Negative Scale for Schizophrenia (PANSS)

Eye movements in virtual reality record

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • For all participants:
  • Male or female, aged 18 to 60 years
  • Subject having given their written consent to the study For Schizophrenia participants :
  • Diagnosis of schizophrenia according to DSM-V criteria and stabilised for at least three months
  • For bipolar disorder participants :
  • \- Diagnosis of bipolar disorders according to DSM-V criteria and stabilised for at least three months
  • For depressive disorders participants :
  • \- Diagnosis of depressive disorders according to DSM-V criteria and stabilised for at least three months

You may not qualify if:

  • For all the participants :
  • Subjects unable to give consent or not volunteering for the study.
  • Current(s) somatic(s) condition(s)
  • Specific ophthalmological problems (strabismus, amblyopia) incompatible with the devices stereoscopic (VR headsets)
  • Head trauma's history with loss of consciousness
  • Epilepsy history
  • Intellectual disability
  • Difficulties in understanding the French language
  • Current or during the last 6 months of substance abuse or dependence (except tobacco)
  • Freedom restriction by judicial or administrative decision and/or coercive hospitalisation
  • Cybersickness history
  • Pregnancy
  • For healthy control group :
  • Current or previous psychiatric disorder
  • Current psychotropic drug therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Etablissement Public de Santé Barthélemy Durand

Étampes, 91 150, France

Location

Related Publications (9)

  • Carter BT, Luke SG. Best practices in eye tracking research. Int J Psychophysiol. 2020 Sep;155:49-62. doi: 10.1016/j.ijpsycho.2020.05.010. Epub 2020 Jun 3.

    PMID: 32504653BACKGROUND
  • Carvalho N, Laurent E, Noiret N, Chopard G, Haffen E, Bennabi D, Vandel P. Eye Movement in Unipolar and Bipolar Depression: A Systematic Review of the Literature. Front Psychol. 2015 Dec 15;6:1809. doi: 10.3389/fpsyg.2015.01809. eCollection 2015.

    PMID: 26696915BACKGROUND
  • Miskowiak KW, Seeberg I, Kjaerstad HL, Burdick KE, Martinez-Aran A, Del Mar Bonnin C, Bowie CR, Carvalho AF, Gallagher P, Hasler G, Lafer B, Lopez-Jaramillo C, Sumiyoshi T, McIntyre RS, Schaffer A, Porter RJ, Purdon S, Torres IJ, Yatham LN, Young AH, Kessing LV, Van Rheenen TE, Vieta E. Affective cognition in bipolar disorder: A systematic review by the ISBD targeting cognition task force. Bipolar Disord. 2019 Dec;21(8):686-719. doi: 10.1111/bdi.12834. Epub 2019 Oct 16.

    PMID: 31491048BACKGROUND
  • Morita K, Miura K, Kasai K, Hashimoto R. Eye movement characteristics in schizophrenia: A recent update with clinical implications. Neuropsychopharmacol Rep. 2020 Mar;40(1):2-9. doi: 10.1002/npr2.12087. Epub 2019 Nov 27.

    PMID: 31774633BACKGROUND
  • Wiebe A, Kannen K, Selaskowski B, Mehren A, Thone AK, Pramme L, Blumenthal N, Li M, Asche L, Jonas S, Bey K, Schulze M, Steffens M, Pensel MC, Guth M, Rohlfsen F, Ekhlas M, Lugering H, Fileccia H, Pakos J, Lux S, Philipsen A, Braun N. Virtual reality in the diagnostic and therapy for mental disorders: A systematic review. Clin Psychol Rev. 2022 Dec;98:102213. doi: 10.1016/j.cpr.2022.102213. Epub 2022 Oct 30.

    PMID: 36356351BACKGROUND
  • Wolf A, Ueda K, Hirano Y. Recent updates of eye movement abnormalities in patients with schizophrenia: A scoping review. Psychiatry Clin Neurosci. 2021 Mar;75(3):82-100. doi: 10.1111/pcn.13188. Epub 2021 Jan 20.

    PMID: 33314465BACKGROUND
  • Brakemeier S, Sprenger A, Meyhofer I, McDowell JE, Rubin LH, Hill SK, Keshavan MS, Pearlson GD, Tamminga CA, Gershon ES, Keedy SS, Sweeney JA, Clementz BA, Lencer R. Smooth pursuit eye movement deficits as a biomarker for psychotic features in bipolar disorder-Findings from the PARDIP study. Bipolar Disord. 2020 Sep;22(6):602-611. doi: 10.1111/bdi.12865. Epub 2019 Nov 29.

  • Wang Y, Lyu HL, Tian XH, Lang B, Wang XY, St Clair D, Wu R, Zhao J. The similar eye movement dysfunction between major depressive disorder, bipolar depression and bipolar mania. World J Biol Psychiatry. 2022 Nov;23(9):689-702. doi: 10.1080/15622975.2022.2025616. Epub 2022 Feb 3.

  • Zheng Z, Liang L, Luo X, Chen J, Lin M, Wang G, Xue C. Diagnosing and tracking depression based on eye movement in response to virtual reality. Front Psychiatry. 2024 Feb 5;15:1280935. doi: 10.3389/fpsyt.2024.1280935. eCollection 2024.

MeSH Terms

Conditions

Mental DisordersDiseaseSchizophreniaBipolar DisorderDepression

Interventions

Eye Movements

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsSchizophrenia Spectrum and Other Psychotic DisordersBipolar and Related DisordersMood DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

MovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaOcular Physiological Phenomena

Study Officials

  • Eric Artiges

    Etablissement Public de Santé Barthélemy Durand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2024

First Posted

July 9, 2025

Study Start

February 12, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2029

Last Updated

March 6, 2026

Record last verified: 2026-03

Locations