A Study to Evaluate the Effectiveness and Safety of Paliperidone Palmitate in Subjects With Acute Schizophrenia
Information source: Johnson & Johnson Pte Ltd
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Paliperidone palmitate (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Johnson & Johnson Pte Ltd Official(s) and/or principal investigator(s): Johnson & Johnson Pte Ltd Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pte Ltd
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).
Clinical Details
Official title: An Open-Label, Prospective, Non-Comparative Study to Evaluate the Efficacy and Safety of Paliperidone Palmitate in Subjects With Acute Schizophrenia
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
Secondary outcome: Number of Participants With at Least a 30 Percent Reduction From Baseline in Positive and Negative Syndrome Scale (PANSS) Total ScoreChange From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Factor Scores Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores Change From Baseline in Global Severity of Illness Using the Clinical Global Impression - Severity (CGI-S) Score Change From Baseline in Personal and Social Performance (PSP) Scale Score Time to Readiness for Hospitalization Discharge for Inpatients Using the Readiness for Discharge Questionnaire (RDQ) Scale Number of Participants With Drug Discontinuation
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Huzhou, China
Shanghai, China
Shantou, China
Suzhou, China
Wenzhou, China
Wuxi, China
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
Johor Bahru, Malaysia
Kuala Lumpur, Malaysia
Tanjong Rambutan, Malaysia
Douliou City, Yunlin County, Taiwan
Kaohsiung City, Taiwan
Kaohsiung, Taiwan
New Taipei City, Taiwan
Taichung, Taiwan
Taipei, Taiwan
Additional Information
An Open-label, Prospective, Non-comparative Study to Evaluate the Efficacy and Safety of Paliperidone Palmitate in Subjects with Acute Schizophrenia
Starting date: June 2012
Last updated: December 24, 2014
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