Clinical trial NCT01527305: A Study to Evaluate the Effectiveness and Safety of Paliperidone Palmitate in Subjects With Acute Schizophrenia
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Antipsychotics
Paliperidone Palmitate
Paliperidone
Invega
Sustenna
Psychotic disorder
Psychosis
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2012-02-07
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
timeFrame: Baseline (Week 0), Week 13
Secondary outcomes:
measure: Number of Participants With at Least a 30 Percent Reduction From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
timeFrame: Baseline, Week 13
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Factor Scores
timeFrame: Baseline, Week 13
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores
timeFrame: Baseline, Week 13
measure: Change From Baseline in Global Severity of Illness Using the Clinical Global Impression - Severity (CGI-S) Score
timeFrame: Baseline, Week 13
measure: Change From Baseline in Personal and Social Performance (PSP) Scale Score
timeFrame: Baseline, Week 13
measure: Time to Readiness for Hospitalization Discharge for Inpatients Using the Readiness for Discharge Questionnaire (RDQ) Scale
timeFrame: Baseline up to Week 13
measure: Number of Participants With Drug Discontinuation
timeFrame: Up to Week 13
Other outcomes:
Locations:
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
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: