Status:
UNKNOWN
Endocannabinoid Activity Remodulation for Psychosis Liability in Youth
Lead Sponsor:
University of Udine
Collaborating Sponsors:
National Research Council (CNR), Institute of Biomolecular Chemistry (ICB), Italy
Conditions:
Clinical High Risk for Psychosis
Ultra High Risk for Psychosis
Eligibility:
All Genders
18-35 years
Phase:
NA
Brief Summary
Clinical High-Risk (CHR) for Psychosis is characterized by the occurrence of unusual stressful experiences (attenuated psychotic symptoms, APS), anxious symptoms, psychological distress, and substanti...
Detailed Description
1. STATE OF THE ART Among clinical high-risk (CHR) for psychosis individuals, 30-35 % will develop a full-blown disorder after 2-2.5 years. To date there are no proper tools to predict whoever will ev...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Individuals diagnosed with CHR-APS, as defined using CAARMS criteria;
- Aged 18-35 years;
- To be able to understand and communicate in Italian;
- To be able to give informed consent.
- Exclusion Criteria
- Lifetime history of a psychotic or manic episode lasting 7 days or longer;
- Active suicidal ideation indicating significant current risk or history of serious suicide attempt in the opinion of the PI, as evaluated at the screening stage;
- Lifetime neurological disorders (e.g., epilepsy, except febrile convulsions) or severe intercurrent physical illness;
- Current treatment with psychotropic medication, with the exception of Selective Serotonin Reuptake Inhibitor (SSRI) stable monotherapy (at least 8 months);
- Lifetime treatment with antipsychotic medication for more than 7 days;
- IQ \< 70;
- Female patients who are pregnant, lactating or not using an acceptable effective form contraception if they are at risk of falling pregnant;
- Taking part in another pharmacological trial.
Exclusion
Key Trial Info
Start Date :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06037993
Start Date
November 1 2022
End Date
November 1 2025
Last Update
September 21 2023
Active Locations (2)
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1
Unit of Psychiatry, University Hospital of Udine
Udine, UD, Italy, 33100
2
Unit of Psychiatry, University Hospital of Udine
Udine, Italy, 33100