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Twelve Month Study Comparing Paliperidone Palmitate and Select Oral Antipsychotics in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric Hospital

This study has been withdrawn prior to enrollment.
(This study was stopped due to an internal reconsideration of priorities of the product portfolio.)
Sponsor:
Information provided by (Responsible Party):
Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
NCT01193166
First received: August 30, 2010
Last updated: July 4, 2013
Last verified: July 2013
  Purpose

The study will assess the use of paliperidone palmitate compared with oral antipsychotic treatment in delaying time to a protocol-defined treatment failure over 12 months, in patients diagnosed with schizophrenia who were recently released from an inpatient psychiatric hospital.


Condition Intervention Phase
Schizophrenia
Drug: paliperidone palmitate
Drug: risperidone
Drug: olanzapine
Drug: aripiprazole
Drug: haloperidole
Drug: quetiapine
Drug: perphenazine
Drug: paliperidone
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 Twelve-Month, Prospective, Randomized, Active-Controlled, Open-Label, Flexible-Dose Study of Paliperidone Palmitate Compared With Oral Antipsychotic Treatment in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric Hospital

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Time to treatment failure defined as psychiatric hospitalization, suicide, discontinuation of treatment due to inadequate efficacy or safety/tolerability, treatment supplementation due to inadequate efficacy, or increase in psychiatric services [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Clinical Global Impression-Severity score [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Change in Global Assessment of Functionality score [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Change in Medication Satisfaction Questionnaire score [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Proportion of subjects with at least one psychiatric hospitalization [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: August 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 001
paliperidone palmitate 78 117 156 or 234 mg monthly injection for 12 months
Drug: paliperidone palmitate
78, 117, 156, or 234 mg monthly injection for 12 months
Active Comparator: 002
olanzapine flexible dosing as prescribed by the study doctor for 12 months
Drug: olanzapine
flexible dosing as prescribed by the study doctor for 12 months
Active Comparator: 003
paliperidone flexible dosing as prescribed by the study doctor for 12 months
Drug: paliperidone
flexible dosing as prescribed by the study doctor for 12 months
Active Comparator: 004
aripiprazole flexible dosing as prescribed by the study doctor for 12 months
Drug: aripiprazole
flexible dosing as prescribed by the study doctor for 12 months
Active Comparator: 005
haloperidole flexible dosing as prescribed by the study doctor for 12 months
Drug: haloperidole
flexible dosing as prescribed by the study doctor for 12 months
Active Comparator: 006
perphenazine flexible dosing as prescribed by the study doctor for 12 months
Drug: perphenazine
flexible dosing as prescribed by the study doctor for 12 months
Active Comparator: 007
quetiapine flexible dosing as prescribed by the study doctor for 12 months
Drug: quetiapine
flexible dosing as prescribed by the study doctor for 12 months
Active Comparator: 008
risperidone flexible dosing as prescribed by the study doctor for 12 months
Drug: risperidone
flexible dosing as prescribed by the study doctor for 12 months

Detailed Description:

The primary objective of this study will be to compare paliperidone palmitate treatment with the randomly assigned oral antipsychotic treatment in delaying time to treatment failure over 12 months in subjects diagnosed with schizophrenia who were recently discharged from an inpatient psychiatric hospital. Patients will receive either paliperidone palmitate 78, 117, 156, or 234 mg monthly by injection for twelve months OR oral aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone at doses selected by the study doctor.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be able to understand and sign the informed consent form approved by the Institutional Review Board (IRB)
  • Must be an outpatient who, following an acute exacerbation of schizophrenia, has been discharged from an inpatient psychiatric hospital within 60 days of screening
  • Have a current diagnosis of schizophrenia
  • Have available a designated individual who is likely to have knowledge of the subject's health status and who agrees to let the study site personnel know of changes in the patient's circumstances
  • Women must be postmenopausal (for at least 2 years), surgically sterile (hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), abstinent, or if sexually active, be practicing a highly effective method of birth control

Exclusion Criteria:

  • Allergies, hypersensitivity (anaphylaxis-type reaction), or intolerance to risperidone or paliperidone
  • Actively abusing intravenous drugs
  • Have a positive urine drug screen test for barbiturates, cocaine, amphetamines, or opiates at screening
  • have an unstable medical illness
  • Women who are pregnant or breast-feeding, or planning to become pregnant
  • Have received injectable antipsychotic treatment within 2 injection cycles prior to screening
  • Received treatment with clozapine within 3 months of screening
  • Attempted suicide within 6 months before screening or are at imminent risk of suicide or violent behavior, as clinically assessed by the investigator at time of screening
  • homeless at time of stuyd consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01193166

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: NCT01193166     History of Changes
Other Study ID Numbers: CR017110, R092670SCH4003
Study First Received: August 30, 2010
Last Updated: July 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Ortho-McNeil Janssen Scientific Affairs, LLC:
Schizophrenia
Risperidone
Risperdal
Paliperidone palmitate
Aripiprazole
Haloperidol
Olanzapine
Paliperidone
Perphenazine
Quetiapine

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
9-hydroxy-risperidone
Antipsychotic Agents
Aripiprazole
Olanzapine
Perphenazine
Quetiapine
Risperidone
Antiemetics
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Serotonin Uptake Inhibitors
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 25, 2014