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

NCT05322031 | Completed Phase 4

• 1 other identifier: ARIANNA
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Schizophrenia; Myelin Degeneration; Cognition Disorder

Keywords

Onset of schizophrenia; Aripiprazole long-acting; Myelin; Cognition

Outcome Measures

Primary Outcomes (1)

• Brain structural modifications in terms of myelination of the white matter measured using magnetic resonance imaging

  Evaluation of the modification of the myelination of white matter bundles (in terms of Myelin Water Fraction - MWF) after antipsychotic therapy with aripiprazole long-acting compared to baseline measured using magnetic resonance imaging.

  3 months of therapy

Secondary Outcomes (8)

• Evaluation of efficacy as assessed by Positive and Negative Syndrome scale

  3 months from baseline.

• Evaluation of efficacy as assessed by Brief Psychiatric Rating Scale

  3 months from baseline.

• Changes in cognitive performance through Brief Assessment of Cognition in schizophrenia scale

  3 months from baseline.

• Number of adverse and toxic events due to the administration of aripiprazole

  Through study completion (1 year)

• Evaluation of the statistical correlation between plasma levels of aripiprazole and clinical and structural assestment

  Through study completion (1 year)

Study Arms (1)

Onset of depression

EXPERIMENTAL

15 participants with onset of schizophrenia who, after a period of stabilization with aripiprazole in oral formulation, would begin therapy with long-acting aripiprazole, or already in therapy with long-acting aripiprazole since no more than two weeks.

Drug: Aripiprazole

Interventions

Aripiprazole DRUG

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.

Also known as: Abilify Maintena, Long-acting aripiprazole

Onset of depression

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• presence of codiagnosis with other psychiatric (based on SCID-5 CV) or neurological pathologies;
• 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.

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Prof. Paolo Brambilla

Milan, Italy, 20100, Italy

Location

MeSH Terms

Conditions

Schizophrenia; Cognition Disorders

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Paolo Brambilla, Professor

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  STUDY CHAIR

• Massimo C Mauri, Professor

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: April 11, 2022
• Study Start: August 1, 2022
• Primary Completion: August 31, 2024
• Study Completion: November 30, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)