- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01527305
A Study to Evaluate the Effectiveness and Safety of Paliperidone Palmitate in Subjects With Acute Schizophrenia (PREVAIL)
December 24, 2014 updated by: Johnson & Johnson Pte Ltd
An Open-Label, Prospective, Non-Comparative Study to Evaluate the Efficacy and Safety of Paliperidone Palmitate in Subjects With Acute Schizophrenia
The purpose of this study is to evaluate the effectiveness and safety of paliperidone palmitate in schizophrenic inpatients who have experienced recent exacerbation of acute schizophrenia (that is within past 4 weeks).
Study Overview
Detailed Description
This is an open-label (all people know the identity of the intervention), prospective (looking forward using periodic observations collected predominantly following participant enrollment), non-comparative and multicenter study to evaluate the effectiveness and safety of paliperidone palmitate in acute schizophrenic participants.
This study consists of a screening phase (up to 7 days), treatment phase (13 weeks), and a study completion or early withdrawal visit.
Safety evaluations will include adverse events, clinical laboratory tests, concomitant medications, physical examination, and vital signs, which will be monitored throughout the study.
The total duration of study participation for each participant will be approximately 13 weeks.
Study Type
Interventional
Enrollment (Actual)
212
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Huzhou, China
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Shanghai, China
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Shantou, China
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Suzhou, China
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Wenzhou, China
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Wuxi, China
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Busan, Korea, Republic of
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Goyang, Korea, Republic of
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Gyeonggi-Do, Korea, Republic of
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Jeonju-Si, Korea, Republic of
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Kyounggi, Korea, Republic of
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Seoul, Korea, Republic of
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Suwon, Korea, Republic of
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Johor Bahru, Malaysia
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Kuala Lumpur, Malaysia
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Tanjong Rambutan, Malaysia
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Douliou City, Yunlin County, Taiwan
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Kaohsiung, Taiwan
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Kaohsiung City, Taiwan
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New Taipei City, Taiwan
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Taichung, Taiwan
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Taipei, Taiwan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have a current diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders Version IV (DSM-IV)
- Must be admitted to a hospital within 4 weeks prior to Screening experiencing an acute exacerbation of schizophrenia
- Have a positive and negative syndrome scale (PANSS) total score of more than or equal to 60 or clinical global impressions - severity (CGI-S) score of more than or equal to 4 (moderately ill) at Screening
- Agree to protocol-defined method of contraception
- Must be medically stable based on physical examination, medical history, vital signs, and clinical laboratory tests performed at Screening
Exclusion Criteria:
- Have a primary active DSM-IV Axis I diagnosis other than schizophrenia
- Have evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal, neurological, endocrine, metabolic or pulmonary disease in medical history, clinical laboratory or physical examination
- Have a history of neuroleptic malignant syndrome
- Participants at risk of suicide
- Have received clozapine within 1 month prior to Screening
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Paliperidone palmitate
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Participants will receive 1 intramuscular (into muscle) injection of 150 milligram (mg) on Day 1 and 1 injection of 100 mg on Day 8. Participants will also receive the last 2 paliperidone intramuscular injections between 50 - 150 mg (based on effectiveness and safety profile), on Day 36 and Day 64.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
Time Frame: Baseline (Week 0), Week 13
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The PANSS is scale of 30 items which includes 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items).
Each item is rated on a scale of 1 (absent) to 7 (extreme).
The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).
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Baseline (Week 0), Week 13
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With at Least a 30 Percent Reduction From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
Time Frame: Baseline, Week 13
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The PANSS is scale of 30 items which includes 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items).
Each item is rated on a scale of 1 (absent) to 7 (extreme).
The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).
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Baseline, Week 13
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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Factor Scores
Time Frame: Baseline, Week 13
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Marder factor scores of the PANSS, derived by factor-analysis includes 5 factors: negative symptom, positive symptom, disorganized thought, uncontrolled hostility/excitement, and anxiety/depression factor scales.
Positive factor score (range: 8 to 56): sum of select scores from positive, negative, and general psychopathology subscales.
Negative factor score (range: 7 to 49): sum of select scores from negative and general psychopathology subscales.
Disorganized thoughts factor score (range: 7 to 49): sum of select scores from positive, negative, and general psychopathology subscales.
Uncontrolled hostility/excitement factor score (range: 4 to 28): sum of select scores from positive and general psychopathology subscales.
Anxiety/Depression factor score (range: 4 to 28): sum of select scores from general psychopathology subscale.
Higher scores indicate worsening.
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Baseline, Week 13
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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores
Time Frame: Baseline, Week 13
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The PANSS is scale of 30 items which includes 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items).
The scale ranges from 1 (absent) to 7 (extreme).
Each item is rated on a scale of 1 (absent) to 7 (extreme).
The subscale score is the sum of scores of items in the subscale.
Positive subscale (range: 7 to 49), negative subscale (range: 7 to 49) and general psychopathology subscale (range: 16 to 112).
Higher scores indicate worsening.
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Baseline, Week 13
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Change From Baseline in Global Severity of Illness Using the Clinical Global Impression - Severity (CGI-S) Score
Time Frame: Baseline, Week 13
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The CGI-S rating scale is used to rate the severity of a participant's overall clinical condition on a 7-point scale ranging from 1 to 7 where 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, 7=Among the most extremely ill.
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Baseline, Week 13
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Change From Baseline in Personal and Social Performance (PSP) Scale Score
Time Frame: Baseline, Week 13
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The PSP assesses the overall personal and social functioning on a continuum from grossly impaired functioning to excellent functioning using 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior.
The degree of dysfunction a participant exhibits during the month prior to the assessment is rated on a 6-point scale (1=absent, 2=mild, 3=manifest, 4=marked, 5=severe, 6=very severe).
The final total score ranges from 1 - 100 (71 - 100 indicating mild, good or excellent degree of dysfunction, 31 - 70 indicating varying degrees of difficulty, and <=30 indicating such a poor level functioning that intensive supervision is required).
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Baseline, Week 13
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Time to Readiness for Hospitalization Discharge for Inpatients Using the Readiness for Discharge Questionnaire (RDQ) Scale
Time Frame: Baseline up to Week 13
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The 6-item RDQ consists of 5 items assessing suicidality/homicidality, control of aggression/impulsivity, activities of daily living, independence in medication-taking, delusions/hallucinations interfering with functioning, on a 4-point scale (1=strongly agree, 2=agree, 3=disagree, 4=strongly disagree), and 1 item assessing CGI-severity <=4 status using a binary (yes/no) response.
Using all 6 items as a guide, the clinician provides a final overall "yes/no" answer to the question 'is the participant ready for discharge'.
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Baseline up to Week 13
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Number of Participants With Drug Discontinuation
Time Frame: Up to Week 13
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Up to Week 13
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
February 2, 2012
First Submitted That Met QC Criteria
February 6, 2012
First Posted (Estimate)
February 7, 2012
Study Record Updates
Last Update Posted (Estimate)
December 25, 2014
Last Update Submitted That Met QC Criteria
December 24, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Paliperidone Palmitate
Other Study ID Numbers
- CR100739
- R092670SCH4009 (Other Identifier: Johnson & Johnson Pte Ltd.)
- PALM-KOR-4004 (Other Identifier: Johnson & Johnson Pte Ltd.)
- PALM-KOR-4003 (Other Identifier: Johnson & Johnson Pte Ltd.)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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