SchizophreniaNCT06527885
Lurasidone Non-Interventional Study in Schizophrenia Patients
An observational study of Schizophrenia, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 3 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Lurasidone
- How many people
- 61 participants
- Where
- 3 sitesItaly
- Study dates
- 21 Oct 2022to 12 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from schizophrenia treated with lurasidone, according to routine clinical practice.
Who may be able to join
- 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.
Who cannot join
- Concomitant participation in a clinical trial
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
ASST degli Spedali Civili di Brescia
Brescia
Villa Von Siebenthal
Genzano di Roma, 00045
Azienda Sanitaria Azienda ospedaliero-universitaria Senese
Siena, 53100
About this study
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
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Lurasidone
- Keywords
- Lurasidone, Patient's treatment satisfaction, Quality of Life, Functioning changes, Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LurasidoneDrug
Patients treated with Lurasidone in according to routine clinical practice, in Italy
| Study group | Role | What they receive |
|---|---|---|
| Lurasidone Treatment | Adult patients suffering from schizophrenia treated for 3 months with lurasidone according to routine clinical practice. Receives: Drug: Lurasidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 6 weeks after treatment
Secondary outcomes (8)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months after treament
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start21 Oct 2022
- Primary completion12 Sep 2023
- Study completion12 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hippocrates Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527885
- Sponsor's protocol ID
- 153(A)IM21322
- Status last verified
- Jul 2024
- First submitted
- 26 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39501351
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06527885
- Acronym / sponsor ID
- 153(A)IM21322
- Conditions
- Schizophrenia
- Keywords
- Lurasidone, Patient's treatment satisfaction, Quality of Life, Functioning changes, Schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.AIndustry (pharma, biotech, devices)
- Collaborators
- Hippocrates Research
- Study start
- 21 Oct 2022 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lurasidone Treatment | – | Drug: LurasidoneAdult patients suffering from schizophrenia treated for 3 months with lurasidone according to routine clinical practice. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from schizophrenia treated with lurasidone, according to routine clinical practice.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Concomitant participation in a clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LurasidonePatients treated with Lurasidone in according to routine clinical practice, in Italy | Drug | Lurasidone Treatment |
Primary outcome
Patient's and caregiver's treatment satisfaction- releif of symptoms
Time frame: 6 weeks after treatment
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).
Patient's functioning & quality of life
Time frame: 6 weeks after treatment
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.
8 secondary outcomes
Patient's and caregiver's treatment satisfaction- releif of symptoms
Time frame: 3 months after treatment
Patient's functioning & quality of life
Time frame: 3 months after treatment
Evaluation of adverse drug reactions, akathisia, other extrapyramidal symptoms by Investigator's Assessment Questionnaire
Time frame: 3 months after treatment
Evaluation of the weight gain, signs and symptoms of prolactinby by Investigator's Assessment Questionnaire
Time frame: 3 months after treatment
Efficacy evaluation by Clinical global impression
Time frame: 6 weeks after treatment
Efficacy evaluation by Clinical global impression
Time frame: 3 months after treatment
Efficacy evaluation by Investigator's Assessment Questionnaire
Time frame: 6 weeks after treatment
Efficacy evaluation by Investigator's Assessment Questionnaire
Time frame: 3 months after treament
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Derived from this study: PubMed 39501351De 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's and caregiver's treatment satisfaction- releif of symptoms (time frame: 6 weeks after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06527885, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024; AzTrials last refreshed its copy on 1 Nov 2026.