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

NCT01527305 | Completed Phase 4

• 4 other identifiers: CR100739R092670SCH4009PALM-KOR-4004PALM-KOR-4003
• Study Type: interventional
• Target: 212
• Locations: 4 countries
• Sites: 21

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).

Conditions

Schizophrenia

Keywords

Schizophrenia; Antipsychotics; Paliperidone Palmitate; Paliperidone; Invega; Sustenna; Psychotic disorder; Psychosis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score

  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). Each item is rated on a scale of 1 (absent) to 7 (extreme). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).

  Baseline (Week 0), Week 13

Secondary Outcomes (7)

• Number of Participants With at Least a 30 Percent Reduction From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score

  Baseline, Week 13

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Factor Scores

  Baseline, Week 13

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores

  Baseline, Week 13

• Change From Baseline in Global Severity of Illness Using the Clinical Global Impression - Severity (CGI-S) Score

  Baseline, Week 13

• Change From Baseline in Personal and Social Performance (PSP) Scale Score

  Baseline, Week 13

Study Arms (1)

Paliperidone palmitate

EXPERIMENTAL

Drug: Paliperidone palmitate

Interventions

Paliperidone palmitate 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.

Also known as: Sustenna

Paliperidone palmitate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (21)

Unknown Facility

Huzhou, China

Location

Unknown Facility

Shanghai, China

Location

Unknown Facility

Shantou, China

Location

Unknown Facility

Suzhou, China

Location

Unknown Facility

Wenzhou, China

Location

Unknown Facility

Wuxi, China

Location

Unknown Facility

Johor Bahru, Malaysia

Location

Unknown Facility

Kuala Lumpur, Malaysia

Location

Unknown Facility

Tanjong Rambutan, Malaysia

Location

Unknown Facility

Busan, South Korea

Location

Unknown Facility

Goyang, South Korea

Location

Unknown Facility

Gyeonggi-do, South Korea

Location

Unknown Facility

Jeonju, South Korea

Location

Unknown Facility

Kyounggi, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Suwon, South Korea

Location

Unknown Facility

Douliou City, Yunlin County, Taiwan

Location

Unknown Facility

Kaohsiung City, Taiwan

Location

Unknown Facility

New Taipei City, Taiwan

Location

Unknown Facility

Taichung, Taiwan

Location

Unknown Facility

Taipei, Taiwan

Location

Related Links

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

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2012
• First Posted: February 7, 2012
• Study Start: June 22, 2012
• Primary Completion: December 31, 2013
• Study Completion: December 31, 2013
• Last Updated: October 28, 2024

Record last verified: 2024-10

Locations

CN (6); KR (7); MY (3); TW (5)