Lurasidone Non-Interventional Study in Schizophrenia Patients

NCT06527885 | Completed

• 1 other identifier: 153(A)IM21322
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 3

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.

Conditions

Schizophrenia

Keywords

Lurasidone; Patient's treatment satisfaction; Quality of Life; Functioning changes; Schizophrenia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Patient's and caregiver's treatment satisfaction- releif of symptoms

  3 months after treatment

• Patient's functioning & quality of life

  3 months after treatment

• Evaluation of adverse drug reactions, akathisia, other extrapyramidal symptoms by Investigator's Assessment Questionnaire

  3 months after treatment

• Evaluation of the weight gain, signs and symptoms of prolactinby by Investigator's Assessment Questionnaire

  3 months after treatment

• Efficacy evaluation by Clinical global impression

  6 weeks after treatment

Study Arms (1)

Lurasidone Treatment

Adult patients suffering from schizophrenia treated for 3 months with lurasidone according to routine clinical practice.

Drug: Lurasidone

Interventions

Lurasidone DRUG

Patients treated with Lurasidone in according to routine clinical practice, in Italy

Lurasidone Treatment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Concomitant participation in a clinical trial

Sponsors & Collaborators

• Aziende Chimiche Riunite Angelini Francesco S.p.A: lead
• Hippocrates Research: collaborator

Study Sites (3)

ASST degli Spedali Civili di Brescia

Brescia, Italy

Location

Villa Von Siebenthal

Genzano di Roma, 00045, Italy

Location

Azienda Sanitaria Azienda ospedaliero-universitaria Senese

Siena, 53100, Italy

Location

Related Publications (1)

• De Filippis S, Vita A, Cuomo A, Amici E, Giovanetti V, Lombardozzi G, Pardossi S, Altieri L, Cicale A, Dosoli M, Galluzzo A, Invernizzi E, Rodigari P, Mascagni P, Santini C, Falsetto N, Manes MA, Micillo M, Fagiolini A. Treatment satisfaction and effectiveness of Lurasidone on quality of life and functioning in adult patients with schizophrenia in the real-world Italian clinical practice: a prospective 3-month observational study. Ann Gen Psychiatry. 2024 Nov 5;23(1):43. doi: 10.1186/s12991-024-00531-z.

  PMID: 39501351 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 30, 2024
• Study Start: October 21, 2022
• Primary Completion: September 12, 2023
• Study Completion: September 12, 2023
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

IT (3)