A Study to Evaluate the Effectiveness and Safety of Paliperidone Palmitate in Patients With Acute Schizophrenia (PREVAIL)
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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 (ie, within past 4 weeks).
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Paliperidone palmitrate |
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 |
- Change from baseline in Positive And Negative Syndrome Scale (PANSS) [ Time Frame: Baseline (Week 0), Week 1, Week 5, 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).
- Number of patients with at least a 30% reduction from baseline in Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: Baseline, Week 1, Week 5, 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).
- Change from baseline in Positive And Negative Syndrome Scale (PANSS) Marder factor scores [ Time Frame: Baseline, Week 1, Week 5, 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).
- Change from baseline in Positive And Negative Syndrome Scale (PANSS) subscale scores [ Time Frame: Baseline, Week 1, Week 5, 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).
- Change from baseline in global severity of illness using the clinical global impression -severity (CGI-S) score [ Time Frame: Baseline, Week 1, Week 5, Week 9, Week 13 ] [ Designated as safety issue: No ]The CGI-S rating scale is used to rate the severity of a patient'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 degree of a patient's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =<30, functioning so poorly as to require intensive supervision.
- Time to readiness for hospitalization discharge for inpatients using the Readiness for Discharge Questionnaire (RDQ) scale [ Time Frame: Baseline, Week 1, Week 5, Week 9, Week 13 ] [ Designated as safety issue: No ]The RDQ is developed on principally the Discharge RDQ consists of 6 items assessing suicidality/homicidality, control of aggression/impulsivity, activities of daily living, medication-taking, delusions/hallucinations interfering with functioning and global status.
- Number of patients with drug discontinuation [ Time Frame: Up to Week 13 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 232 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Paliperidone palmitate |
Drug: Paliperidone palmitrate
Patients will receive one intramuscular (into muscle) injection of 150 mg on Day 1 and one injection of 100 mg on Day 8. Patients will also receive the last two 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 patient enrollment), non-comparative and multicenter study to evaluate the effectiveness and safety of paliperidone palmitate in acute schizophrenic patients. 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 patient will be approximately 13 weeks.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria: - Have a current diagnosis of schizophrenia
- 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
- Patients at risk of suicide
- Have received clozapine within 1 month prior to screening
Contacts and Locations| Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | JNJ.CT@sylogent.com |
| China | |
| Withdrawn | |
| Guangzhou, China | |
| Recruiting | |
| Huzhou, China | |
| Recruiting | |
| Shanghai, China | |
| Recruiting | |
| Suzhou, China | |
| Recruiting | |
| Wenzhou, China | |
| Withdrawn | |
| Wuhan, China | |
| Recruiting | |
| Wuxi, China | |
| Korea, Republic of | |
| Recruiting | |
| Busan, Korea, Republic of | |
| Recruiting | |
| Goyang, Korea, Republic of | |
| Recruiting | |
| Gyeonggi-Do, Korea, Republic of | |
| Recruiting | |
| Jeonju-Si, Korea, Republic of | |
| Recruiting | |
| Kyounggi, Korea, Republic of | |
| Recruiting | |
| Seoul, Korea, Republic of | |
| Recruiting | |
| Suwon, Korea, Republic of | |
| Malaysia | |
| Active, not recruiting | |
| Johor Bahru, Malaysia | |
| Recruiting | |
| Kuala Lumpur, Malaysia | |
| Recruiting | |
| Tanjong Rambutan, Malaysia | |
| Taiwan | |
| Recruiting | |
| Chiayi, Taiwan | |
| Recruiting | |
| Douliou City, Yunlin County, Taiwan | |
| Recruiting | |
| Kaohsiung, Taiwan | |
| Recruiting | |
| Kaohsiung City, Taiwan | |
| Recruiting | |
| New Taipei City, Taiwan | |
| Recruiting | |
| Taichung, Taiwan | |
| Recruiting | |
| Taipei, Taiwan | |
| 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: | May 6, 2013 |
| 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 Schizophrenia and Disorders with Psychotic Features Mental Disorders 9-hydroxy-risperidone Antipsychotic Agents Tranquilizing Agents |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 19, 2013