Status:
RECRUITING
Time and Virtual Reality in Schizophrenia and Bipolar Disorder
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Schizophrenia
Bipolar Disorder
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Patients with bipolar disorders report an acceleration or slowing of time flow, and patients with schizophrenic spectrum disorders a time fragmentation. These disorders would be linked to disorders of...
Eligibility Criteria
Inclusion
- \- 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
- 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
Key Trial Info
Start Date :
August 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 12 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04432116
Start Date
August 12 2021
End Date
May 12 2027
Last Update
March 5 2025
Active Locations (1)
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1
Services de Psychiatrie I et II - Pôle de Psychiatrie CHRU Strasbourg
Strasbourg, France, 67091