Back to results

Study to Evaluate TV-46000 as Maintenance Treatment in Adult and Adolescent Participants With Schizophrenia (RISE)

Primary Purpose

Schizophrenia

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

TV-46000

Placebo

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

13 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The participant has a diagnosis of schizophrenia for >1 year and has had ≥1 episode of relapse in the last 24 months.
The participant has been responsive to an antipsychotic treatment (other than clozapine) in the past year based on discussions with family members or healthcare professionals.
The participant has 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 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 drugs 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, or 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
- Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

The participant has a current clinically significant Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, or amnestic or other cognitive disorders, or borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
The participant is currently on clozapine or 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.
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 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 has previously participated in a Teva-sponsored clinical study with TV-46000.
The participant is a pregnant or lactating female.
The participant has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).
The participant has used an investigational drug within 3 months prior to screening or has participated in a non-drug clinical trial within 30 days prior to screening.
- Additional criteria apply, please contact the investigator for more information

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

TV-46000 q1m

TV-46000 q2m

Arm Description

Participants will receive an SC injection of placebo matching to TV-46000 at baseline and every 4 weeks (q4w) thereafter. Participants will continue treatment until they experience a relapse event; meet 1 or more of the study discontinuation or withdrawal criteria; or remain relapse-free during the double-blind phase until the study is terminated.

Participants will receive an SC injection of TV-46000 at baseline and q4w thereafter. The maximal dose for adult participants is comparable to an oral risperidone dose of 5 milligrams (mg)/day, and the maximal dose for adolescents is comparable to 4 mg/day. Participants will continue treatment until they experience a relapse event; meet 1 or more of the study discontinuation or withdrawal criteria; or remain relapse-free during the double-blind phase until the study is terminated.

Participants 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. The maximal dose for adult participants is comparable to an oral risperidone dose of 5 mg/day, and the maximal dose for adolescents is comparable to 4 mg/day. Participants will continue treatment until they experience a relapse event; meet 1 or more of the study discontinuation or withdrawal criteria; or remain relapse-free during the double-blind phase until the study is terminated.

Outcomes

Primary Outcome Measures

Time to Impending Relapse (Number of Participants With Impending Relapse) for Intent-to-treat [ITT] Analysis Set

Relapse was defined as 1 or more of the following items: • Clinical Global Impression-Improvement (CGI-I) of ≥5, and - an increase of any of the 4 Positive and Negative Syndrome Scale (PANSS) items: conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content, to a score of >4 with an absolute increase of ≥2 on specific item since randomization, or - an increase in any of the 4 individual PANSS items to a score of >4 and an absolute increase of ≥4 on combined score of 4 items since randomization; • hospitalization due to worsening of psychotic symptoms; • Clinical Global Impression-Severity of Suicidality (CGI-SS) of 4 (severely suicidal) or 5 (attempted suicide) on Part 1 and/or 6 (much worse) or 7 (very much worse) on Part 2; • violent behavior resulting in clinically significant self-injury, injury to another person, or property damage. Data is presented as distribution of relapsing participants (number of participants with impending relapse).

Secondary Outcome Measures

Time to Impending Relapse (Number of Participants With Impending Relapse) for Extended ITT [eITT] Analysis Set

Relapse was defined as 1 or more of the following items: • CGI-I of ≥5, and - an increase of any of the 4 PANSS items: conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content, to a score of >4 with an absolute increase of ≥2 on specific item since randomization, or - an increase in any of the 4 individual PANSS items to a score of >4 and an absolute increase of ≥4 on combined score of 4 items since randomization; • hospitalization due to worsening of psychotic symptoms; • CGI-SS of 4 (severely suicidal) or 5 (attempted suicide) on Part 1 and/or 6 (much worse) or 7 (very much worse) on Part 2; • violent behavior resulting in clinically significant self-injury, injury to another person, or property damage. Data is presented as distribution of relapsing participants (adults and adolescents) (number of participants with impending relapse).

Proportion of Participants With Impending Relapse

Relapse was defined as 1 or more of the following items: • CGI-I of ≥5, and - an increase of any of the 4 PANSS items: conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content, to a score of >4 with an absolute increase of ≥2 on specific item since randomization, or - an increase in any of the 4 individual PANSS items to a score of >4 and an absolute increase of ≥4 on combined score of 4 items since randomization; • hospitalization due to worsening of psychotic symptoms; • CGI-SS of 4 (severely suicidal) or 5 (attempted suicide) on Part 1 and/or 6 (much worse) or 7 (very much worse) on Part 2; • violent behavior resulting in clinically significant self-injury, injury to another person, or property damage. Impending relapse rate at Week 24 was estimated using the Kaplan-Meier product estimate.

Number of Participants Who Maintain Stability at the Endpoint

Stability is defined as meeting all of the following criteria for at least 4 consecutive weeks: outpatient status; PANSS total score ≤80; minimal presence of specific psychotic symptoms on the PANSS, as measured by a score of ≤4 on each of the following items: conceptual disorganization, suspiciousness, hallucinatory behavior, and unusual thought content; Clinical Global Impression of Severity (CGI-S) score ≤4 (moderately ill); and CGI-SS score ≤2 (mildly suicidal) on Part 1 and ≤5 (minimally worsened) on Part 2. The last valid participant assessment was used as the endpoint.

Number of Participants Achieving Remission at the Endpoint

The remission was achieved for participants who did not relapse during the study and for over a period of at least 6 months preceding the endpoint, maintained scores of = 3 on each of the 8 specific PANSS items: P1 (delusions), G9 (unusual thought content), P3 (hallucinatory behavior), P2 (conceptual disorganization), G5 (mannerisms/posturing), N1 (blunted affect), N4 (social withdrawal), and N6 (lack of spontaneity). The last valid participant assessment was used as the endpoint.

Observed Rate of Impending Relapse (Number of Participants With Impending Relapse) at the Endpoint

Relapse was defined as 1 or more of the following items: • CGI-I of ≥5, and - an increase of any of the 4 PANSS items: conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content, to a score of >4 with an absolute increase of ≥2 on specific item since randomization, or - an increase in any of the 4 individual PANSS items to a score of >4 and an absolute increase of ≥4 on combined score of 4 items since randomization; • hospitalization due to worsening of psychotic symptoms; • CGI-SS of 4 (severely suicidal) or 5 (attempted suicide) on Part 1 and/or 6 (much worse) or 7 (very much worse) on Part 2; • violent behavior resulting in clinically significant self-injury, injury to another person, or property damage. Observed rate of impending relapse was calculated as the number of participants who relapsed by endpoint divided by the number of participants in each treatment group, using the last valid participant assessment as the endpoint.

Time to Impending Relapse (Number of Participants With Impending Relapse) in the Adolescent Participants

Relapse was defined as 1 or more of the following items: • CGI-I of ≥5, and - an increase of any of the 4 PANSS items: conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content, to a score of >4 with an absolute increase of ≥2 on specific item since randomization, or - an increase in any of the 4 individual PANSS items to a score of >4 and an absolute increase of ≥4 on combined score of 4 items since randomization; • hospitalization due to worsening of psychotic symptoms; • CGI-SS of 4 (severely suicidal) or 5 (attempted suicide) on Part 1 and/or 6 (much worse) or 7 (very much worse) on Part 2; • violent behavior resulting in clinically significant self-injury, injury to another person, or property damage. Data is presented as distribution of relapsing participants (adolescents) (number of participants with impending relapse).

Change From Baseline in Drug Attitudes Inventory 10-item Version (DAI-10) Total Score at the Endpoint and End of Treatment

The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. The DAI-10 contains 6 items (1, 3, 4, 7, 9, and 10) that a participant who was fully adherent to the prescribed medication answered as "True" and 4 items (2, 5, 6, and 8) that a participant who was fully adherent to the prescribed medication answered as "False." A correct answer was scored +1 and an incorrect answer was scored -1. The total score was the sum of pluses and minuses, which ranged from -10 to 10 in increments of 2. A positive total score indicated a positive subjective response (compliant) and a negative total score indicated a negative subjective response (non-compliance). Higher scores denoted better compliance. The last valid participant assessment was used as the endpoint.

Change From Baseline in Schizophrenia Quality of Life Scale (SQLS) Total Score at the Endpoint and End of Treatment

The SQLS comprises 33 items categorized in 2 domains: psychosocial feelings (20 items) and cognition and vitality (13 items). The items were scored on a 5-point scale (1 - never, 2 - rarely, 3 - sometimes, 4 - often, 5 - always). Individual domain and total scores were standardized by scoring algorithm to a 0 (best health status) to 100 (worst health status) scale, with higher scores indicating comparatively lower quality of life. The last valid participant assessment was used as the endpoint.

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were defined as AEs occurring after the first dose of the study drug until 120 days after the last dose of study drug. Serious AEs 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.

Change From Baseline in Total Abnormal Involuntary Movement Scale (AIMS) Score at the End of Treatment

The AIMS is a 14-item scale that includes assessments of orofacial movements, extremity and truncal dyskinesia, examiner's judgment of global severity, subjective measures of awareness of movements and distress, and a yes/no assessment of problems concerning teeth and/or dentures. Total AIMS score is a sum of item 1 through 7. Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 0 (no dyskinesia) to 4 (severe dyskinesia) scale. Total AIMS score for Items 1-7 ranged from 0 to 28; with higher scores indicating greater severity of the condition.

Change From Baseline in Simpson-Angus Scale (SAS) Mean Score at the End of Treatment

The SAS is a 10-item instrument for the assessment of neuroleptic-induced parkinsonism. The items on the scale include measurements of hypokinesia, rigidity, glabellar reflex, tremor, and salivation. Each item was rated on a 5-point scale (0 [None/Normal] to 4 [Extreme/Severe]). The mean score was calculated by adding the individual item scores and dividing by 10. The total mean score ranged from 0-4, with a higher score indicating greater severity of symptoms.

Change From Baseline in Total Barnes Akathisia Rating Scale (BARS) Score at the End of Treatment

The BARS is an instrument that assesses the severity of drug-induced akathisia. The BARS includes 3 items for rating objective restless movements, subjective restlessness, and any subjective distress associated with akathisia that were scored on a 4-point scale of 0 (normal/no distress) to 3 (constant restlessness/severe distress). Total score was the sum of scores of each item and ranged from 0-9, with higher scores indicating greater severity of akathisia.

Number of Participants Reporting Suicidal Behavior and Suicidal Ideation Using Columbia-Suicide Severity Rating Scale (C-SSRS) at Baseline and Post-Baseline

The C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior was defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation was defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation.

Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Score at the End of Treatment

The CDSS is specifically designed to assess the level of depression separate from the positive, negative, and EPS in schizophrenia. This clinician-administered instrument consists of 9 items, each rated on a 4-point scale from 0 (absent) to 3 (severe) that were added together to form the total CDSS depression score of the participant. The total score ranged from 0-27, with higher scores indicating greater severity of the condition.

Change From Baseline in Clinical Global Impression-Severity of Suicidality (CGI-SS) Score at the End of Treatment

The CGI-SS scale provides an overall clinician-rated assessment of the risk of suicidality. The CGI-SS consists of a 5-point scale in Part 1 (the most severe level of suicidality experience) ranging from 1 (not at all suicidal) to 5 (attempted suicide) and a 7-point scale in Part 2 (change in participant suicidality) ranging from 1 (very much improved) to 7 (very much worse).

Plasma Concentration of Risperidone, 9-OH-risperidone, and Total Active Moiety (Sum of Risperidone and 9-OH-risperidone)

Full Information

NCT ID

NCT03503318

First Posted

April 9, 2018

Last Updated

February 8, 2023

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03503318

Brief Title

Study to Evaluate TV-46000 as Maintenance Treatment in Adult and Adolescent Participants With Schizophrenia

Acronym

RISE

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

April 27, 2018 (Actual)

Primary Completion Date

September 30, 2020 (Actual)

Study Completion Date

December 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

544 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

TV-46000 q1m

Arm Type

Experimental

Arm Description

Arm Title

TV-46000 q2m

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

TV-46000

Other Intervention Name(s)

Risperidone

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Time to Impending Relapse (Number of Participants With Impending Relapse) for Intent-to-treat [ITT] Analysis Set

Description

Time Frame

From randomization up to 108 weeks

Secondary Outcome Measure Information:

Title

Time to Impending Relapse (Number of Participants With Impending Relapse) for Extended ITT [eITT] Analysis Set

Description

Time Frame

From randomization up to 108 weeks

Title

Proportion of Participants With Impending Relapse

Description

Relapse was defined as 1 or more of the following items: • CGI-I of ≥5, and - an increase of any of the 4 PANSS items: conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content, to a score of >4 with an absolute increase of ≥2 on specific item since randomization, or - an increase in any of the 4 individual PANSS items to a score of >4 and an absolute increase of ≥4 on combined score of 4 items since randomization; • hospitalization due to worsening of psychotic symptoms; • CGI-SS of 4 (severely suicidal) or 5 (attempted suicide) on Part 1 and/or 6 (much worse) or 7 (very much worse) on Part 2; • violent behavior resulting in clinically significant self-injury, injury to another person, or property damage. Impending relapse rate at Week 24 was estimated using the Kaplan-Meier product estimate.

Time Frame

Week 24

Title

Number of Participants Who Maintain Stability at the Endpoint

Description

Time Frame

At the endpoint (up to 108 weeks)

Title

Number of Participants Achieving Remission at the Endpoint

Description

Time Frame

At Endpoint (up to 108 weeks)

Title

Observed Rate of Impending Relapse (Number of Participants With Impending Relapse) at the Endpoint

Description

Relapse was defined as 1 or more of the following items: • CGI-I of ≥5, and - an increase of any of the 4 PANSS items: conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content, to a score of >4 with an absolute increase of ≥2 on specific item since randomization, or - an increase in any of the 4 individual PANSS items to a score of >4 and an absolute increase of ≥4 on combined score of 4 items since randomization; • hospitalization due to worsening of psychotic symptoms; • CGI-SS of 4 (severely suicidal) or 5 (attempted suicide) on Part 1 and/or 6 (much worse) or 7 (very much worse) on Part 2; • violent behavior resulting in clinically significant self-injury, injury to another person, or property damage. Observed rate of impending relapse was calculated as the number of participants who relapsed by endpoint divided by the number of participants in each treatment group, using the last valid participant assessment as the endpoint.

Time Frame

At the Endpoint (up to 108 weeks)

Title

Time to Impending Relapse (Number of Participants With Impending Relapse) in the Adolescent Participants

Description

Relapse was defined as 1 or more of the following items: • CGI-I of ≥5, and - an increase of any of the 4 PANSS items: conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content, to a score of >4 with an absolute increase of ≥2 on specific item since randomization, or - an increase in any of the 4 individual PANSS items to a score of >4 and an absolute increase of ≥4 on combined score of 4 items since randomization; • hospitalization due to worsening of psychotic symptoms; • CGI-SS of 4 (severely suicidal) or 5 (attempted suicide) on Part 1 and/or 6 (much worse) or 7 (very much worse) on Part 2; • violent behavior resulting in clinically significant self-injury, injury to another person, or property damage. Data is presented as distribution of relapsing participants (adolescents) (number of participants with impending relapse).

Time Frame

From randomization up to 108 weeks

Title

Change From Baseline in Drug Attitudes Inventory 10-item Version (DAI-10) Total Score at the Endpoint and End of Treatment

Description

Time Frame

Baseline, endpoint and end of treatment (up to Week 108)

Title

Change From Baseline in Schizophrenia Quality of Life Scale (SQLS) Total Score at the Endpoint and End of Treatment

Description

Time Frame

Baseline, endpoint and end of treatment (up to Week 108)

Title

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Description

Time Frame

From randomization up to 120 days after last dose of study drug (up to Week 125)

Title

Change From Baseline in Total Abnormal Involuntary Movement Scale (AIMS) Score at the End of Treatment

Description

Time Frame

Baseline, end of treatment (up to 108 weeks)

Title

Change From Baseline in Simpson-Angus Scale (SAS) Mean Score at the End of Treatment

Description

Time Frame

Baseline, end of treatment (up to 108 weeks)

Title

Change From Baseline in Total Barnes Akathisia Rating Scale (BARS) Score at the End of Treatment

Description

Time Frame

Baseline, end of treatment (up to 108 weeks)

Title

Number of Participants Reporting Suicidal Behavior and Suicidal Ideation Using Columbia-Suicide Severity Rating Scale (C-SSRS) at Baseline and Post-Baseline

Description

Time Frame

Baseline, post-baseline (up to 108 weeks)

Title

Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Score at the End of Treatment

Description

Time Frame

Baseline, end of treatment (up to 108 weeks)

Title

Change From Baseline in Clinical Global Impression-Severity of Suicidality (CGI-SS) Score at the End of Treatment

Description

Time Frame

Baseline, end of treatment (up to 108 weeks)

Title

Plasma Concentration of Risperidone, 9-OH-risperidone, and Total Active Moiety (Sum of Risperidone and 9-OH-risperidone)

Time Frame

1 hour prior to dosing at Baseline (Day 1) and at the end of treatment visit (up to 108 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The participant has a diagnosis of schizophrenia for >1 year and has had ≥1 episode of relapse in the last 24 months. The participant has been responsive to an antipsychotic treatment (other than clozapine) in the past year based on discussions with family members or healthcare professionals. The participant has 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 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 drugs 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, or 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 Additional criteria apply, please contact the investigator for more information Exclusion Criteria: The participant has a current clinically significant Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, or amnestic or other cognitive disorders, or borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder. The participant is currently on clozapine or 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. 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 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 has previously participated in a Teva-sponsored clinical study with TV-46000. The participant is a pregnant or lactating female. The participant has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery). The participant has used an investigational drug within 3 months prior to screening or has participated in a non-drug clinical trial within 30 days prior to screening. Additional criteria apply, please contact the investigator for more information

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Teva Medical Expert, MD

Organizational Affiliation

Teva Branded Pharmaceutical Products R&D, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Teva Investigational Site 14769

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72211

Country

United States

Facility Name

Teva Investigational Site 14796

City

Rogers

State/Province

Arkansas

ZIP/Postal Code

72758

Country

United States

Facility Name

Teva Investigational Site 14811

City

Anaheim

State/Province

California

ZIP/Postal Code

92805

Country

United States

Facility Name

Teva Investigational Site 14794

City

Bellflower

State/Province

California

ZIP/Postal Code

90706

Country

United States

Facility Name

Teva Investigational Site 14776

City

Colton

State/Province

California

ZIP/Postal Code

92324

Country

United States

Facility Name

Teva Investigational Site 14767

City

Costa Mesa

State/Province

California

ZIP/Postal Code

92626

Country

United States

Facility Name

Teva Investigational Site 14802

City

Costa Mesa

State/Province

California

ZIP/Postal Code

92627

Country

United States

Facility Name

Teva Investigational Site 14773

City

Culver City

State/Province

California

ZIP/Postal Code

90230

Country

United States

Facility Name

Teva Investigational Site 14835

City

Garden Grove

State/Province

California

ZIP/Postal Code

92845

Country

United States

Facility Name

Teva Investigational Site 14774

City

Glendale

State/Province

California

ZIP/Postal Code

91206

Country

United States

Facility Name

Teva Investigational Site 14817

City

La Habra

State/Province

California

ZIP/Postal Code

90631

Country

United States

Facility Name

Teva Investigational Site 14771

City

Lemon Grove

State/Province

California

ZIP/Postal Code

91945

Country

United States

Facility Name

Teva Investigational Site 14823

City

Long Beach

State/Province

California

ZIP/Postal Code

90822

Country

United States

Facility Name

Teva Investigational Site 14816

City

Montclair

State/Province

California

ZIP/Postal Code

91763

Country

United States

Facility Name

Teva Investigational Site 14803

City

Norwalk

State/Province

California

ZIP/Postal Code

90650

Country

United States

Facility Name

Teva Investigational Site 14786

City

Oakland

State/Province

California

ZIP/Postal Code

94607

Country

United States

Facility Name

Teva Investigational Site 14797

City

Oceanside

State/Province

California

ZIP/Postal Code

92054

Country

United States

Facility Name

Teva Investigational Site 14827

City

Oceanside

State/Province

California

ZIP/Postal Code

92056-4515

Country

United States

Facility Name

Teva Investigational Site 14777

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Teva Investigational Site 14815

City

Pico Rivera

State/Province

California

ZIP/Postal Code

90660

Country

United States

Facility Name

Teva Investigational Site 14812

City

Riverside

State/Province

California

ZIP/Postal Code

92506

Country

United States

Facility Name

Teva Investigational Site 14785

City

San Bernardino

State/Province

California

ZIP/Postal Code

92408

Country

United States

Facility Name

Teva Investigational Site 14818

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Teva Investigational Site 14828

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Teva Investigational Site 14819

City

San Marcos

State/Province

California

ZIP/Postal Code

92078

Country

United States

Facility Name

Teva Investigational Site 14779

City

Santa Ana

State/Province

California

ZIP/Postal Code

92705

Country

United States

Facility Name

Teva Investigational Site 14788

City

Torrance

State/Province

California

ZIP/Postal Code

90502

Country

United States

Facility Name

Teva Investigational Site 14768

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Teva Investigational Site 14783

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Teva Investigational Site 14836

City

Hallandale Beach

State/Province

Florida

ZIP/Postal Code

33009

Country

United States

Facility Name

Teva Investigational Site 14787

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Facility Name

Teva Investigational Site 14814

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33018

Country

United States

Facility Name

Teva Investigational Site 14799

City

Lauderhill

State/Province

Florida

ZIP/Postal Code

33319

Country

United States

Facility Name

Teva Investigational Site 14832

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

Country

United States

Facility Name

Teva Investigational Site 14810

City

North Miami

State/Province

Florida

ZIP/Postal Code

33161

Country

United States

Facility Name

Teva Investigational Site 14831

City

Orange City

State/Province

Florida

ZIP/Postal Code

32763

Country

United States

Facility Name

Teva Investigational Site 14806

City

Orlando

State/Province

Florida

ZIP/Postal Code

32810

Country

United States

Facility Name

Teva Investigational Site 14837

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

Country

United States

Facility Name

Teva Investigational Site 14824

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30331

Country

United States

Facility Name

Teva Investigational Site 14834

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31904

Country

United States

Facility Name

Teva Investigational Site 14821

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30030

Country

United States

Facility Name

Teva Investigational Site 14770

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Teva Investigational Site 14765

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Teva Investigational Site 14829

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60640

Country

United States

Facility Name

Teva Investigational Site 14805

City

Hoffman Estates

State/Province

Illinois

ZIP/Postal Code

60169

Country

United States

Facility Name

Teva Investigational Site 14825

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71101

Country

United States

Facility Name

Teva Investigational Site 14764

City

Glen Burnie

State/Province

Maryland

ZIP/Postal Code

21061

Country

United States

Facility Name

Teva Investigational Site 14820

City

New Bedford

State/Province

Massachusetts

ZIP/Postal Code

02740

Country

United States

Facility Name

Teva Investigational Site 14798

City

Saginaw

State/Province

Michigan

ZIP/Postal Code

48603

Country

United States

Facility Name

Teva Investigational Site 14791

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63109

Country

United States

Facility Name

Teva Investigational Site 14813

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63128

Country

United States

Facility Name

Teva Investigational Site 14826

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63132

Country

United States

Facility Name

Teva Investigational Site 14790

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Teva Investigational Site 14809

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89102

Country

United States

Facility Name

Teva Investigational Site 14792

City

Berlin

State/Province

New Jersey

ZIP/Postal Code

08009

Country

United States

Facility Name

Teva Investigational Site 14830

City

Princeton

State/Province

New Jersey

ZIP/Postal Code

08540

Country

United States

Facility Name

Teva Investigational Site 14772

City

Cedarhurst

State/Province

New York

ZIP/Postal Code

11516

Country

United States

Facility Name

Teva Investigational Site 14804

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Teva Investigational Site 14800

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Teva Investigational Site 14784

City

New York

State/Province

New York

ZIP/Postal Code

10036

Country

United States

Facility Name

Teva Investigational Site 14780

City

Staten Island

State/Province

New York

ZIP/Postal Code

10312

Country

United States

Facility Name

Teva Investigational Site 14763

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Teva Investigational Site 14782

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45417

Country

United States

Facility Name

Teva Investigational Site 14822

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Teva Investigational Site 14789

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18104

Country

United States

Facility Name

Teva Investigational Site 14833

City

Norristown

State/Province

Pennsylvania

ZIP/Postal Code

19403

Country

United States

Facility Name

Teva Investigational Site 14775

City

Scranton

State/Province

Pennsylvania

ZIP/Postal Code

18503

Country

United States

Facility Name

Teva Investigational Site 14793

City

Thorndale

State/Province

Pennsylvania

ZIP/Postal Code

19372

Country

United States

Facility Name

Teva Investigational Site 14778

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

Facility Name

Teva Investigational Site 14781

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Teva Investigational Site 14766

City

Dallas

State/Province

Texas

ZIP/Postal Code

75243

Country

United States

Facility Name

Teva Investigational Site 14801

City

Houston

State/Province

Texas

ZIP/Postal Code

77081

Country

United States

Facility Name

Teva Investigational Site 14807

City

Irving

State/Province

Texas

ZIP/Postal Code

75062

Country

United States

Facility Name

Teva Investigational Site 59148

City

Bourgas

ZIP/Postal Code

8000

Country

Bulgaria

Facility Name

Teva Investigational Site 59152

City

Kazanlak

ZIP/Postal Code

6100

Country

Bulgaria

Facility Name

Teva Investigational Site 59151

City

Lovech

ZIP/Postal Code

5500

Country

Bulgaria

Facility Name

Teva Investigational Site 59149

City

Novi Iskar

ZIP/Postal Code

1282

Country

Bulgaria

Facility Name

Teva Investigational Site 59144

City

Sofia

ZIP/Postal Code

1680

Country

Bulgaria

Facility Name

Teva Investigational Site 59154

City

Varna

ZIP/Postal Code

9000

Country

Bulgaria

Facility Name

Teva Investigational Site 59150

City

Varna

ZIP/Postal Code

9020

Country

Bulgaria

Facility Name

Teva Investigational Site 59146

City

Vratsa

ZIP/Postal Code

3000

Country

Bulgaria

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.)

Learn more about this trial

Study to Evaluate TV-46000 as Maintenance Treatment in Adult and Adolescent Participants With Schizophrenia

We'll reach out to this number within 24 hrs

Study to Evaluate TV-46000 as Maintenance Treatment in Adult and Adolescent Participants With Schizophrenia (RISE)

Schizophrenia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial