Status:
COMPLETED
The Impact of Aripiprazole Long-acting on Myelin and Cognition in the Onset of Schizophrenia
Lead Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions:
Schizophrenia
Myelin Degeneration
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The general objective of this interventional study is to explore the impact of long-acting arpiprazole on brain structure, in particular potential neurotrophic effects, neurogenetic and neuroprotectiv...
Detailed Description
The general objective of this interventional study is to explore the impact of long-acting arpiprazole on brain structure, in particular potential neurotrophic effects, neurogenetic and neuroprotectiv...
Eligibility Criteria
Inclusion
- onset of schizophrenia diagnosed by the support of structured clinical interview (SCID-5 CV) by specialized medical staff;
- age 18 to 65 years, who, after a period of stabilization with aripiprazole in oral formulation, must start a therapy with long-acting aripiprazole for clinical needs (and therefore regardless of participation in the study) or already in therapy with long-acting aripiprazole not more than two weeks;
- absence of other psychotropic drugs for at least two weeks prior to the start of the study;
- to have signed the informed consent to participate in the study;
- for women of child-bearing age, a pregnancy test (betaHCG urine or blood test) must be carried out immediately before the start of therapy and a highly effective method of contraception must be taken for the duration of the treatment.
Exclusion
- presence of codiagnosis with other psychiatric (based on SCID-5 CV) or neurological pathologies;
- previous antipsychotic therapies. Patients previously stabilized with other antipsychotic drugs will still be admitted, provided that they are taken for a period of time not exceeding one month and provided that they have not been taken within 2 weeks prior to enrollment, except for aripiprazole in oral formulation, the intake of which is necessary for the inclusion of aripiprazole in long-acting formulation.
- contraindications to taking aripiprazole long-acting as per SPC;
- history of intellectual disability;
- abuse of alcohol or substances during the preceding six months;
- presence of absolute or relative contraindications to the execution of MRI;
- underage patients;
- pregnant women (if the pregnancy occurs during the study, the patient will be excluded from the continuation of the study) or women who have not performed a pregnancy test negative result before the start of therapy and who do not adopt valid contraceptive methods.
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05322031
Start Date
August 1 2022
End Date
November 30 2024
Last Update
December 27 2024
Active Locations (1)
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1
Prof. Paolo Brambilla
Milan, Italy, Italy, 20100