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

Purpose

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.

Condition	Intervention	Phase
Schizophrenia	Drug: paliperidone palmitate Drug: oral risperidone	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Risperidone Paliperidone Paliperidone Palmitate

U.S. FDA Resources

Further study details as provided by Ortho-McNeil Janssen Scientific Affairs, LLC:

Primary Outcome Measures:

Time to Relapse During Relapse Prevention Phase [ Time Frame: 24 months ] [ Designated as safety issue: No ]
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.

Enrollment:	163
Study Start Date:	June 2009
Study Completion Date:	March 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 001 paliperidone palmitate 50 75 100 or 150 mg eq. monthly injection for 2 years	Drug: paliperidone palmitate 50, 75, 100, or 150 mg eq. monthly injection for 2 years
Active Comparator: 002 oral risperidone 2 4 6 or 8 mg tabs once daily for two years	Drug: oral risperidone 2, 4, 6, or 8 mg tabs once daily for two years

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00946985

Show 76 Study Locations

Sponsors and Collaborators

Ortho-McNeil Janssen Scientific Affairs, LLC

Investigators

Study Director:

Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial

Ortho-McNeil Janssen Scientific Affairs, LLC

More Information

No publications provided

Responsible Party:	Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:	NCT00946985 History of Changes
Other Study ID Numbers:	CR015646, R092670SCH3004
Study First Received:	July 2, 2009
Results First Received:	March 8, 2011
Last Updated:	September 3, 2012
Health Authority:	United States: Food and Drug Administration Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Ortho-McNeil Janssen Scientific Affairs, LLC:

Schizophrenia
Risperidone
Risperdal
Paliperidone Palmitate
Invega Sustenna

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
9-hydroxy-risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 16, 2013