Metformin Treatment on Cognitive Impairment of Schizophrenia
NCT05838573
Cognition Disorders, Cognitive Dysfunction
Changsha, Hunan, China
View Trial DetailsNCT Number: NCT03130478
This is an observational, retrospective, non-interventional study that will include schizophrenic patients who were initiated on AOM treatment during an schizophrenia-related hospitalisation at least 6 months before data collection and in a real clinical practice setting.
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Notify Me18 year and older
All sexes
Observational
Hospital Universitario de Álava, Alava, Spain
This is an observational, retrospective, non-interventional study that will include schizophrenic patients who were initiated on AOM treatment during an schizophrenia-related hospitalisation at least 6 months before data collection and in a real clinical practice setting.
Data from each patient will be collected after informed consent is obtained (if possible), and will include retrospective information mainly from the index date (start of AOM treatment, baseline timepoint) until the last information available in the patient file at the time of data collection (minimum of 6 months after the index date). Data will be retrospectively collected from all visits occurring as per clinical practice (usually once-monthly).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
If allowable by Ethics Committees, provision of oral (e.g., by phone) instead of written consent is also possible for patients with retrospective assessment only.
Exclusion criteria
Time frame: First 6 months after treatment initiation
To describe in real-world practice the impact of demographic and clinical characteristics on persistence in patients with schizophrenia initiated on aripiprazole once-monthly (AOM) during an inpatient stay due to an acute schizophrenia relapse.
Time frame: From treatment initiation up to patient inclusion (minimum 6 months)
Date of AOM interruption or discontinuation and reason for discontinuation
Time frame: From treatment initiation up to patient inclusion (minimum 6 months)
Clinical Global Impressions - Severity (CGI-S) scale at index date (if available in patient's file or estimated by the investigator according to medical records) and CGI-S up to patient's inclusion (if available in patients' file or estimated by the investigator according to medical records). CGI-S up to patient's inclusion (if available in patients' file or estimated by the investigator according to medical records).
Time frame: From treatment initiation up to patient inclusion (minimum 6 months)
Brief Psychiatric Rating Scale (BPRS) at index date (if available in patient's file) and BPRS up to the patient's inclusion (if available in patients' file).
Time frame: From treatment initiation up to patient inclusion (minimum 6 months)
Description of AOM treatment (starting dose and dose adjustments, number of injections, prior and concomitant medications, settings)
Time frame: From treatment initiation up to patient inclusion (minimum 6 months)
Description of health resource use (HRU) related to schizophrenia (hospitalisations, medications, non-pharmacological therapies, outpatient visits, procedures)
Time frame: From treatment initiation up to patient inclusion (minimum 6 months)
Description of non-pharmacological interventions aiming to improve functionality (including, if applicable, initiation and end dates of Institutional support, Cognitive behavioural therapy (CBT), Assertive Community Treatment/Case management, Group or individual psychoeducation, Family psychoeducation, Group or individual psychotherapy, Structured rehabilitation program, Occupational support, Severe mental illness management program)
Time frame: From treatment initiation up to patient inclusion (minimum 6 months)
To qualitatively describe patterns of drug abuse and/or dependence
Otsuka Pharmaceutical Europe Ltd
Industry
Predictors of Persistence in Patients With Schizophrenia Treated With Once-monthly Aripiprazole Long-acting Injection in the Spanish Clinical Practice: a Retrospective, Observational Study
Acronym: PROSIGO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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