An observational study in Schizophrenia, sponsored by Teva Branded Pharmaceutical Products R&D LLC. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Teva Branded Pharmaceutical Products R&D LLC (part of Teva Pharmaceutical Industries, Ltd.) · Observational
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.
This study will collect both retrospective and prospective data.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's planned enrollment of 1,085 is above the median of 178 across 506 observational studies indexed under Schizophrenia.
Browse Schizophrenia studies →Teva Branded Pharmaceutical Products R&D LLC is the lead sponsor of 24 studies on the registry; 7 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult participants with a diagnosis of schizophrenia who initiate treatment with TV-44749 according to the approved label.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
subcutaneous injection
Also known as: Olanzapine
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.
Time frame: Month -6 to Day -1; Day 1 to Month 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
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
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)
Time frame: 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.
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
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.
Time frame: Baseline, Month 6
Describe Real-World Utilization of TV-44749 in Adults with Schizophrenia
1. Reason for initiating TV-44749 (ie, reason for discontinuing prior antipsychotic treatment) 2. Patterns of switching to TV-44749, including prior antipsychotic medication and treatment history 3. Proportion of participants with TV-44749 dose adjustments, including direction of adjustment (increase, decrease) 4. Adherence to TV-44749 treatment during the 6- and 12-month periods after the initiation date assessed using the Proportion of Days Covered (PDC). 5. Patterns of concomitant medication use during TV-44749 treatment 6. Reason for discontinuation of TV-44749, if applicable 7. Proportion of participants who discontinue TV-44749 by Months 3, 6, 9, and 12 8. Time to discontinuation of TV-44749 (treatment persistence)
Time frame: Baseline, Month 12
To evaluate real-world impact of TV-44749 on healthcare resource utilization (HCRU) and costs, as available
1. 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. 2. 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.
Time frame: Month -12, Month 12
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Teva Branded Pharmaceutical Products R&D LLC →