The Impact of Aripiprazole Long-acting on Myelin and Cognition in the Onset of Schizophrenia

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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 neuroprotective that could counteract the progressive neuronal degeneration inherent in the schizophrenic pathology itself.

Each subject will undergo a structured clinical interview to assess the presence/absence of Axis I psychiatric disorders (SCID-5 CV). This evaluation is carried out in common clinical practice as a tool to support diagnosis in patients with suspected schizophrenia.

In all subjects, the cognitive profile will be evaluated through the Brief Assessment of Cognition in schizophrenia (BAC-S). The degree of psychotic symptomatology reported through the administration of specific psychopathological scales such as the Brief Psychiatric Rating Scale (BPRS) and the Positive and Negative Syndrome Scale (PANSS) will also be measured. Further clinical data will be extrapolated from medical records and interviews with psychiatrists, if available.

In patients diagnosed with schizophrenia at the first psychotic episode, the administration of pharmacological therapy with long-acting aripiprazole will take place following the indications of the relevant data sheet.

At the U.O.C. of Neuroradiology of the Fondazione, all enrolled subjects will undergo a 3-Tesla multimodal neuroimaging session that includes:

• T1-weighted sequences: to study the volumetric differences of white and grey matter between subjects before and after treatment;

• Acquisition of myelin sequences: to assess the differences in myelin between subjects before and after treatment;

• DTI sequences: to assess differences in white matter bundles between subjects before and after treatment.

The degree of psychotic symptomatology reported will be evaluated by the repetition of psychopathological scales (BPRS, PANSS). Three months after the start of therapy all patients who have joined the study will carry out a 3T NMR of extra standard care control.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Treatments: Aripiprazole

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.