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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pte Ltd
ClinicalTrials.gov Identifier:
NCT01527305
First received: February 2, 2012
Last updated: December 24, 2014
Last verified: December 2014
  Purpose

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).


Condition Intervention Phase
Schizophrenia
Drug: Paliperidone palmitate
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Prospective, Non-Comparative Study to Evaluate the Efficacy and Safety of Paliperidone Palmitate in Subjects With Acute Schizophrenia

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pte Ltd:

Primary Outcome Measures:
  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score [ Time Frame: Baseline (Week 0), Week 13 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 13 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline up to Week 13 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to Week 13 ] [ Designated as safety issue: No ]

Enrollment: 212
Study Start Date: June 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paliperidone palmitate Drug: Paliperidone palmitate
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 Name: Sustenna

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01527305

Locations
China
Huzhou, China
Shanghai, China
Shantou, China
Suzhou, China
Wenzhou, China
Wuxi, China
Korea, Republic of
Busan, Korea, Republic of
Goyang, Korea, Republic of
Gyeonggi-Do, Korea, Republic of
Jeonju-Si, Korea, Republic of
Kyounggi, Korea, Republic of
Seoul, Korea, Republic of
Suwon, Korea, Republic of
Malaysia
Johor Bahru, Malaysia
Kuala Lumpur, Malaysia
Tanjong Rambutan, Malaysia
Taiwan
Douliou City, Yunlin County, Taiwan
Kaohsiung, Taiwan
Kaohsiung City, Taiwan
New Taipei City, Taiwan
Taichung, Taiwan
Taipei, Taiwan
Sponsors and Collaborators
Johnson & Johnson Pte Ltd
Investigators
Study Director: Johnson & Johnson Pte Ltd Clinical Trial Johnson & Johnson Pte Ltd
  More Information

Additional Information:
No publications provided

Responsible Party: Johnson & Johnson Pte Ltd
ClinicalTrials.gov Identifier: NCT01527305     History of Changes
Other Study ID Numbers: CR100739, R092670SCH4009, PALM-KOR-4004, PALM-KOR-4003
Study First Received: February 2, 2012
Last Updated: December 24, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Johnson & Johnson Pte Ltd:
Schizophrenia
Antipsychotics
Paliperidone Palmitate
Paliperidone
Invega
Sustenna
Psychotic disorder
Psychosis

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
9-hydroxy-risperidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on July 01, 2015