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SchizophreniaPhase 3SHINENCT03893825

A Study to Test if TV-46000 is Safe for Maintenance Treatment of Schizophrenia

A Phase 3 study testing TV-46000 in people with Schizophrenia, run by Teva Branded Pharmaceutical Products R&D, Inc. at 90 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 13 to 65 years
Conditions the study is for
Schizophrenia
What is being tested?
TV-46000
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
336 participants
Where
90 sitesin 5 countries
Study dates
17 Apr 2019to 2 Dec 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 13 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Participants Rolling Over from the Pivotal Efficacy Study TV46000-CNS-30072:
  • The participant must have participated in the pivotal efficacy study (Study TV46000-CNS-30072) without experiencing relapse events and without important protocol deviations.
  • If the participant was taking antidepressants or mood stabilizers in Study TV46000-CNS-30072, no dose changes or initiation of treatment with these medications will be permitted.
  • The participant, in the investigator's judgment, requires chronic treatment with an antipsychotic medication.
  • The participant is able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens (oral and SC administration) and non-use of prohibited concomitant medications; can read and understand the written word in order to complete participant-reported outcomes measures; and can be reliably rated on assessment scales.
  • The participant has had a stable place of residence for the previous 3 months before the baseline visit in this study, and changes in residence are not anticipated over the course of study participation.
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  • The participant has no significant life events (such as pending loss of housing, family status change, long travel abroad, surgery, etc) that could affect study outcomes expected throughout the period of study participation.
  • Women of childbearing potential and sexually active female adolescents must agree not to try to become pregnant, and, unless they have exclusively same-sex partners, must agree to use a highly effective method of contraception and agree to continue use of this method beginning 1 month before the first administration of study drug and for the duration of the study and for 120 days after the last injection of study drug.
  • The participant, if adult or adolescent male, is surgically sterile, or, if capable of producing offspring, has exclusively same-sex partners or is currently using an approved method of birth control and agrees to the continued use of this method for the duration of the study (and for 120 days after the last dose of study drug). Male participants with sex partners who are women of childbearing potential must use condoms even if surgically sterile. In addition, male participants may not donate sperm for the duration of the study and for 120 days after taking the study drug.
  • New Participants (Not Rolling Over from the Pivotal Efficacy Study TV46000-CNS-30072):
  • The participant has a diagnosis of schizophrenia
  • The participant has been responsive to an antipsychotic treatment (other than clozapine) in the past year based on investigator judgment (and discussions with family members, caregivers, or healthcare professionals as applicable).
  • The participant, in the investigator's judgment, requires chronic treatment with an antipsychotic medication.
  • The participant is able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens (oral and sc administration) and non-use of prohibited concomitant medications; can read and understand the written word in order to complete participant-reported outcomes measures; and can be reliably rated on assessment scales.
  • The participant has had a stable place of residence for the previous 3 months before screening, and changes in residence are not anticipated over the course of study participation.
  • The participant has no significant life events (such as pending loss of housing, family status change, long travel abroad, surgery, etc) that could affect study outcomes expected throughout the period of study participation.
  • The participant has a body mass index between 18.0 and 38.0 kilograms (kg)/square meter (m^2), inclusive.
  • Women of childbearing potential and sexually active female adolescents must agree not to try to become pregnant, and, unless they have exclusively same-sex partners, must agree to use a highly effective method of contraception and agree to continue use of this method beginning 1 month before the first administration of study drug and for the duration of the study and for 120 days after the last injection of study drug.
  • The participant, if adult or adolescent male, is surgically sterile, or, if capable of producing offspring, has exclusively same-sex partners or is currently using an approved method of birth control and agrees to the continued use of this method for the duration of the study (and for 120 days after the last dose of study drug). Male participants with sex partners who are women of childbearing potential must use condoms even if surgically sterile. In addition, male participants may not donate sperm for the duration of the study and for 120 days after taking the study drug.
  • Additional criteria apply, please contact the investigator for more information.

Who cannot join

  • Participants Rolling Over from the Pivotal Efficacy Study TV46000-CNS-30072:
  • The participant has a finding in the baseline 12-lead electrocardiogram (ECG) that is considered clinically significant in the judgment of the investigator.
  • Poor compliance with study procedures (in the opinion of the investigator or sponsor) during the pivotal efficacy Study TV46000-CNS-30072. This should be discussed on a case-by-case basis.
  • New Participants (Not Rolling Over from the Pivotal Efficacy Study TV46000-CNS-30072) and Roll-Over Participants:
  • The participant is currently on clozapine or has received electroconvulsive therapy in the last 12 months.
  • The participant has a history of epilepsy or seizures, neuroleptic malignant syndrome, tardive dyskinesia, or other medical condition that would expose the participant to undue risk.
Show all 13Show fewer
  • The participant has a positive serology for human immunodeficiency virus (HIV)-1, HIV-2, hepatitis B surface antigen, and/or hepatitis C.
  • The participant has current or a history of known hypersensitivity to risperidone or any of the excipients of TV-46000 or the oral formulation of risperidone used in the stabilization phase.
  • The participant has a substance use disorder, including alcohol and benzodiazepines but excluding nicotine and caffeine.
  • The participant is a pregnant or lactating female.
  • The participant has used an investigational drug other than TV-46000 within 3 months prior to screening or has participated in a non-drug clinical trial within 30 days prior to screening.
  • Vulnerable participants (for example, people kept in detention).
  • Additional criteria apply, please contact the investigator for more information.

Trial locations and contacts

90 sites in 5 countries.

90 sites in 5 countries

United States67 sites

  • Teva Investigational Site 14811

    Anaheim, California, 92805

  • Teva Investigational Site 14416

    Beachwood, Ohio, 44122

  • Teva Investigational Site 14395

    Bellevue, Washington, 98007

  • Teva Investigational Site 14794

    Bellflower, California, 90706

  • Teva Investigational Site 14792

    Berlin, New Jersey, 08009

  • Teva Investigational Site 14772

    Cedarhurst, New York, 11516

  • Teva Investigational Site 14778

    Charleston, South Carolina, 29407

  • Teva Investigational Site 14829

    Chicago, Illinois, 60640

  • Teva Investigational Site 14763

    Cincinnati, Ohio, 45219

  • Teva Investigational Site 14776

    Colton, California, 92324

  • Teva Investigational Site 14783

    Coral Gables, Florida, 33134

  • Teva Investigational Site 14802

    Costa Mesa, California, 92627

  • Teva Investigational Site 14773

    Culver City, California, 90230

  • Teva Investigational Site 14782

    Dayton, Ohio, 45417

  • Teva Investigational Site 14821

    Decatur, Georgia, 30030

  • Teva Investigational Site 14866

    Gaithersburg, Maryland, 20877

  • Teva Investigational Site 14859

    Garfield Heights, Ohio, 44125

  • Teva Investigational Site 14764

    Glen Burnie, Maryland, 21061

  • Teva Investigational Site 14774

    Glendale, California, 91206

  • Teva Investigational Site 14865

    Hialeah, Florida, 33012

  • Teva Investigational Site 14787

    Hialeah, Florida, 33016

  • Teva Investigational Site 14814

    Hialeah, Florida, 33018

  • Teva Investigational Site 14867

    Hickory, North Carolina, 28601

  • Teva Investigational Site 14805

    Hoffman Estates, Illinois, 60169

  • Teva Investigational Site 14861

    Homestead, Florida, 33030

  • Teva Investigational Site 14801

    Houston, Texas, 77081

  • Teva Investigational Site 14807

    Irving, Texas, 75062

  • Teva Investigational Site 14817

    La Habra, California, 90631

  • Teva Investigational Site 14862

    Lake Charles, Louisiana, 70629

  • Teva Investigational Site 14390

    Lake Mary, Florida, 32746

  • Teva Investigational Site 14809

    Las Vegas, Nevada, 89102

  • Teva Investigational Site 14414

    Las Vegas, Nevada, 89109

  • Teva Investigational Site 14799

    Lauderhill, Florida, 33319

  • Teva Investigational Site 14771

    Lemon Grove, California, 91945

  • Teva Investigational Site 14871

    Lincolnwood, Illinois, 60712

  • Teva Investigational Site 14863

    Long Beach, California, 90807

  • Teva Investigational Site 14389

    Maitland, Florida, 32751

  • Teva Investigational Site 14770

    Marietta, Georgia, 30060

  • Teva Investigational Site 14793

    Media, Pennsylvania, 19063

  • Teva Investigational Site 14868

    Memphis, Tennessee, 38119

  • Teva Investigational Site 14875

    Miami, Florida, 33122

  • Teva Investigational Site 14400

    Miami, Florida, 33125

  • Teva Investigational Site 14832

    Miami, Florida, 33126

  • Teva Investigational Site 14869

    Monroe, Louisiana, 71201

  • Teva Investigational Site 14816

    Montclair, California, 91763

  • Teva Investigational Site 14876

    New York, New York, 10036

  • Teva Investigational Site 14415

    Norcross, Georgia, 30093

  • Teva Investigational Site 14810

    North Miami, Florida, 33161

  • 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 14391

    Phoenix, Arizona, 85012

  • Teva Investigational Site 14815

    Pico Rivera, California, 90660

  • Teva Investigational Site 14393

    Plano, Texas, 75093

  • Teva Investigational Site 14856

    Richardson, Texas, 75080

  • Teva Investigational Site 14796

    Rogers, Arkansas, 72758

  • Teva Investigational Site 14785

    San Bernardino, California, 92408

  • Teva Investigational Site 14818

    San Diego, California, 92103

  • Teva Investigational Site 14401

    Scottsdale, Arizona, 85258

  • 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 14780

    Staten Island, New York, 10312

  • Teva Investigational Site 14860

    Tampa, Florida, 33613

  • Teva Investigational Site 14788

    Torrance, California, 90502

  • Teva Investigational Site 14405

    Tucson, Arizona, 85719

  • Teva Investigational Site 14396

    West Miami, Florida, 33144

Other trials in United States

Bulgaria8 sites

  • Teva Investigational Site 59148

    Burgas, 8000

  • Teva Investigational Site 59152

    Kazanlak, 6100

  • Teva Investigational Site 59151

    Lovech, 5500

  • Teva Investigational Site 59149

    Novi Iskar, 1282

  • Teva Investigational Site 59144

    Sofia, 1680

  • Teva Investigational Site 59154

    Varna, 9000

  • Teva Investigational Site 59150

    Varna, 9020

  • Teva Investigational Site 59146

    Vratsa, 3000

Other trials in Bulgaria

Israel6 sites

  • Teva Investigational Site 80162

    Afula, 1834111

  • Teva Investigational Site 80161

    Ashkelon, 7830604

  • Teva Investigational Site 80156

    Haifa, 31096

  • Teva Investigational Site 80155

    Hod HaSharon, 4534708

  • Teva Investigational Site 80157

    Ramat Gan, 5262160

  • Teva Investigational Site 80160

    Tel Aviv, 6423906

Other trials in Israel

Canada5 sites

  • Teva Investigational Site 11171

    Calgary, AL, T2N 4Z6

  • Teva Investigational Site 11170

    Chatham, Ontario, N7L 1C1

  • Teva Investigational Site 11169

    Edmonton, Alberta, T5J 2J7

  • Teva Investigational Site 11174

    Montreal, Quebec, H1N 3M5

  • Teva Investigational Site 11173

    Vancouver, British Columbia, V6Z 2L4

Other trials in Canada

France4 sites

  • Teva Investigational Site 35259

    Clermont-Ferrand, 63003

  • Teva Investigational Site 35257

    Douai, 59500

  • Teva Investigational Site 35260

    Nice, 6002

  • Teva Investigational Site 35256

    Toulon, 83000

Other trials in France

About this study

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

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.

Conditions
Schizophrenia
Being tested
TV-46000, Placebo
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TV-46000Drug

    Also called Risperidone

    TV-46000 will be administered per dose and schedule specified in the arm description.

  • PlaceboDrug

    Placebo matching to TV-46000 will be administered per schedule specified in the arm description.

Study groups in NCT03893825
Study groupRoleWhat they receive
TV-46000 q1mExperimentalParticipants will receive a subcutaneous (SC) injection of TV-46000 at baseline and every 4 weeks (q4w) thereafter for up to 56 weeks. The maximal dose administered to adult participants is comparable to an oral risperidone dose of 5 mg/day, and the maximal dose administered to adolescents is comparable to 4 mg/day.
Receives: Drug: TV-46000
TV-46000 q2mExperimentalParticipants will receive an SC injection of TV-46000 at baseline and every 8 weeks (q8w) thereafter, and a placebo SC injection 4 weeks after baseline and q8w thereafter for up to 56 weeks. The maximal dose administered to adult participants is comparable to an oral risperidone dose of 5 mg/day, and the maximal dose administered to adolescents is comparable to 4 mg/day.
Receives: Drug: TV-46000; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse Events (AEs)

    An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

    Measured: Baseline up to Week 64

  2. Number of Participants With SAEs

    An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. The safety analysis set included all participants who received at least 1 dose of TV46000 in TV-46000-CNS-30072 study or in TV46000-CNS-30078 study.

    Measured: Baseline up to Week 64

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2019
  2. Study start17 Apr 2019
  3. Primary completion2 Dec 2021
  4. Study completion2 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
336 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03893825
Sponsor's protocol ID
TV46000-CNS-30078
Other IDs
2019-000063-24, 2019
Acronym
SHINE
Status last verified
Dec 2022
First submitted
27 Mar 2019
Last updated
7 Dec 2022
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 reviewed for scientific merit, product approval status, and conflicts of interest. 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

Publications

  • Kane JM, Tohami O, Franzenburg KR, Suett M, Sharon N, Merenlender-Wagner A, Eshet R, Harary E, Correll CU. Effects of Long-Term Treatment with TV-46000 on Symptom Improvement Over Time in Stabilized Patients with Schizophrenia. CNS Drugs. 2026 Feb;40(2):247-267. doi: 10.1007/s40263-025-01240-1. Epub 2025 Nov 21.

    PubMed 41272239

  • Correll CU, Knebel H, Harary E, Eshet R, Tohami O, Suett M, Sharon N, Franzenburg KR, Kane JM. Safety Outcomes with the Long-Acting Subcutaneous Antipsychotic TV-46000 in Schizophrenia: A Post Hoc Analysis of Behavioral, Neuromotor, Endocrine, and Cardiometabolic Outcomes from Two Phase 3 Studies. CNS Drugs. 2025 Nov;39(11):1139-1156. doi: 10.1007/s40263-025-01197-1. Epub 2025 Jul 29.

    PubMed 40730715

  • Kane JM, Eshet R, Harary E, Tohami O, Elgart A, Knebel H, Sharon N, Suett M, Franzenburg KR, Davis GL 3rd, Correll CU. A Long-Term Safety and Tolerability Study of TV-46000 for Subcutaneous Use in Patients with Schizophrenia: A Phase 3, Randomized, Double-Blinded Clinical Trial. CNS Drugs. 2024 Aug;38(8):625-636. doi: 10.1007/s40263-024-01102-2. Epub 2024 Jul 2.

    PubMed 38954317

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TV-46000 in people with Schizophrenia, run by Teva Branded Pharmaceutical Products R&D, Inc. at 90 sites in 5 countries.

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 20 inclusion and 13 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: finished, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in United States, Bulgaria, Israel, Canada, France. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (AEs) (time frame: Baseline up to Week 64). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03893825, which also lists 3 linked publications.

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 7 Dec 2022.

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SHINE Clinical Trial NCT03893825 | AzTrials