Study to Evaluate TV-46000 as Maintenance Treatment in Adult and Adolescent Participants With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: TV-46000; Placebo
Intervention description: TV-46000 will be administered per dose and schedule specified in the arm.; Placebo matching to TV-46000 will be administered per schedule specified in the arm.
Intervention MeSH terms: Risperidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 544.0
Sex: All
Minimum age: 13 Years
Maximum age: 65 Years
Healthy volunteers: No

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
    

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