Status:
RECRUITING
The Supplementation Therapy in Autism and Response to Treatment Study
Lead Sponsor:
University of Udine
Conditions:
Autism
Autism Spectrum Disorder
Eligibility:
All Genders
18-35 years
Phase:
NA
Brief Summary
In addition to the "core" symptoms of ASD (i.e., impaired communication, impaired reciprocal social interaction and restricted, repetitive and stereotyped patterns of behaviors or interests), it is es...
Detailed Description
1. RATIONALE FOR CURRENT STUDY The main purpose of the present study is to address a major unmet clinical need for Level 1 autistic individuals with comorbid anxiety and/or depressive symptoms, wi...
Eligibility Criteria
Inclusion
- Individuals diagnosed with Level 1 ASD, as defined using Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5);
- Aged 18-35 years;
- To be able to understand and communicate in Italian;
- To be able to give informed consent.
Exclusion
- Level 2 or Level 3 ASD, as defined using Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) \[47\];
- Current diagnosis of a co-occurring major psychiatric disorder (e.g., major depressive disorder, bipolar affective disorder, psychotic disorders);
- 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);
- 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.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06187090
Start Date
September 1 2023
End Date
November 1 2026
Last Update
January 2 2024
Active Locations (1)
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1
Unit of Psychiatry, University Hospital of Udine
Udine, UD, Italy, 33100