Study Stopped
This study was stopped due to an internal reconsideration of priorities of the product portfolio.
Twelve Month Study Comparing Paliperidone Palmitate and Select Oral Antipsychotics in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric Hospital
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
2 other identifiers
interventional
N/A
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2010
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 30, 2010
CompletedFirst Posted
Study publicly available on registry
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedJuly 8, 2013
July 1, 2013
2.1 years
August 30, 2010
July 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Up to 12 months
Secondary Outcomes (4)
Change in Clinical Global Impression-Severity score
Up to 12 months
Change in Global Assessment of Functionality score
Up to 12 months
Change in Medication Satisfaction Questionnaire score
Up to 12 months
Proportion of subjects with at least one psychiatric hospitalization
Up to 12 months
Study Arms (8)
001
EXPERIMENTALpaliperidone palmitate 78 117 156 or 234 mg monthly injection for 12 months
002
ACTIVE COMPARATORolanzapine flexible dosing as prescribed by the study doctor for 12 months
003
ACTIVE COMPARATORpaliperidone flexible dosing as prescribed by the study doctor for 12 months
004
ACTIVE COMPARATORaripiprazole flexible dosing as prescribed by the study doctor for 12 months
005
ACTIVE COMPARATORhaloperidole flexible dosing as prescribed by the study doctor for 12 months
006
ACTIVE COMPARATORperphenazine flexible dosing as prescribed by the study doctor for 12 months
007
ACTIVE COMPARATORquetiapine flexible dosing as prescribed by the study doctor for 12 months
008
ACTIVE COMPARATORrisperidone flexible dosing as prescribed by the study doctor for 12 months
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Ibragimov K, Keane GP, Carreno Glaria C, Cheng J, Llosa AE. Haloperidol (oral) versus olanzapine (oral) for people with schizophrenia and schizophrenia-spectrum disorders. Cochrane Database Syst Rev. 2024 Jul 3;7(7):CD013425. doi: 10.1002/14651858.CD013425.pub2.
PMID: 38958149DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial
Ortho-McNeil Janssen Scientific Affairs, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2010
First Posted
September 1, 2010
Study Start
August 1, 2010
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
July 8, 2013
Record last verified: 2013-07