A Study to Test if TV-46000 is Safe for Maintenance Treatment of Schizophrenia
Public ClinicalTrials.gov record NCT03893825. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Study to Evaluate the Safety, Tolerability, and Effect of Risperidone Extended-Release Injectable Suspension (TV-46000) for Subcutaneous Use as Maintenance Treatment in Adult and Adolescent Patients With Schizophrenia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of the study is to evaluate the long-term safety and tolerability of TV-46000. The primary safety and tolerability endpoint is the frequency of all adverse events, including serious adverse events. For new participants, the total duration of participant participation in the study is planned to be up to 80 weeks (including a screening period of up to 4 weeks, a 12-week oral conversion/stabilization stage \[Stage 1\], a 56-week double-blind maintenance stage \[Stage 2\], and a follow-up period \[8 weeks\]). For roll-over participants, the total duration of participant participation in the study is planned to be up to 64 weeks (including up to 56 weeks in the maintenance stage \[Stage 2\] and a follow-up period \[8 weeks\]). Participants who started Stage 2 who relapse or meet 1 or more of the withdrawal criteria should be invited to perform the Early Termination visit as soon as possible within 4 weeks of the last injection. Participants who withdraw from the study before completing the 56-week maintenance stage will have follow-up procedures and assessments performed at their follow-up visits. During the follow-up period, participants will be treated according to the investigator's judgment. All participants will be treated with active drug.
Study identification
- NCT ID
- NCT03893825
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 336 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 13 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 17, 2019 (Actual)
- Primary completion
- Dec 2, 2021 (Actual)
- Completion
- Dec 2, 2021 (Actual)
- Last update posted
- Dec 7, 2022
2019 – 2021
United States locations
- U.S. sites
- 67
- U.S. states
- 19
- U.S. cities
- 60
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Teva Investigational Site 14391 | Phoenix | Arizona | 85012 | — |
| Teva Investigational Site 14401 | Scottsdale | Arizona | 85258 | — |
| Teva Investigational Site 14405 | Tucson | Arizona | 85719 | — |
| Teva Investigational Site 14796 | Rogers | Arkansas | 72758 | — |
| Teva Investigational Site 14811 | Anaheim | California | 92805 | — |
| Teva Investigational Site 14794 | Bellflower | California | 90706 | — |
| Teva Investigational Site 14776 | Colton | California | 92324 | — |
| Teva Investigational Site 14802 | Costa Mesa | California | 92627 | — |
| Teva Investigational Site 14773 | Culver City | California | 90230 | — |
| Teva Investigational Site 14774 | Glendale | California | 91206 | — |
| Teva Investigational Site 14817 | La Habra | California | 90631 | — |
| Teva Investigational Site 14771 | Lemon Grove | California | 91945 | — |
| Teva Investigational Site 14863 | Long Beach | California | 90807 | — |
| Teva Investigational Site 14816 | Montclair | California | 91763 | — |
| Teva Investigational Site 14786 | Oakland | California | 94607 | — |
| Teva Investigational Site 14827 | Oceanside | California | 92056-4515 | — |
| Teva Investigational Site 14777 | Orange | California | 92868 | — |
| Teva Investigational Site 14815 | Pico Rivera | California | 90660 | — |
| Teva Investigational Site 14785 | San Bernardino | California | 92408 | — |
| Teva Investigational Site 14818 | San Diego | California | 92103 | — |
| Teva Investigational Site 14788 | Torrance | California | 90502 | — |
| Teva Investigational Site 14783 | Coral Gables | Florida | 33134 | — |
| Teva Investigational Site 14865 | Hialeah | Florida | 33012 | — |
| Teva Investigational Site 14787 | Hialeah | Florida | 33016 | — |
| Teva Investigational Site 14814 | Hialeah | Florida | 33018 | — |
| Teva Investigational Site 14861 | Homestead | Florida | 33030 | — |
| Teva Investigational Site 14390 | Lake Mary | Florida | 32746 | — |
| Teva Investigational Site 14799 | Lauderhill | Florida | 33319 | — |
| Teva Investigational Site 14389 | Maitland | Florida | 32751 | — |
| Teva Investigational Site 14875 | Miami | Florida | 33122 | — |
| Teva Investigational Site 14400 | Miami | Florida | 33125 | — |
| Teva Investigational Site 14832 | Miami | Florida | 33126 | — |
| Teva Investigational Site 14810 | North Miami | Florida | 33161 | — |
| Teva Investigational Site 14860 | Tampa | Florida | 33613 | — |
| Teva Investigational Site 14396 | West Miami | Florida | 33144 | — |
| Teva Investigational Site 14821 | Decatur | Georgia | 30030 | — |
| Teva Investigational Site 14770 | Marietta | Georgia | 30060 | — |
| Teva Investigational Site 14415 | Norcross | Georgia | 30093 | — |
| Teva Investigational Site 14829 | Chicago | Illinois | 60640 | — |
| Teva Investigational Site 14805 | Hoffman Estates | Illinois | 60169 | — |
| Teva Investigational Site 14871 | Lincolnwood | Illinois | 60712 | — |
| Teva Investigational Site 14862 | Lake Charles | Louisiana | 70629 | — |
| Teva Investigational Site 14869 | Monroe | Louisiana | 71201 | — |
| Teva Investigational Site 14866 | Gaithersburg | Maryland | 20877 | — |
| Teva Investigational Site 14764 | Glen Burnie | Maryland | 21061 | — |
| Teva Investigational Site 14791 | St Louis | Missouri | 63109 | — |
| Teva Investigational Site 14813 | St Louis | Missouri | 63128 | — |
| Teva Investigational Site 14826 | St Louis | Missouri | 63132 | — |
| Teva Investigational Site 14809 | Las Vegas | Nevada | 89102 | — |
| Teva Investigational Site 14414 | Las Vegas | Nevada | 89109 | — |
| Teva Investigational Site 14792 | Berlin | New Jersey | 08009 | — |
| Teva Investigational Site 14772 | Cedarhurst | New York | 11516 | — |
| Teva Investigational Site 14876 | New York | New York | 10036 | — |
| Teva Investigational Site 14780 | Staten Island | New York | 10312 | — |
| Teva Investigational Site 14867 | Hickory | North Carolina | 28601 | — |
| Teva Investigational Site 14416 | Beachwood | Ohio | 44122 | — |
| Teva Investigational Site 14763 | Cincinnati | Ohio | 45219 | — |
| Teva Investigational Site 14782 | Dayton | Ohio | 45417 | — |
| Teva Investigational Site 14859 | Garfield Heights | Ohio | 44125 | — |
| Teva Investigational Site 14793 | Media | Pennsylvania | 19063 | — |
| Teva Investigational Site 14778 | Charleston | South Carolina | 29407 | — |
| Teva Investigational Site 14868 | Memphis | Tennessee | 38119 | — |
| Teva Investigational Site 14801 | Houston | Texas | 77081 | — |
| Teva Investigational Site 14807 | Irving | Texas | 75062 | — |
| Teva Investigational Site 14393 | Plano | Texas | 75093 | — |
| Teva Investigational Site 14856 | Richardson | Texas | 75080 | — |
| Teva Investigational Site 14395 | Bellevue | Washington | 98007 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03893825, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 7, 2022 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03893825 live on ClinicalTrials.gov.