NCT05322031CompletedPhase 4
The Impact of Aripiprazole Long-acting on Myelin and Cognition in the Onset of Schizophrenia
Source: ClinicalTrials.gov · Last updated 27 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 16 Mar 2022
- Start date
- 1 Aug 2022
- Primary completion date
- 31 Aug 2024
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Diseases
- Schizophrenia
- NCT number
- NCT05322031
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 15
- From 1 Aug 2022 to the primary completion date, 31 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous antipsychotic therapies. Patients previously stabilized with other antipsychotic drugs will still be admitted, provided that they are taken for a period of time not exceeding one month and provided that they have not been taken within 2 weeks prior to enrollment, except for aripiprazole in oral formulation, the intake of which is necessary for the inclusion of aripiprazole in long-acting formulation.
- 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.
Other illness
- presence of codiagnosis with other psychiatric (based on SCID-5 CV) or neurological pathologies;
- history of intellectual disability;
Other
- contraindications to taking aripiprazole long-acting as per SPC;
- abuse of alcohol or substances during the preceding six months;
- presence of absolute or relative contraindications to the execution of MRI;
- underage patients;
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Prof. Paolo Brambilla Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.