Lurasidone Non-Interventional Study in Schizophrenia Patients (NIS)

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: 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.

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• Italy
  • Brescia, Italy
    • ASST degli Spedali Civili di Brescia
  • Genzano Di Roma, Italy, 00045
    • Villa Von Siebenthal
  • Siena, Italy, 53100
    • Azienda Sanitaria Azienda ospedaliero-universitaria Senese

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from schizophrenia treated with lurasidone, according to routine clinical practice.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lurasidone Treatment; Adult patients suffering from schizophrenia treated for 3 months with lurasidone according to routine clinical practice.	Drug: Lurasidone; Patients treated with Lurasidone in according to routine clinical practice, in Italy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's and caregiver's treatment satisfaction- releif of symptoms	Patient's and caregiver's satisfaction is evaluated by Seven-point Likert scales derived from Treatment Satisfaction Questionnaire for Medication used to assess patient's and caregiver's satisfaction about efficacy, safety, usability and global impression of medications. Patient's satisfaction with efficacy, safety, ease of use, and overall impression of medication was measured using seven-point Likert scales derived from the Treatment Satisfaction Questionnaire for Medication. Caregiver's satisfaction with efficacy, safety, ease of use, and overall impact on patient management was assessed using seven-point Likert scales derived from the Treatment Satisfaction Questionnaire for Medication. The questionnaire consists of 4 items. Each item is scored on a 7-point Likert scale ranging from 1 (Extremely dissatisfied) to 7 (Extremely satisfied).	6 weeks after treatment
Patient's functioning & quality of life	To assess the Patient's functioning and quality of life a Quality-of-Life Scale was used. Quality Life Scale is a standardized questionnaire that evaluates various aspects of an individual's life, interpersonal relation, instrumental role, Intrapsychic Foundations, Common Objects and Activities and overall satisfaction with life. The Quality of Life Scale is a validated measure of health-related quality of life and functioning in schizophrenia that focuses on intrapsychic, social, and negative symptoms and their impact on functioning in schizophrenia. The questionnaire consists of 21 items in 4 domains: Interpersonal Relations (8 items), Instrumental Role (4 items), Intrapsychic Foundations (7 items), and Common Objects and Activities (2 items). Each item is scored on a 7-point Likert scale ranging from 0 (severe impairment) to 6 (normal or unimpaired functioning). A score is calculated for each domain, and the total score ranges from 0 to 126.	6 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's and caregiver's treatment satisfaction- releif of symptoms	Patient's and caregiver's satisfaction was evaluated by Seven-point Likert scales derived from Treatment Satisfaction Questionnaire for Medication used to assess patient's and caregiver's satisfaction about efficacy, safety, usability and global impression of medications. Patient's satisfaction with efficacy, safety, ease of use, and overall impression of medication was measured using seven-point Likert scales derived from the Treatment Satisfaction Questionnaire for Medication. Caregiver's satisfaction with efficacy, safety, ease of use, and overall impact on patient management was assessed using seven-point Likert scales derived from the Treatment Satisfaction Questionnaire for Medication. The questionnaire consists of 4 items. Each item is scored on a 7-point Likert scale ranging from 1 (Extremely dissatisfied) to 7 (Extremely satisfied).	3 months after treatment
Patient's functioning & quality of life	To assess the Patient's functioning and quality of life a Quality-of-Life Scale was used. Quality Life Scale is a standardized questionnaire that evaluates various aspects of an individual's life, interpersonal relation, instrumental role, Intrapsychic Foundations, Common Objects and Activities and overall satisfaction with life. The Quality of Life Scale is a validated measure of health-related quality of life and functioning in schizophrenia that focuses on intrapsychic, social, and negative symptoms and their impact on functioning in schizophrenia. The questionnaire consists of 21 items in 4 domains: Interpersonal Relations (8 items), Instrumental Role (4 items), Intrapsychic Foundations (7 items), and Common Objects and Activities (2 items). Each item is scored on a 7-point Likert scale ranging from 0 (severe impairment) to 6 (normal or unimpaired functioning). A score is calculated for each domain, and the total score ranges from 0 to 126.	3 months after treatment
Evaluation of adverse drug reactions, akathisia, other extrapyramidal symptoms by Investigator's Assessment Questionnaire	To assess the safety a Investigator's Assessment Questionnaire was used. Investigator's Assessment Questionnaire is a validated, clinician-rated scale, designed to assess relative effectiveness (efficacy, safety, and tolerability) of antipsychotic medications in patients with schizophrenia. The Investigator's Assessment Questionnaire consists of 12 equally weighted items: positive symptoms, negative symptoms, other efficacy symptoms, somnolence, weight gain, signs and symptoms of prolactin elevation, akathisia, other extrapyramidal symptoms, other safety or tolerability issues, cognition, energy, and mood. For each item, the current medication was compared with previous antipsychotic medication on a five-point scale from 1 (much better) to 5 (much worse). Total Investigator's Assessment Questionnaire scores range from 12 to 60 with lower Investigator's Assessment Questionnaire total scores indicating better relative treatment effectiveness.	3 months after treatment
Evaluation of the weight gain, signs and symptoms of prolactinby by Investigator's Assessment Questionnaire	To assess the tolerability a Investigator's Assessment Questionnaire was used. Investigator's Assessment Questionnaire is a validated, clinician-rated scale, designed to assess relative effectiveness (efficacy, safety, and tolerability) of antipsychotic medications in patients with schizophrenia. The Investigator's Assessment Questionnaire consists of 12 equally weighted items: positive symptoms, negative symptoms, other efficacy symptoms, somnolence, weight gain, signs and symptoms of prolactin elevation, akathisia, other extrapyramidal symptoms, other safety or tolerability issues, cognition, energy, and mood. For each item, the current medication was compared with previous antipsychotic medication on a five-point scale from 1 (much better) to 5 (much worse). Total Investigator's Assessment Questionnaire scores range from 12 to 60 with lower Investigator's Assessment Questionnaire total scores indicating better relative treatment effectiveness.	3 months after treatment
Efficacy evaluation by Clinical global impression	To assess the efficacy a Clinical Global Impression - Severity of Illness is used. Clinical Global Impression - Severity of Illness measures the clinician's impression of the patient's current state of mental illness on a 7-point scale ranging from 1 (normal-not at all ill) to 7 (among the most extremely ill patients). Although Clinical Global Impression - Severity is considered a very simple and synthetic tool to assess the severity of schizophrenia it has been demonstrated that it is nonetheless reliable and its indications were consistent with other more sophisticated scales such as Global Assessment of Functioning and Positive and Negative Syndrome Scale . The Clinical Global Impression - Severity requires the knowledge of the patient's clinical history; for this reason, the patient should always be assessed by the same physician in order to detect any change in the patient's condition.	6 weeks after treatment
Efficacy evaluation by Clinical global impression	To assess the efficacy a Clinical Global Impression - Severity of Illness is used. Clinical Global Impression - Severity of Illness measures the clinician's impression of the patient's current state of mental illness on a 7-point scale ranging from 1 (normal-not at all ill) to 7 (among the most extremely ill patients). Although Clinical Global Impression - Severity is considered a very simple and synthetic tool to assess the severity of schizophrenia it has been demonstrated that it is nonetheless reliable and its indications were consistent with other more sophisticated scales such as Global Assessment of Functioning and Positive and Negative Syndrome Scale. The Clinical Global Impression - Severity requires the knowledge of the patient's clinical history; for this reason, the patient should always be assessed by the same physician in order to detect any change in the patient's condition.	3 months after treatment
Efficacy evaluation by Investigator's Assessment Questionnaire	To assess the efficacy a Investigator's Assessment Questionnaire is used. Investigator's Assessment Questionnaire is a validated, clinician-rated scale, designed to assess relative effectiveness (efficacy, safety, and tolerability) of antipsychotic medications in patients with schizophrenia. The Investigator's Assessment Questionnaire consists of 12 equally weighted items: positive symptoms, negative symptoms, other efficacy symptoms, somnolence, weight gain, signs and symptoms of prolactin elevation, akathisia, other extrapyramidal symptoms, other safety or tolerability issues, cognition, energy, and mood. For each item, the current medication was compared with previous antipsychotic medication on a five-point scale from 1 (much better) to 5 (much worse). Total Investigator's Assessment Questionnaire scores range from 12 to 60 with lower Investigator's Assessment Questionnaire total scores indicating better relative treatment effectiveness.	6 weeks after treatment
Efficacy evaluation by Investigator's Assessment Questionnaire	To assess the efficacy a Investigator's Assessment Questionnaire is used. Investigator's Assessment Questionnaire is a validated, clinician-rated scale, designed to assess relative effectiveness (efficacy, safety, and tolerability) of antipsychotic medications in patients with schizophrenia. The Investigator's Assessment Questionnaire consists of 12 equally weighted items: positive symptoms, negative symptoms, other efficacy symptoms, somnolence, weight gain, signs and symptoms of prolactin elevation, akathisia, other extrapyramidal symptoms, other safety or tolerability issues, cognition, energy, and mood. For each item, the current medication was compared with previous antipsychotic medication on a five-point scale from 1 (much better) to 5 (much worse). Total Investigator's Assessment Questionnaire scores range from 12 to 60 with lower Investigator's Assessment Questionnaire scores indicating better relative treatment effectiveness.	3 months after treament

Collaborators and Investigators

• Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A
• Collaborators: Hippocrates Research

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2022
• Primary Completion (Actual): September 12, 2023
• Study Completion (Actual): September 12, 2023

Study Registration Dates

• First Submitted: July 26, 2024
• First Submitted That Met QC Criteria: July 26, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 31, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Schizophrenia; Quality of Life; Lurasidone; Patient's treatment satisfaction; Functioning changes
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Adrenergic alpha-Antagonists; Adrenergic alpha-2 Receptor Antagonists; Lurasidone Hydrochloride
• Other Study ID Numbers: 153(A)IM21322

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No