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

NCT05322031 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-12-27

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    lead OTHER

Principal Investigators

  • Paolo Brambilla, Professor · Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  • Massimo C Mauri, Professor · Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2024-08-31
Completion
2024-11-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05322031 on ClinicalTrials.gov