Trial · NCT07913100
Real-World Impact of TV-44749 in Adults With Schizophrenia
NCT07913100, Not yet recruiting, Teva Branded Pharmaceutical Products R&D LLC
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Real-World Impact of TV-44749 in Adults With Schizophrenia. Trials, record NCT07913100. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07913100
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Real-World Impact of TV-44749 in Adults With Schizophrenia
- NCT number
- NCT07913100
- Status
- Not yet recruiting
- Enrollment
- 1,085 participants, estimated
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D LLC
- Conditions
- Schizophrenia
- Interventions
- TV-44749
- First posted
- 2026-11-03
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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 | Month -12 to Day -1; Day 1 to Month 12 | |
| Secondary | Change in Clinical Global Impression-Severity (CGI-S) Score From Baseline to 6 Months Following Initiation of TV-44749 | Baseline, Month 6 | 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) |
| Secondary | Change in Personal and Social Performance (PSP) Scale Score From Baseline to 6 Months Following Initiation of TV-44749 | Baseline, Month 6 | 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. |
| Secondary | Change in Positive and Negative Syndrome Scale (PANSS-6) Score from Baseline to 6 Months Following Initiation of TV-44749 | Baseline, Month 6 | 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. |
| Secondary | Describe Real-World Utilization of TV-44749 in Adults with Schizophrenia | Baseline, Month 12 | 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) |
| Secondary | To evaluate real-world impact of TV-44749 on healthcare resource utilization (HCRU) and costs, as available | Month -12, Month 12 | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07913100
GET https://conductscience.org/api/trials/v1/NCT07913100/registered