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:
Participant gender:
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
Details
Lead Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico