SchizophreniaRADIANCENCT07913100
Real-World Impact of TV-44749 in Adults With Schizophrenia
An observational study of Schizophrenia, run by Teva Branded Pharmaceutical Products R&D LLC.
Trial summary
The main purpose of this trial is to evaluate how TV-44749 (olanzapine long-acting injectable) works in routine clinical practice for adults with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- TV-44749
- Type of treatment
- Injection or infusion
- How many people
- 1,085 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2027to 31 May 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with a diagnosis of schizophrenia who initiate treatment with TV-44749 according to the approved label.
Who may be able to join
- Adult participants 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 participant's study participation
- Availability of at least 6 months of retrospective data prior to treatment initiation
- Written informed consent from the participant or an authorized representative able to provide written informed consent on behalf of the participant
Who cannot join
- 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 human immunodeficiency virus, cancers, liver failure, kidney failure, neuroleptic malignant syndrome, and diabetic ketoacidosis
- The participant has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the participant's ability to participate in this study
- Participation in a clinical trial at the time of enrollment or within previous 6 months
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Real-World Impact of Subcutaneous Long-Acting Injectable Olanzapine Suspension (TV-44749) in Adult Patients With Schizophrenia: RADIANCE Study
The main purpose of this trial is to evaluate how TV-44749 (olanzapine long-acting injectable) works in routine clinical practice for adults with schizophrenia.
Read the detailed description
This study will collect both retrospective and prospective data.
- Conditions
- Schizophrenia
- Being tested
- TV-44749
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TV-44749Drug
Also called Olanzapine
subcutaneous injection
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants with at Least One Psychiatric-Related Hospitalization During the 6-Month Period Post-Initiation of TV-44749 Compared to the 6-Month Period Pre-Initiation of TV-44749
A psychiatric-related exacerbation is defined as worsening psychotic symptoms or functional deterioration attributable to schizophrenia, as documented in routine clinical records. For the primary endpoint, the exacerbation must result in inpatient hospitalization.
Measured: Month -6 to Day -1; Day 1 to Month 6
Secondary outcomes (6)
Proportion of Participants with at Least One Psychiatric-Related Hospitalization During the 12-Month Period Post-Initiation of TV-44749 Compared to the 12-Month Period Pre-Initiation of TV-44749
Measured: Month -12 to Day -1; Day 1 to Month 12
Change in Clinical Global Impression-Severity (CGI-S) Score From Baseline to 6 Months Following Initiation of TV-44749
The CGI-S is a clinician-rated one-item instrument used to assess the participant's current illness severity on a 7-point scale rated from 1 (normal, not ill at all) to 7 (among the most extremely ill patients)
Measured: Baseline, Month 6
Change in Personal and Social Performance (PSP) Scale Score From Baseline to 6 Months Following Initiation of TV-44749
The PSP is a clinician-rated instrument that measures personal and social functioning in participants with schizophrenia and related psychotic disorders. The PSP is a 100-point single-item rating scale, divided into 10 equal intervals, ranging from 1-10 (lack of autonomy in basic functioning) to 91-100 (excellent functioning). The score is based on the assessment of participant's functioning in 4 categories: 1) socially useful activities, including work and study; 2) personal and social relationships; 3) self-care; and 4) disturbing and aggressive behaviors.
Measured: Baseline, Month 6
Change in Positive and Negative Syndrome Scale (PANSS-6) Score from Baseline to 6 Months Following Initiation of TV-44749
The PANSS-6 is a 6-item clinician-rated scale used to assess core symptoms of schizophrenia across 6 items: delusions, conceptual disorganization, hallucinations, blunted affect, social withdrawal, and lack of spontaneity and flow of conversation. Each item is rated on a 7-point scale ranging from 1 (absent) to 7 (extreme), with higher scores indicating greater symptom severity. The total PANSS-6 score ranges from 6 to 42.
Measured: Baseline, Month 6
Describe Real-World Utilization of TV-44749 in Adults with Schizophrenia
- 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 participants 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 participants who discontinue TV-44749 by Months 3, 6, 9, and 12
- Time to discontinuation of TV-44749 (treatment persistence)
Measured: Baseline, Month 12
To evaluate real-world impact of TV-44749 on healthcare resource utilization (HCRU) and costs, as available
- All cause; schizophrenia-related and nonpsychiatric-related HCRU during the 6-and 12-month periods after initiation of TV-44749 will be compared with the corresponding pre-initiation periods.
- All cause; schizophrenia-related and nonpsychiatric-related healthcare and prescription medication cost during the 6- and 12-month periods after initiation of TV-44749 will be compared with the corresponding pre-initiation periods.
Measured: Month -12, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start30 Mar 2027 (estimated)
- Primary completion31 May 2031 (estimated)
- Study completion31 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Teva Branded Pharmaceutical Products R&D LLCThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 1,085 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Study director, Teva Branded Pharmaceutical Products R&D LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913100
- Sponsor's protocol ID
- TV44749-CNS-40299
- Acronym
- RADIANCE
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Impact of Subcutaneous Long-Acting Injectable Olanzapine Suspension (TV-44749) in Adult Patients With Schizophrenia: RADIANCE Study
- ClinicalTrials.gov ID
- NCT07913100
- Acronym / sponsor ID
- RADIANCE / TV44749-CNS-40299
- Conditions
- Schizophrenia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,085 participants (estimated)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2027 (estimated)
- Primary completion
- 31 May 2031 (estimated)
- Study completion
- 31 May 2031 (estimated)
- First posted
- 3 Nov 2026 (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 main purpose of this trial is to evaluate how TV-44749 (olanzapine long-acting injectable) works in routine clinical practice for adults with schizophrenia.
Detailed description
This study will collect both retrospective and prospective data.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with a diagnosis of schizophrenia who initiate treatment with TV-44749 according to the approved label.
Key inclusion criteria (4 listed)
- Adult participants 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 participant's study participation
- Availability of at least 6 months of retrospective data prior to treatment initiation
- Written informed consent from the participant or an authorized representative able to provide written informed consent on behalf of the participant
Key exclusion criteria (5 listed)
- 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 human immunodeficiency virus, cancers, liver failure, kidney failure, neuroleptic malignant syndrome, and diabetic ketoacidosis
- The participant has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the participant's ability to participate in this study
- Participation in a clinical trial at the time of enrollment or within previous 6 months
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 |
|---|---|---|
| TV-44749Also: Olanzapinesubcutaneous injection | Drug | – |
Primary outcome
Proportion of Participants with at Least One Psychiatric-Related Hospitalization During the 6-Month Period Post-Initiation of TV-44749 Compared to the 6-Month Period Pre-Initiation of TV-44749
Time frame: Month -6 to Day -1; Day 1 to Month 6
A psychiatric-related exacerbation is defined as worsening psychotic symptoms or functional deterioration attributable to schizophrenia, as documented in routine clinical records. For the primary endpoint, the exacerbation must result in inpatient hospitalization.
6 secondary outcomes
Proportion of Participants with at Least One Psychiatric-Related Hospitalization During the 12-Month Period Post-Initiation of TV-44749 Compared to the 12-Month Period Pre-Initiation of TV-44749
Time frame: Month -12 to Day -1; Day 1 to Month 12
Change in Clinical Global Impression-Severity (CGI-S) Score From Baseline to 6 Months Following Initiation of TV-44749
Time frame: Baseline, Month 6
Change in Personal and Social Performance (PSP) Scale Score From Baseline to 6 Months Following Initiation of TV-44749
Time frame: Baseline, Month 6
Change in Positive and Negative Syndrome Scale (PANSS-6) Score from Baseline to 6 Months Following Initiation of TV-44749
Time frame: Baseline, Month 6
Describe Real-World Utilization of TV-44749 in Adults with Schizophrenia
Time frame: Baseline, Month 12
To evaluate real-world impact of TV-44749 on healthcare resource utilization (HCRU) and costs, as available
Time frame: Month -12, Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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.
Teva Medical Expert, MD study director
Teva Branded Pharmaceutical Products R&D LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Teva Branded Pharmaceutical Products R&D LLC.
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 5 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: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Teva U.S. Medical Information (1-888-483-8279, USMedInfo@tevapharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants with at Least One Psychiatric-Related Hospitalization During the 6-Month Period Post-Initiation of TV-44749 Compared to the 6-Month Period Pre-Initiation of TV-44749 (time frame: Month -6 to Day -1; Day 1 to Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2026.