Phase 4 Study to Evaluate Efficacy of Paliperidone Extended-Release(ER) in Schizophrenic Participants

NCT00761605 | Completed Phase 4 Results

• 2 other identifiers: CR015253PAL-KOR-4003
• Study Type: interventional
• Target: 387
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to investigate the efficacy of flexibly dosed paliperidone extended-release (mechanism to dissolve a drug over time in order to be released slower and steadier into the blood stream) in improving or maintaining the subjective symptoms of the participants in three participants' groups (that is, by the reason to switch: lack of efficacy group, lack of tolerability group, and lack of compliance group) who switched from other previous antipsychotic drugs to paliperidone extended-release tablets at flexible doses.

Conditions

Schizophrenia

Keywords

Schizophrenia; Paliperidone; Paliperidone extended-release; Antipsychotics Agents

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24

  The SCL90-R (Derogatis, 1992) measures 9 domains, including somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, which provides a global index of distress, the Global Severity Index (GSI). SCL-90-R includes 90 items rated on 5-point scale, ranging from 0 (not at all) to 4 (extremely). Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.

  Baseline and Week 24

Secondary Outcomes (7)

• Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24

  Baseline and Week 24

• Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24

  Baseline and Week 24

• Change From Baseline in Sleep Quality Based on Visual Analog Scale at Week 24

  Baseline and Week 24

• Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale at Week 24

  Baseline and Week 24

• Change From Baseline in Krawiecka Scale Score at Week 24

  Baseline and Week 24

Study Arms (1)

Paliperidone

EXPERIMENTAL

Paliperidone oral tablet will be administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.

Drug: Paliperidone

Interventions

Paliperidone DRUG

Paliperidone oral tablet will be administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.

Also known as: R076477, Invega Extended-release tablet

Paliperidone

Eligibility Criteria

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

You may qualify if:

• Childbearing potential women who consent to the use of the consistently permissible contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
• Participants who are compliant with self-medication or can receive consistent help or support
• Participants who need to change the antipsychotic drug to another one for the following reasons among the participants treated with an antipsychotic drug for more than two weeks before the screening (1) Group of lack of efficacy: The antipsychotic drug is clinically required to be changed because there is no or little therapeutic response despite the appropriately dosed antipsychotic therapy (2) Group of lack of tolerance: The antipsychotic drug is required to be changed due to lack of tolerance to the existing antipsychotic drug or the safety issue (3) Group of lack of compliance: The antipsychotic drug is required to be changed due to lack of medication compliance or the participant wants to change the antipsychotic drug)

You may not qualify if:

• Participants with the past history of neuroleptic malignant syndrome (NMS)
• Participants who are suspicious of having clinically significant risk including suicide or aggressive behavior and are expected to unable to complete the study (based on the investigator's judgment)
• Participants with severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or participants who cannot swallow the drug whole (The study drug must not be chewed, divided, melted or grinded because it can impact the study drug release profile
• Female participants who are pregnant or are breast feeding
• Participants who have participated in any investigational drug trial within 1 month prior to the screening visit

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

Study Sites (8)

Unknown Facility

Chunchun, South Korea

Location

Unknown Facility

Incheon, South Korea

Location

Unknown Facility

Inchun, South Korea

Location

Unknown Facility

Kangwondo, South Korea

Location

Unknown Facility

Kyunggido, South Korea

Location

Unknown Facility

Kyungki, South Korea

Location

Unknown Facility

Kyunki, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Conditions

Schizophrenia

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

Limitations and Caveats

Some Adverse Events summaries were reported based on estimates due to the fact that they were not prepared in the original study report and the relevant definitions of the data elements were not available for these summaries to be regenerated.

Results Point of Contact

• Title: Senior Clinical Research Associate
• Organization: Clinical Research Team, Medical Affairs Korea

82-2-2094-4804

Study Officials

• Janssen Korea, Ltd., Korea Clinical Trial

  Janssen Korea, Ltd., Korea

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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: September 25, 2008
• First Posted: September 29, 2008
• Study Start: April 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: October 1, 2010
• Last Updated: September 10, 2014
• Results First Posted: March 6, 2014

Record last verified: 2014-09

Locations

KR (8)