Clinical trial NCT06527885: Lurasidone Non-Interventional Study in Schizophrenia Patients
Official title: Treatment Satisfaction and Effectiveness of Lurasidone on Quality of Life and Functioning in Adult Patients With Schizophrenia Treated in the Real World Italian Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Lurasidone
Patient's treatment satisfaction
Quality of Life
Functioning changes
Schizophrenia
Lead sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A
Sponsor class: INDUSTRY
Collaborators: name: Hippocrates Research
First posted: 2024-07-30
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from schizophrenia treated with lurasidone, according to routine clinical practice.

Brief summary: The study is a multicentric, national, non-interventional, prospective, single arm study.

The main goal of this study is to gather information about the effects, in a real-life setting, of lurasidone treatment on patient's reported outcomes, in terms of patient's treatment satisfaction, Quality of Life and functioning changes after 6 weeks from lurasidone treatment initiation in schizophrenia patients naïve to lurasidone.

Detailed description: Important aim of the study is to investigate, aspects related to effectiveness, safety and tolerability at 3 months' lurasidone treatment in a routine practice in Italian clinical settings.

Only patients with primary diagnosis of schizophrenia who are prescribed lurasidone was evaluated for inclusion in the study.

Eligibility criteria: Inclusion Criteria:

* Adult (≥18 years) male or female subjects;
* Primary diagnosis of schizophrenia
* Patients not previously treated with lurasidone. The choice to initiate lurasidone treatment is independent of being included in the study;
* Patients legally capable of giving their written consent for participation in the study and for personal data processing.

Exclusion Criteria:

* Concomitant participation in a clinical trial

Primary outcomes:
measure: Patient's and caregiver's treatment satisfaction- releif of symptoms
timeFrame: 6 weeks after treatment
measure: Patient's functioning & quality of life
timeFrame: 6 weeks after treatment
Secondary outcomes:
measure: Patient's and caregiver's treatment satisfaction- releif of symptoms
timeFrame: 3 months after treatment
measure: Patient's functioning & quality of life
timeFrame: 3 months after treatment
measure: Evaluation of adverse drug reactions, akathisia, other extrapyramidal symptoms by Investigator's Assessment Questionnaire
timeFrame: 3 months after treatment
measure: Evaluation of the weight gain, signs and symptoms of prolactinby by Investigator's Assessment Questionnaire
timeFrame: 3 months after treatment
measure: Efficacy evaluation by Clinical global impression
timeFrame: 6 weeks after treatment
measure: Efficacy evaluation by Clinical global impression
timeFrame: 3 months after treatment
measure: Efficacy evaluation by Investigator's Assessment Questionnaire
timeFrame: 6 weeks after treatment
measure: Efficacy evaluation by Investigator's Assessment Questionnaire
timeFrame: 3 months after treament
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: ASST degli Spedali Civili di Brescia
city: Genzano Di Roma
country: Italy
facility: Villa Von Siebenthal
city: Siena
country: Italy
facility: Azienda Sanitaria Azienda ospedaliero-universitaria Senese
Study officials:
References: