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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 Score

Change 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

Page last updated: August 23, 2015

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