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

NCT ID: NCT01527305

Last Updated: 2024-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-22
• Study Completion Date: 2013-12-31

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paliperidone palmitate

Group Type: EXPERIMENTAL

Paliperidone palmitate

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Sustenna

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Huzhou, , China

Shanghai, , China

Shantou, , China

Suzhou, , China

Wenzhou, , China

Wuxi, , China

Johor Bahru, , Malaysia

Kuala Lumpur, , Malaysia

Tanjong Rambutan, , Malaysia

Busan, , South Korea

Goyang, , South Korea

Gyeonggi-do, , South Korea

Jeonju, , South Korea

Kyounggi, , South Korea

Seoul, , South Korea

Suwon, , South Korea

Douliou City, Yunlin County, , Taiwan

Kaohsiung City, , Taiwan

New Taipei City, , Taiwan

Taichung, , Taiwan

Taipei, , Taiwan

Countries

China; Malaysia; South Korea; Taiwan

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=3404&filename=CR100739_CSR.pdf

An Open-label, Prospective, Non-comparative Study to Evaluate the Efficacy and Safety of Paliperidone Palmitate in Subjects with Acute Schizophrenia

Other Identifiers

R092670SCH4009

Identifier Type: OTHER

Identifier Source: secondary_id

PALM-KOR-4004

Identifier Type: OTHER

Identifier Source: secondary_id

PALM-KOR-4003

Identifier Type: OTHER

Identifier Source: secondary_id

CR100739

Identifier Type: -

Identifier Source: org_study_id