About RADIANCE
Study Design
The RADIANCE Study consists of a retrospective pre-initiation period and a prospective observation period.
- Retrospective information from up to 12 months prior to TV-44749 initiation will be documented based on routine clinical records.
- Prospective data will be collected during routine clinical visits for up to 12 months after the initiation date.*
*Participants will also be asked to complete voluntary questionnaires in countries where such data collection is permitted.
Inclusion Criteria
- Adult patients with a diagnosis of schizophrenia, as per clinical judgement
- Newly prescribed or has initiated treatment with TV-44749 within the past 30 days, in accordance with the approved local label, and decided prior to and independently of patient’s study participation
- Availability of at least 6 months of retrospective data prior to treatment initiation
- Written informed consent from the patient or an authorized representative able to provide written informed consent on behalf of the patient
Exclusion Criteria
- Established diagnosis of treatment-resistant schizophrenia, including current treatment with clozapine, clozapine treatment within the past 3 months, or treatment-resistant schizophrenia in the opinion of the investigator, as documented in the medical record
- Prior non-response to TV-44749 per clinician’s judgement
- Established current diagnosis of HIV, cancers, liver failure, kidney failure, neuroleptic malignant syndrome, and diabetic ketoacidosis
- The patient has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the patient’s ability to participate in this study
- Participation in a clinical trial at the time of enrollment or within previous 6 months
Primary Endpoint
Proportion of patients with at least one psychiatric-related hospitalization during the 6-month post-initiation period compared with the proportion during the 6-month pre-initiation period
Secondary Endpoints
Proportion of patients with at least one psychiatric-related hospitalization during the 12-month post-initiation period compared with the proportion during the 12-month pre-initiation period
Change in CGI-S score from baseline to 6 months following initiation of TV-44749
Change in PSP score from baseline to 6 months following initiation of TV-44749
Change in PANSS-6 score from baseline to 6 months following initiation of TV-44749
- Reason for initiating TV-44749 (ie, reason for discontinuing prior antipsychotic treatment)
- Patterns of switching to TV-44749, including prior antipsychotic medication and treatment history
- Proportion of patients with TV-44749 dose adjustments, including direction of adjustment (increase, decrease)
- Adherence to TV-44749 treatment during the 6- and 12-month periods after the initiation date assessed using the Proportion of Days Covered (PDC)
- Patterns of concomitant medication use during TV-44749 treatment
- Reason for discontinuation of TV-44749, if applicable
- Proportion of patients who discontinue TV-44749 by Months 3, 6, 9, and 12
- Time to discontinuation of TV-44749 (treatment persistence)
The following will be assessed during the 6- and 12-month periods after initiation of TV-44749 and compared with the corresponding pre-initiation period:
- All-cause; schizophrenia-related and nonpsychiatric-related HCRU
- All-cause; schizophrenia-related and nonpsychiatric-related healthcare and prescription medication cost
See Official Trial Listings for additional details.
Abbreviations: CGI-S, Clinical Global Impression-Severity; HCRU, healthcare resource utilization; HIV, human immunodeficiency virus; PANSS-6, Positive and Negative Syndrome Scale-6 Item Version; PSP, Personal and Social Performance.
Time Investment
For Patients
- All treatment decisions, including initiation, dosing, continuation, or discontinuation of TV-44749 and any concomitant therapies, will be made independently of study participation and solely at the discretion of the treating clinician.
- Patients are anticipated to have approximately monthly routine clinical encounters based on TV-44749 dosing frequency.
- No protocol-mandated interventions or visits will be imposed, and patient management will remain consistent with local standards of care.
- Visit timing and frequency will be determined by routine clinical practice; therefore, missed or delayed visits or procedures are not considered protocol deviations and do not require specific documentation.
- PROs may be completed by the patient independently and will be collected only where permitted by local regulations and ethics approvals. PROs will be completed electronically using a web-based platform dedicated to the study, where feasible.
- HCRU (except psychiatric-related hospitalizations and ED visits) and cost data are not collected by study sites and will be obtained exclusively through optional linkage to routinely collected healthcare data from external sources, where permitted by local regulations and with patient consent.
Actual visit schedules and procedures may vary by study site.
For Investigators
- Data for this study will be obtained from documentation generated during routine clinical care and managed within a validated, 21 CFR Part 11-compliant clinical data management system, as applicable to the data source.
- Retrospective data required for the primary endpoint will be collected from available medical records at study entry, and prospective data will be entered as information becomes available during the follow-up period.
- All designated site personnel will receive study specific and system training prior to performing data entry.
- Clinician-reported outcome measures will be completed electronically using a web-based platform dedicated to the study, where feasible.
- All data collected by the site will be approved by the investigator at the investigational site. This approval acknowledges the investigator’s review and acceptance of the data as being complete and accurate.
Abbreviations: ED, emergency department; HCRU, healthcare resource utilization; PRO, patient-reported outcome.