Time and Virtual Reality in Schizophrenia and Bipolar Disorder (VirtualTimes)
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ClinicalTrials.gov Identifier: NCT04432116 |
Recruitment Status :
Not yet recruiting
First Posted : June 16, 2020
Last Update Posted : June 16, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Schizophrenia Bipolar Disorder | Behavioral: virtual reality 1 Behavioral: virtual reality 2 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Non-Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | All interventions are applied to each participant |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | EEG and Behavioural Correlates of Virtual Reality Treatment of Environmental Zeitgebers in Schizophrenia and Bipolar Disorder |
Estimated Study Start Date : | September 2020 |
Estimated Primary Completion Date : | December 2023 |
Estimated Study Completion Date : | December 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: virtual reality 1
the subject is in a virtual room and is asked to emit a retrospective time duration judgement at the end of the session
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Behavioral: virtual reality 1
the subject is in a virtual waiting room, there is no other intervention. The principle of this intervention is to make the subject wait with as little interfering events as possible |
Experimental: virtual reality 2
the subject is in a virtual environment mimicking a space ship. The subject is asked to detect targets as fast as possible while the background of the virtual environment is a starfield with standard speed vs. self-determined speed vs. static stars
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Behavioral: virtual reality 2
Subjects are in a virtual environment mimicking a space ship. On the screen there is a red light and subjects wait for this red light to become green. They press on a pad each time the red light becomes green
Other Name: virtual reality 3 |
Experimental: virtual reality 3
the subject is in a virtual environment mimicking a space ship. The subject is asked to detect targets as fast as possible.Asynchronous distracters vs. synchronous distracters, vs no distracters are displayed while the subjects wait for the target
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Behavioral: virtual reality 2
Subjects are in a virtual environment mimicking a space ship. On the screen there is a red light and subjects wait for this red light to become green. They press on a pad each time the red light becomes green
Other Name: virtual reality 3 |
- EEG index of time expectation [ Time Frame: through study completion, an average of 2 years ]beta oscillations recorded with EEG during the waiting period
- retrospective duration [ Time Frame: through study completion, an average of 2 years ]Retrospective duration judgement

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- - Participant, male or female, between 18 and 60 years old
- Subject affiliated to a social health insurance scheme (beneficiary or entitled person)
- Subject who has dated and signed an informed consent form
- For a woman of childbearing age, negative pregnancy test and effective contraception throughout the study
- A patient under guardianship, whose guardian has dated and signed a consent, as well as the patient if able.
- A patient under guardianship, whose consent has been obtained, if necessary, by the guardian or with the assistance of the guardian, prior to the commencement of any trial-related procedures.
Patients only:
- Patients with psychotic disorders (schizophrenia-like): Patients with diagnostic criteria for schizophrenia as defined by the DSM V (American Psychiatric Association, 2015).
- Patients with Bipolar Disorder: A patient with diagnostic criteria for bipolar disorder as defined by the DSM V (American Psychiatric Association, 2015).
Exclusion Criteria:
- Substance Use Disorders (as defined by DSM-V)
- Intake of benzodiazepines (in the period before inclusion, for a duration equivalent to 5 half-lives of the product), cannabis (in the 2 months before inclusion) or hallucinogenic substances (in the period before inclusion, for a duration equivalent to 5 half-lives of the product).
- A neurological pathology or sequelae
- Attention Deficit Hyperactivity Disorder (ADHD)
- Borderline personality disorder
- Disabling sensory impairment, including visual acuity (corrected, if applicable) < 0.8 (due to the use of visual aids) (Freiburg Vision Test, Bach 1996)
- Person deprived of liberty or under the safeguard of justice
- Pregnant, parturient or breastfeeding women
- Subject in a period of exclusion defined by another clinical study.
Healthy volunteers only:
History of major neurological or psychiatric illness with ongoing psychotropic medication (i.e., antidepressant, thyroid regulator, antipsychotic, benzodiazepine or hypnotic).
Patients only:
Only patients treated with neuroleptics, whether or not combined with an anti-parkinsonian corrector or anti-depressant, will be included. Patients taking benzodiazepines will be excluded
Responsible Party: | Institut National de la Santé Et de la Recherche Médicale, France |
ClinicalTrials.gov Identifier: | NCT04432116 |
Other Study ID Numbers: |
C19-48 |
First Posted: | June 16, 2020 Key Record Dates |
Last Update Posted: | June 16, 2020 |
Last Verified: | May 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Schizophrenia Bipolar Disorder Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Bipolar and Related Disorders |