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A Study to Evaluate the Effectiveness and Safety of Paliperidone Palmitate in Subjects With Acute Schizophrenia (PREVAIL)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Paliperidone palmitate
Sponsored by
Johnson & Johnson Pte Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Antipsychotics, Paliperidone Palmitate, Paliperidone, Invega, Sustenna, Psychotic disorder, Psychosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paliperidone palmitate

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
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).

Secondary Outcome Measures

Number of Participants With at Least a 30 Percent Reduction From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
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).
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Factor Scores
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.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores
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.
Change From Baseline in Global Severity of Illness Using the Clinical Global Impression - Severity (CGI-S) Score
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.
Change From Baseline in Personal and Social Performance (PSP) Scale Score
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).
Time to Readiness for Hospitalization Discharge for Inpatients Using the Readiness for Discharge Questionnaire (RDQ) Scale
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'.
Number of Participants With Drug Discontinuation

Full Information

First Posted
February 2, 2012
Last Updated
December 24, 2014
Sponsor
Johnson & Johnson Pte Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01527305
Brief Title
A Study to Evaluate the Effectiveness and Safety of Paliperidone Palmitate in Subjects With Acute Schizophrenia
Acronym
PREVAIL
Official Title
An Open-Label, Prospective, Non-Comparative Study to Evaluate the Efficacy and Safety of Paliperidone Palmitate in Subjects With Acute Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Pte Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Antipsychotics, Paliperidone Palmitate, Paliperidone, Invega, Sustenna, Psychotic disorder, Psychosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paliperidone palmitate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Paliperidone palmitate
Other Intervention Name(s)
Sustenna
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
Description
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).
Time Frame
Baseline (Week 0), Week 13
Secondary Outcome Measure Information:
Title
Number of Participants With at Least a 30 Percent Reduction From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
Description
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).
Time Frame
Baseline, Week 13
Title
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Factor Scores
Description
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.
Time Frame
Baseline, Week 13
Title
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores
Description
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.
Time Frame
Baseline, Week 13
Title
Change From Baseline in Global Severity of Illness Using the Clinical Global Impression - Severity (CGI-S) Score
Description
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.
Time Frame
Baseline, Week 13
Title
Change From Baseline in Personal and Social Performance (PSP) Scale Score
Description
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).
Time Frame
Baseline, Week 13
Title
Time to Readiness for Hospitalization Discharge for Inpatients Using the Readiness for Discharge Questionnaire (RDQ) Scale
Description
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'.
Time Frame
Baseline up to Week 13
Title
Number of Participants With Drug Discontinuation
Time Frame
Up to Week 13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pte Ltd Clinical Trial
Organizational Affiliation
Johnson & Johnson Pte Ltd
Official's Role
Study Director
Facility Information:
City
Huzhou
Country
China
City
Shanghai
Country
China
City
Shantou
Country
China
City
Suzhou
Country
China
City
Wenzhou
Country
China
City
Wuxi
Country
China
City
Busan
Country
Korea, Republic of
City
Goyang
Country
Korea, Republic of
City
Gyeonggi-Do
Country
Korea, Republic of
City
Jeonju-Si
Country
Korea, Republic of
City
Kyounggi
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
City
Suwon
Country
Korea, Republic of
City
Johor Bahru
Country
Malaysia
City
Kuala Lumpur
Country
Malaysia
City
Tanjong Rambutan
Country
Malaysia
City
Douliou City, Yunlin County
Country
Taiwan
City
Kaohsiung City
Country
Taiwan
City
Kaohsiung
Country
Taiwan
City
New Taipei City
Country
Taiwan
City
Taichung
Country
Taiwan
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=3404&filename=CR100739_CSR.pdf
Description
An Open-label, Prospective, Non-comparative Study to Evaluate the Efficacy and Safety of Paliperidone Palmitate in Subjects with Acute Schizophrenia

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A Study to Evaluate the Effectiveness and Safety of Paliperidone Palmitate in Subjects With Acute Schizophrenia

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