28-30 Month Study Comparing Paliperidone Palmitate With Oral Risperidone for Treating Adults Diagnosed With Schizophrenia Within the Past 5 Years

Study Overview
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Brief Summary
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The study will assess the use of paliperidone palmitate compared with oral risperidone in delaying time to relapse in patients recently diagnosed with schizophrenia who are at high risk of relapse.

Detailed Description
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This is a Prospective, Randomized, Active-controlled, Rater-blinded Study to to assess the efficacy of paliperidone palmitate compared with oral risperidone in delaying time to relapse in patients recently diagnosed with schizophrenia who are at high risk of relapse. Recently diagnosed is defined as first diagnosis of any psychotic disorder within 5 years prior to screening. High risk of relapse is defined as having documented occurrence of 3 periods of breakthrough symptoms that required a change in patient care per the investigator's judgment (e.g., increase in dose, addition of a new drug, increase in the level of psychiatric care, notable increases in the frequency or intensity of patient contact required to maintain outpatient status, psychiatric hospitalization, etc.) within the previous 24 months, including 1 such period within the previous 6 months. Safety evaluations will include Adverse Event (AE) reporting, hematology and clinical chemistry laboratory tests, vital signs, electrocardiogram (ECG), and evaluations of suicidality and sexual functioning. Patients will receive either paliperidone palmitate 50, 75, 100, or 150 mg eq. monthly by injection for two years or oral risperidone 2, 4, 6, or 8 mg tabs once daily for two years.

Official Title
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A Prospective, Randomized, Active-controlled, Rater-blinded Study of the Prevention of Relapse Comparing Paliperidone Palmitate With Oral Risperidone in Adults With Recently-Diagnosed Schizophrenia Who Are at High Risk of Relapse

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: paliperidone palmitate
* Drug: oral risperidone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be, in the opinion of the investigator, able to understand the informed consent form approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC), as appropriate All patients must sign the study informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study Must have a current diagnosis of schizophrenia must have had 3 periods of breakthrough symptoms that required a change in patient care as determined by the investigator (e.g. increase in dose, addition of a new drug, hospitalization, increase in the level of psychiatric care, notable increases in the frequency or intensity of patient contact required to maintain outpatient status, etc.) within the previous 24 months, including 1 such period within the previous 6 months Women must be postmenopausal, surgically sterile, or otherwise be incapable of pregnancy, abstinent, or if sexually active, be practicing a highly effective method of birth control before entry, and must agree to continue to use the same method of contraception throughout the study Women of childbearing potential must have a negative urine pregnancy test at screening Patients must be cooperative and reliable, agree to receive regular injections, and be willing/able to adhere to the prohibitions and restrictions specified in this protocol. Exclusion Criteria: Patients who are unable to provide their own consent or are involuntarily committed to psychiatric hospitalization Have attempted suicide within 12 months before screening or are at imminent risk of suicide or violent behavior Have a positive urine drug screen test for barbiturates, cocaine, amphetamines, or opiates at screening Patients who are in their first episode of psychosis Patients currently meeting criteria for any other Axis I diagnosis except substance abuse or an Axis II diagnosis of Mental Retardation or Borderline Personality Disorder Meet the Diagnostic and Statistical Manual of Mental Health Disorders fourth edition (DSM-IV) definition of substance dependence (except for nicotine and caffeine dependence) within 6-months prior to entry Patients with known allergies, hypersensitivity (anaphylaxis-type reaction), or intolerance to paliperidone palmitate, risperidone, Risperdal®, Risperdal® Consta®, or INVEGA® or its excipients Patients who received Long Acting Therapy (LAT) treatment within 2 injection cycles prior to screening Women who are pregnant or breast-feeding, or planning to become pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 001<br>paliperidone palmitate 50 75 100 or 150 mg eq. monthly injection for 2 years | Drug: paliperidone palmitate<br>* 50, 75, 100, or 150 mg eq. monthly injection for 2 years<br>|
| Active Comparator: 002<br>oral risperidone 2 4 6 or 8 mg tabs once daily for two years | Drug: oral risperidone<br>* 2, 4, 6, or 8 mg tabs once daily for two years<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Relapse During Relapse Prevention Phase | Time to relapse during the relapse prevention phase was the primary efficacy variable of the study. Each case of potential relapse event were to be reviewed in a blinded fasion by an independent Relapse Monitoring Board, comprised of experts in the diagnostic, clinical and therapeutic management of schizophrenia. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Risperidone, Risperdal, Paliperidone Palmitate, Invega Sustenna