Effect of antipsychotic therapy with aripiprazole long-acting on the brain structure of patients with a first episode of schizophrenia

The impact of aripiprazole long-acting on myelin and cognition in the onset of schizophrenia - ARIANNA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-004404-18-IT

Enrollment

Registered

2021-10-20

Start date

2021-12-15

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Onset of schizophrenia MedDRA version: 20.0 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders

Interventions

Trade Name: ABILIFY MAINTENA - 300 MG - POLVERE E SOLVENTE PER SOSPENSIONE A RILASCIO PROLUNGATO PER INIEZIONE - USO INTRAMUSCOLARE - FLACONCINO (VETRO) - POLVERE: 300 MG + SOLVENTE: 2 ML - 1 FLACONCI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with onset of schizophrenia, diagnosed using a structured clinical interview (SCID- 5 CV) by medical doctors. - Patients between 18 and 65 years of age, who, after a stabilization period with aripiprazole in oral formulation, have to start aripiprazole long-acting therapy for clinical reasons (i.e. regardless of study participation) or who have been on therapy for no more than two weeks. - No other psychotropic treatments in the two weeks before entering the study - Ability to provide informed consent - Fertile women can only be included after a negative highly sensitive urine or serum pregnancy test (betaHCG). Women must use a highly effective birth control method for the entire duration of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 14 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1

Exclusion criteria

Exclusion criteria: - Comorbidity with other psychiatric disorders (on the basis of SCID 5- CV) or neurologic disorders; - Previous antipsychotic treatments. However, patients previously stabilised with other antipsychotic drugs will be admitted, provided that they have not been treated for more than one month and in the two weeks prior to enrolment. Only administration of aripiprazole in oral formulation, necessary for the insertion of long acting aripiprazole, is allowed. - Contraindications to taking long-acting aripiprazole as described in SmPC; - Medical history of intellectual disability; - Alcohol or substances abuse in the last 6 months; - Presence of absolute or relative contraindications to the performance of MRI; - Pregnant women (if pregnancy occurs during the study, the patient will be excluded from continuing the study) or women of childbearing age who have not carried out a negative pregnancy test before taking the drug and who are not using a highly effective method of contraception.

Design outcomes

Primary

Measure	Time frame
Main Objective: The overall objective is to explore the impact of long acting aripiprazole on brain structure, in particular the potential neurotrophic, neurogenetic and neuroprotective effects that could counteract the progressive neuronal degeneration inherent in psychotic pathology itself. In other words, the primary objective is to assess whether the achievement of therapeutic control of the pathology by this antipsychotic drug corresponds to a change in brain structure, in terms of connectivity.;Secondary Objective: - Evaluate the impact of long-acting aripiprazole on clinical outcome (in terms of number of relapses and symptomatology), global functioning and cognitive performances in patients at first episode of psychosis - evaluate the safety profile of the drug - investigate the change in brain structure, in terms of morphology associated to the use of long-acting aripiprazole;Primary end point(s): Changes in Myelination of specific white tracts (Myelin Water Fraction- MWF) after 3 months of antipsychotic treatment with long-acting aripiprazole compared to the basal.;Timepoint(s) of evaluation of this end point: Three months	—

Measure

Time frame

Main Objective: The overall objective is to explore the impact of long acting aripiprazole on brain structure, in particular the potential neurotrophic, neurogenetic and neuroprotective effects that could counteract the progressive neuronal degeneration inherent in psychotic pathology itself. In other words, the primary objective is to assess whether the achievement of therapeutic control of the pathology by this antipsychotic drug corresponds to a change in brain structure, in terms of connectivity.;Secondary Objective: - Evaluate the impact of long-acting aripiprazole on clinical outcome (in terms of number of relapses and symptomatology), global functioning and cognitive performances in patients at first episode of psychosis - evaluate the safety profile of the drug - investigate the change in brain structure, in terms of morphology associated to the use of long-acting aripiprazole;Primary end point(s): Changes in Myelination of specific white tracts (Myelin Water Fraction- MWF) after 3 months of antipsychotic treatment with long-acting aripiprazole compared to the basal.;Timepoint(s) of evaluation of this end point: Three months

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Secondary

Measure	Time frame
Secondary end point(s): - Evaluation of the efficacy of aripiprazole on clinical outcome, measured by changes in the score of the psychopathological scales (PANSS and BPRS), and on cognitive performance, measured in terms of changes in the scores of the neuropsychological scales (BAC-S), at 3 months compared to baseline; - Number of serious and non-serious AEs related to the treatment with long-acting aripiprazole. Adverse events will be assessed on the basis of the patient's clinical observation, laboratory tests (e.g. biochemical, haematological, urine tests) or other clinical tests (e.g. ECG, radiological tests, vital signs) - Brain structure modifications (gray matter volumes, cortical area and thickness) after 3-month treatment with long-acting aripiprazole compared to the basal;;Timepoint(s) of evaluation of this end point: Three months	—

Measure

Time frame

Secondary end point(s): - Evaluation of the efficacy of aripiprazole on clinical outcome, measured by changes in the score of the psychopathological scales (PANSS and BPRS), and on cognitive performance, measured in terms of changes in the scores of the neuropsychological scales (BAC-S), at 3 months compared to baseline; - Number of serious and non-serious AEs related to the treatment with long-acting aripiprazole. Adverse events will be assessed on the basis of the patient's clinical observation, laboratory tests (e.g. biochemical, haematological, urine tests) or other clinical tests (e.g. ECG, radiological tests, vital signs) - Brain structure modifications (gray matter volumes, cortical area and thickness) after 3-month treatment with long-acting aripiprazole compared to the basal;;Timepoint(s) of evaluation of this end point: Three months

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Countries

Italy

Contacts

Public ContactUOC Psichiatria

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

paolo.brambilla@policlinico.mi.it0255035952

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026