NCT05322031

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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 neuroprotective that could counteract the progressive neuronal degeneration inherent in the schizophrenic pathology itself. In other words, the primary objective is to assess if the achievement of therapeutic control of the pathology through the use of antipsychotic drug corresponds to a change in the brain structure, both in terms of morphology and connectivity. A further objective will be to evaluate the effect of long-acting aripiprazole on the clinical outcome (in terms of relapses and clinical symptoms), on the overall functioning and cognitive performance of patients at the first psychotic episode in the context of a diagnosis of schizophrenia. The study will be attended by patients with onset of schizophrenia recruited from the Psychiatric Service of Diagnosis and Care and the Day Hospital of the U.O.C. of Psychiatry of the IRCCS Fondazione Ca' Granda, Ospedale Maggiore Policlinico in Milan. A team of psychologists and medical experts of the UOC of Psychiatry of the Fondazione will conduct the process of enrollment and participation in the study. 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). In patients, 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, upon prescription of the doctor, on the basis of the clinical assessment and independently of participation in the study. The introduction of aripiprazole long-acting drug therapy will follow a period of stabilization with oral aripiprazole, as reported in the data sheet. At the U.O.C. 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. This resonance is an ordinary clinical practice for patients with psychosis. It is important to note that 3T MRI is no longer considered high-field and is now commonly used in the regular clinical practice. For patients, clinical reassessment visits (one per month for 3 months) are already scheduled by practice for the normal management of the clinical situation. 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.

Conditions

• Schizophrenia
• Myelin Degeneration
• Cognition Disorder

Interventions

Type	Name	Description
DRUG	Aripiprazole	Patiens who underwent a a period of stabilization with aripiprazole in oral formulation that begin therapy with long-acting aripiprazole, or already in therapy with long-acting aripiprazole from no more than two weeks.

Timeline

• Start date: 2022-08-01
• Primary completion: 2024-08-31
• Completion: 2024-11-30
• First posted: 2022-04-11
• Last updated: 2024-12-27

Locations

1 site across 1 country: Italy