NCT00761189

Brief Summary

The purpose of this study is to evaluate the efficacy of paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
491

participants targeted

Target at P75+ for phase_4 schizophrenia

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

March 5, 2014

Completed
Last Updated

March 5, 2014

Status Verified

January 1, 2014

Enrollment Period

2.4 years

First QC Date

September 25, 2008

Results QC Date

January 22, 2014

Last Update Submit

January 22, 2014

Conditions

Schizophrenia

Keywords

PaliperidoneR076477Schizophrenia

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population

    The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.

    Week 12

  • Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Per Protocol (PP) Population

    The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.

    Week 12

Secondary Outcomes (10)

  • Personal and Social Performance (PSP) Scale Score - Intent-to-treat (ITT) Population

    Baseline, Week 4 and 12

  • Personal and Social Performance (PSP) Scale Score - Per Protocol (PP) Population

    Baseline, Week 4 and Week 12

  • Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Intent-to-treat (ITT) Population

    Week 12

  • Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Per Protocol (PP) Population

    Week 12

  • Drug Attitude Inventory (DAI) Score - Intent-to-treat (ITT) Population

    Baseline, Week 4 and 12

  • +5 more secondary outcomes

Study Arms (1)

Paliperidone

EXPERIMENTAL

Paliperidone extended-release (ER) tablet will be administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.

Drug: Paliperidone

Interventions

PaliperidoneDRUG

Paliperidone extended-release (ER) tablet will be administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.

Also known as: R076477, Invega extended-Release (ER) tablet
Paliperidone

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants with Clinical Global Impression-Severity (CGI-S) score greater than or equal to 4 points (moderately ill) at Screening
  • Childbearing potential women who consent to the consistent use of the acceptable contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
  • Participants who are capable of and willing to fill out the questionnaire for themselves
  • Participants who are compliant with self-medication or can receive consistent help or support
  • Have schizophrenia diagnosis by Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)

You may not qualify if:

  • Participants with the past history of neuroleptic malignant syndrome (NMS)
  • Participants with Treatment Resistance history who have failed to be properly treated with more than two other kinds of antipsychotic agents (at least 4 weeks of the therapeutic dose administration)
  • Participants with severe (pathologic or iatrogenic) gastrointestinal stenosis or participants who can not swallow the drug whole (The study drug must not be chewed, divided, melted or grinded because it can impact the study drug release profile.)
  • Participants who have been exposed to the study drug within one month before screening
  • Participants with significant risk including suicide or aggressive behavior

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Unknown Facility

Bucheon-Si Gyeonggi-Do, South Korea

Location

Unknown Facility

Changnyung, South Korea

Location

Unknown Facility

Chunjoo, South Korea

Location

Unknown Facility

Daejeon, South Korea

Location

Unknown Facility

Daejun, South Korea

Location

Unknown Facility

Geonggi-Do, South Korea

Location

Unknown Facility

Gyeonggi-do, South Korea

Location

Unknown Facility

Incheon, South Korea

Location

Unknown Facility

Inchun, South Korea

Location

Unknown Facility

Jinju, South Korea

Location

Unknown Facility

Jungnam, South Korea

Location

Unknown Facility

Kwangjoo, South Korea

Location

Unknown Facility

Kyounggi, South Korea

Location

Unknown Facility

Kyunggi-Do, South Korea

Location

Unknown Facility

Kyungju, South Korea

Location

Unknown Facility

Kyungki, South Korea

Location

Unknown Facility

Kyunki, South Korea

Location

Unknown Facility

Pusan, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Ulsan, South Korea

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Paliperidone PalmitateTablets

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesDosage FormsPharmaceutical Preparations

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
82-2094-4804

Study Officials

  • Janssen Korea, Ltd., Korea Clinical Trial

    Janssen Korea, Ltd., Korea

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes
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

February 1, 2008

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

March 5, 2014

Results First Posted

March 5, 2014

Record last verified: 2014-01

Locations

KR(20)