Study to Evaluate TV-46000 as Maintenance Treatment in Adult and Adolescent Participants With Schizophrenia
Public ClinicalTrials.gov record NCT03503318. 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 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability 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 purpose of the study is to evaluate the efficacy, safety, and tolerability of different dose regimens of TV-46000 administered subcutaneously (SC) as compared to placebo during maintenance treatment in adult and adolescent participants with schizophrenia. The study will include male and female participants, 13 to 65 years of age, who have a confirmed diagnosis of schizophrenia, are clinically stable, and are eligible for risperidone treatment
Study identification
- NCT ID
- NCT03503318
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 544 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 27, 2018 (Actual)
- Primary completion
- Sep 30, 2020 (Actual)
- Completion
- Dec 3, 2020 (Actual)
- Last update posted
- Mar 10, 2023
2018 – 2020
United States locations
- U.S. sites
- 73
- U.S. states
- 18
- U.S. cities
- 61
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Teva Investigational Site 14769 | Little Rock | Arkansas | 72211 | — |
| 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 14767 | Costa Mesa | California | 92626 | — |
| Teva Investigational Site 14802 | Costa Mesa | California | 92627 | — |
| Teva Investigational Site 14773 | Culver City | California | 90230 | — |
| Teva Investigational Site 14835 | Garden Grove | California | 92845 | — |
| 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 14823 | Long Beach | California | 90822 | — |
| Teva Investigational Site 14816 | Montclair | California | 91763 | — |
| Teva Investigational Site 14803 | Norwalk | California | 90650 | — |
| Teva Investigational Site 14786 | Oakland | California | 94607 | — |
| Teva Investigational Site 14797 | Oceanside | California | 92054 | — |
| 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 14812 | Riverside | California | 92506 | — |
| Teva Investigational Site 14785 | San Bernardino | California | 92408 | — |
| Teva Investigational Site 14818 | San Diego | California | 92103 | — |
| Teva Investigational Site 14828 | San Diego | California | 92103 | — |
| Teva Investigational Site 14819 | San Marcos | California | 92078 | — |
| Teva Investigational Site 14779 | Santa Ana | California | 92705 | — |
| Teva Investigational Site 14788 | Torrance | California | 90502 | — |
| Teva Investigational Site 14768 | Coral Gables | Florida | 33134 | — |
| Teva Investigational Site 14783 | Coral Gables | Florida | 33134 | — |
| Teva Investigational Site 14836 | Hallandale | Florida | 33009 | — |
| Teva Investigational Site 14787 | Hialeah | Florida | 33016 | — |
| Teva Investigational Site 14814 | Hialeah | Florida | 33018 | — |
| Teva Investigational Site 14799 | Lauderhill | Florida | 33319 | — |
| Teva Investigational Site 14832 | Miami | Florida | 33126 | — |
| Teva Investigational Site 14810 | North Miami | Florida | 33161 | — |
| Teva Investigational Site 14831 | Orange City | Florida | 32763 | — |
| Teva Investigational Site 14806 | Orlando | Florida | 32810 | — |
| Teva Investigational Site 14837 | Tampa | Florida | 33614 | — |
| Teva Investigational Site 14824 | Atlanta | Georgia | 30331 | — |
| Teva Investigational Site 14834 | Columbus | Georgia | 31904 | — |
| Teva Investigational Site 14821 | Decatur | Georgia | 30030 | — |
| Teva Investigational Site 14770 | Marietta | Georgia | 30060 | — |
| Teva Investigational Site 14765 | Chicago | Illinois | 60612 | — |
| Teva Investigational Site 14829 | Chicago | Illinois | 60640 | — |
| Teva Investigational Site 14805 | Hoffman Estates | Illinois | 60169 | — |
| Teva Investigational Site 14825 | Shreveport | Louisiana | 71101 | — |
| Teva Investigational Site 14764 | Glen Burnie | Maryland | 21061 | — |
| Teva Investigational Site 14820 | New Bedford | Massachusetts | 02740 | — |
| Teva Investigational Site 14798 | Saginaw | Michigan | 48603 | — |
| 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 14790 | St Louis | Missouri | 63141 | — |
| Teva Investigational Site 14809 | Las Vegas | Nevada | 89102 | — |
| Teva Investigational Site 14792 | Berlin | New Jersey | 08009 | — |
| Teva Investigational Site 14830 | Princeton | New Jersey | 08540 | — |
| Teva Investigational Site 14772 | Cedarhurst | New York | 11516 | — |
| Teva Investigational Site 14804 | New York | New York | 10029 | — |
| Teva Investigational Site 14800 | New York | New York | 10032 | — |
| Teva Investigational Site 14784 | New York | New York | 10036 | — |
| Teva Investigational Site 14780 | Staten Island | New York | 10312 | — |
| Teva Investigational Site 14763 | Cincinnati | Ohio | 45219 | — |
| Teva Investigational Site 14782 | Dayton | Ohio | 45417 | — |
| Teva Investigational Site 14822 | Oklahoma City | Oklahoma | 73112 | — |
| Teva Investigational Site 14789 | Allentown | Pennsylvania | 18104 | — |
| Teva Investigational Site 14833 | Norristown | Pennsylvania | 19403 | — |
| Teva Investigational Site 14775 | Scranton | Pennsylvania | 18503 | — |
| Teva Investigational Site 14793 | Thorndale | Pennsylvania | 19372 | — |
| Teva Investigational Site 14778 | Charleston | South Carolina | 29407 | — |
| Teva Investigational Site 14781 | Dallas | Texas | 75231 | — |
| Teva Investigational Site 14766 | Dallas | Texas | 75243 | — |
| Teva Investigational Site 14801 | Houston | Texas | 77081 | — |
| Teva Investigational Site 14807 | Irving | Texas | 75062 | — |
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 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03503318, 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 Mar 10, 2023 · 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 NCT03503318 live on ClinicalTrials.gov.