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

• ClinicalTrials.gov Identifier: NCT03503318
• Recruitment Status: Completed
• First Posted: April 19, 2018
• Results First Posted: December 9, 2021
• Last Update Posted: March 10, 2023
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Information provided by (Responsible Party): Teva Branded Pharmaceutical Products R&D, Inc.

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

Condition or disease	Intervention/treatment	Phase
Schizophrenia	Drug: TV-46000; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 544 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: April 27, 2018
• Actual Primary Completion Date: September 30, 2020
• Actual Study Completion Date: December 3, 2020

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; 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.	Drug: Placebo; Placebo matching to TV-46000 will be administered per schedule specified in the arm.
Experimental: TV-46000 q1m; 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.	Drug: TV-46000; TV-46000 will be administered per dose and schedule specified in the arm.; Other Name: Risperidone
Experimental: TV-46000 q2m; 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.	Drug: TV-46000; TV-46000 will be administered per dose and schedule specified in the arm.; Other Name: Risperidone; Drug: Placebo; Placebo matching to TV-46000 will be administered per schedule specified in the arm.

Outcome Measures

Primary Outcome Measures :

1. Time to Impending Relapse (Number of Participants With Impending Relapse) for Intent-to-treat [ITT] Analysis Set [ Time Frame: From randomization up to 108 weeks ]
   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 :

1. Time to Impending Relapse (Number of Participants With Impending Relapse) for Extended ITT [eITT] Analysis Set [ Time Frame: From randomization up to 108 weeks ]
   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).
2. Proportion of Participants With Impending Relapse [ Time Frame: Week 24 ]
   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.
3. Number of Participants Who Maintain Stability at the Endpoint [ Time Frame: At the endpoint (up to 108 weeks) ]
   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.
4. Number of Participants Achieving Remission at the Endpoint [ Time Frame: At Endpoint (up to 108 weeks) ]
   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.
5. Observed Rate of Impending Relapse (Number of Participants With Impending Relapse) at the Endpoint [ Time Frame: At the Endpoint (up to 108 weeks) ]
   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.
6. Time to Impending Relapse (Number of Participants With Impending Relapse) in the Adolescent Participants [ Time Frame: From randomization up to 108 weeks ]
   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).
7. Change From Baseline in Drug Attitudes Inventory 10-item Version (DAI-10) Total Score at the Endpoint and End of Treatment [ Time Frame: Baseline, endpoint and end of treatment (up to Week 108) ]
   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.
8. Change From Baseline in Schizophrenia Quality of Life Scale (SQLS) Total Score at the Endpoint and End of Treatment [ Time Frame: Baseline, endpoint and end of treatment (up to Week 108) ]
   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.
9. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From randomization up to 120 days after last dose of study drug (up to Week 125) ]
   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.
10. Change From Baseline in Total Abnormal Involuntary Movement Scale (AIMS) Score at the End of Treatment [ Time Frame: Baseline, end of treatment (up to 108 weeks) ]
    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.
11. Change From Baseline in Simpson-Angus Scale (SAS) Mean Score at the End of Treatment [ Time Frame: Baseline, end of treatment (up to 108 weeks) ]
    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.
12. Change From Baseline in Total Barnes Akathisia Rating Scale (BARS) Score at the End of Treatment [ Time Frame: Baseline, end of treatment (up to 108 weeks) ]
    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.
13. Number of Participants Reporting Suicidal Behavior and Suicidal Ideation Using Columbia-Suicide Severity Rating Scale (C-SSRS) at Baseline and Post-Baseline [ Time Frame: Baseline, post-baseline (up to 108 weeks) ]
    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.
14. Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Score at the End of Treatment [ Time Frame: Baseline, end of treatment (up to 108 weeks) ]
    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.
15. Change From Baseline in Clinical Global Impression-Severity of Suicidality (CGI-SS) Score at the End of Treatment [ Time Frame: Baseline, end of treatment (up to 108 weeks) ]
    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).
16. 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) ]

Eligibility Criteria

• Ages Eligible for Study: 13 Years to 65 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Arkansas

Teva Investigational Site 14769

Little Rock, Arkansas, United States, 72211

Teva Investigational Site 14796

Rogers, Arkansas, United States, 72758

United States, California

Teva Investigational Site 14811

Anaheim, California, United States, 92805

Teva Investigational Site 14794

Bellflower, California, United States, 90706

Teva Investigational Site 14776

Colton, California, United States, 92324

Teva Investigational Site 14767

Costa Mesa, California, United States, 92626

Teva Investigational Site 14802

Costa Mesa, California, United States, 92627

Teva Investigational Site 14773

Culver City, California, United States, 90230

Teva Investigational Site 14835

Garden Grove, California, United States, 92845

Teva Investigational Site 14774

Glendale, California, United States, 91206

Teva Investigational Site 14817

La Habra, California, United States, 90631

Teva Investigational Site 14771

Lemon Grove, California, United States, 91945

Teva Investigational Site 14823

Long Beach, California, United States, 90822

Teva Investigational Site 14816

Montclair, California, United States, 91763

Teva Investigational Site 14803

Norwalk, California, United States, 90650

Teva Investigational Site 14786

Oakland, California, United States, 94607

Teva Investigational Site 14797

Oceanside, California, United States, 92054

Teva Investigational Site 14827

Oceanside, California, United States, 92056-4515

Teva Investigational Site 14777

Orange, California, United States, 92868

Teva Investigational Site 14815

Pico Rivera, California, United States, 90660

Teva Investigational Site 14812

Riverside, California, United States, 92506

Teva Investigational Site 14785

San Bernardino, California, United States, 92408

Teva Investigational Site 14818

San Diego, California, United States, 92103

Teva Investigational Site 14828

San Diego, California, United States, 92103

Teva Investigational Site 14819

San Marcos, California, United States, 92078

Teva Investigational Site 14779

Santa Ana, California, United States, 92705

Teva Investigational Site 14788

Torrance, California, United States, 90502

United States, Florida

Teva Investigational Site 14768

Coral Gables, Florida, United States, 33134

Teva Investigational Site 14783

Coral Gables, Florida, United States, 33134

Teva Investigational Site 14836

Hallandale Beach, Florida, United States, 33009

Teva Investigational Site 14787

Hialeah, Florida, United States, 33016

Teva Investigational Site 14814

Hialeah, Florida, United States, 33018

Teva Investigational Site 14799

Lauderhill, Florida, United States, 33319

Teva Investigational Site 14832

Miami, Florida, United States, 33126

Teva Investigational Site 14810

North Miami, Florida, United States, 33161

Teva Investigational Site 14831

Orange City, Florida, United States, 32763

Teva Investigational Site 14806

Orlando, Florida, United States, 32810

Teva Investigational Site 14837

Tampa, Florida, United States, 33614

United States, Georgia

Teva Investigational Site 14824

Atlanta, Georgia, United States, 30331

Teva Investigational Site 14834

Columbus, Georgia, United States, 31904

Teva Investigational Site 14821

Decatur, Georgia, United States, 30030

Teva Investigational Site 14770

Marietta, Georgia, United States, 30060

United States, Illinois

Teva Investigational Site 14765

Chicago, Illinois, United States, 60612

Teva Investigational Site 14829

Chicago, Illinois, United States, 60640

Teva Investigational Site 14805

Hoffman Estates, Illinois, United States, 60169

United States, Louisiana

Teva Investigational Site 14825

Shreveport, Louisiana, United States, 71101

United States, Maryland

Teva Investigational Site 14764

Glen Burnie, Maryland, United States, 21061

United States, Massachusetts

Teva Investigational Site 14820

New Bedford, Massachusetts, United States, 02740

United States, Michigan

Teva Investigational Site 14798

Saginaw, Michigan, United States, 48603

United States, Missouri

Teva Investigational Site 14791

Saint Louis, Missouri, United States, 63109

Teva Investigational Site 14813

Saint Louis, Missouri, United States, 63128

Teva Investigational Site 14826

Saint Louis, Missouri, United States, 63132

Teva Investigational Site 14790

Saint Louis, Missouri, United States, 63141

United States, Nevada

Teva Investigational Site 14809

Las Vegas, Nevada, United States, 89102

United States, New Jersey

Teva Investigational Site 14792

Berlin, New Jersey, United States, 08009

Teva Investigational Site 14830

Princeton, New Jersey, United States, 08540

United States, New York

Teva Investigational Site 14772

Cedarhurst, New York, United States, 11516

Teva Investigational Site 14804

New York, New York, United States, 10029

Teva Investigational Site 14800

New York, New York, United States, 10032

Teva Investigational Site 14784

New York, New York, United States, 10036

Teva Investigational Site 14780

Staten Island, New York, United States, 10312

United States, Ohio

Teva Investigational Site 14763

Cincinnati, Ohio, United States, 45219

Teva Investigational Site 14782

Dayton, Ohio, United States, 45417

United States, Oklahoma

Teva Investigational Site 14822

Oklahoma City, Oklahoma, United States, 73112

United States, Pennsylvania

Teva Investigational Site 14789

Allentown, Pennsylvania, United States, 18104

Teva Investigational Site 14833

Norristown, Pennsylvania, United States, 19403

Teva Investigational Site 14775

Scranton, Pennsylvania, United States, 18503

Teva Investigational Site 14793

Thorndale, Pennsylvania, United States, 19372

United States, South Carolina

Teva Investigational Site 14778

Charleston, South Carolina, United States, 29407

United States, Texas

Teva Investigational Site 14781

Dallas, Texas, United States, 75231

Teva Investigational Site 14766

Dallas, Texas, United States, 75243

Teva Investigational Site 14801

Houston, Texas, United States, 77081

Teva Investigational Site 14807

Irving, Texas, United States, 75062

Bulgaria

Teva Investigational Site 59148

Bourgas, Bulgaria, 8000

Teva Investigational Site 59152

Kazanlak, Bulgaria, 6100

Teva Investigational Site 59151

Lovech, Bulgaria, 5500

Teva Investigational Site 59149

Novi Iskar, Bulgaria, 1282

Teva Investigational Site 59144

Sofia, Bulgaria, 1680

Teva Investigational Site 59154

Varna, Bulgaria, 9000

Teva Investigational Site 59150

Varna, Bulgaria, 9020

Teva Investigational Site 59146

Vratsa, Bulgaria, 3000

Sponsors and Collaborators

Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

• Study Director: Teva Medical Expert, MD; Teva Branded Pharmaceutical Products R&D, Inc.

  Study Documents (Full-Text)

Documents provided by Teva Branded Pharmaceutical Products R&D, Inc.:

Study Protocol  [PDF] April 19, 2020

Statistical Analysis Plan  [PDF] December 16, 2020

More Information

• Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
• ClinicalTrials.gov Identifier: NCT03503318
• Other Study ID Numbers: TV46000-CNS-30072; 2018-001619-65 ( EudraCT Number )
• First Posted: April 19, 2018
• Results First Posted: December 9, 2021
• Last Update Posted: March 10, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.)

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Risperidone; Serotonin Antagonists; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs; Dopamine Antagonists; Dopamine Agents