NCT00604279

Brief Summary

The purpose of this study is to compare the efficacy of paliperidone palmitate and risperidone long acting injection (LAI) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) along with safety and tolerability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
452

participants targeted

Target at P50-P75 for phase_3 schizophrenia

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_3 schizophrenia

Geographic Reach
1 country

8 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

January 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 30, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

July 10, 2013

Completed
Last Updated

July 10, 2013

Status Verified

June 1, 2013

Enrollment Period

1 year

First QC Date

January 17, 2008

Results QC Date

February 21, 2013

Last Update Submit

June 4, 2013

Conditions

Schizophrenia

Keywords

SchizophreniaPaliperidonePaliperidone palmitateRisperidoneRisperidone long acting injectionR092670

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 92 or Early Withdrawal

    The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 (absent) to 210 (extreme psychopathology). Higher change scores indicate worsening.

    Baseline, Day 92 or early withdrawal

Secondary Outcomes (4)

  • Change From Baseline in Personal and Social Performance (PSP) Score at Day 92 or Early Withdrawal

    Baseline, Day 92 or early withdrawal

  • Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Day 92 or Early Withdrawal

    Baseline, Day 92 or early withdrawal

  • Change From Baseline in the Sleep Visual Analog Scale (VAS) Score at Day 92 or Early Withdrawal

    Baseline, Day 92 or early withdrawal

  • Percentage of Participants Who Responded to PANSS Total Score at Day 92 or Early Withdrawal

    Day 92 or early withdrawal

Study Arms (2)

Paliperidone palmitate

EXPERIMENTAL

Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq.on Day 64 depending on investigator's discretion.

Drug: Paliperidone palmitate (R092670)

Risperidone long acting injection (LAI)

ACTIVE COMPARATOR

Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.

Drug: Risperidone

Interventions

Paliperidone palmitate (R092670)DRUG

Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq.on Day 64 depending on investigator's discretion.

Paliperidone palmitate
RisperidoneDRUG

Risperidone LAI intramuscular at a dose of 25 mg on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.

Risperidone long acting injection (LAI)

Eligibility Criteria

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

You may qualify if:

  • Participants who meet diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (disorganized type \[295.10\], catatonic type \[295.20\], paranoid type \[295.30\], residual type \[295.60\], or undifferentiated type \[295.90\]) for at least 1 year before screening and prior medical records, written documentation, or verbal information obtained from previous psychiatric providers obtained by the investigator must be consistent with the diagnosis of schizophrenia
  • A total Positive and Negative Syndrome Scale (PANSS) score between 60 and 120, inclusive, at screening and baseline
  • Body mass index (BMI) of equal to or greater than 17.0 kilogram per meter square (kg/m\^2)
  • Female participants must be postmenopausal for at least 2 years, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before study entry and throughout the study

You may not qualify if:

  • A primary, active DSM-IV diagnosis on Axis I other than schizophrenia
  • A decrease of at least 25 percent in the total PANSS score between screening and baseline
  • Participants who have previously participated in this study
  • History of treatment resistance as defined by failure to respond to 2 adequate treatments with different antipsychotic medications (an adequate treatment is defined as a minimum of 6 weeks at maximum tolerated dosage)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Baoding, China

Location

Unknown Facility

Beijing, China

Location

Unknown Facility

Guangzhou, China

Location

Unknown Facility

Hangzhou, China

Location

Unknown Facility

Nanjing, China

Location

Unknown Facility

Shanghai, China

Location

Unknown Facility

Wuhan, China

Location

Unknown Facility

Xi'an, China

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Paliperidone PalmitateRisperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesPyrimidinones

Results Point of Contact

Title
Local Trial Manager
Organization
Xian-Janssen Pharmaceutical Ltd
86-10-5821 8213

Study Officials

  • Xian-Janssen Pharmaceutical Ltd. Clinical Trial

    Xian-Janssen Pharmaceutical Ltd.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2008

First Posted

January 30, 2008

Study Start

January 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

July 10, 2013

Results First Posted

July 10, 2013

Record last verified: 2013-06

Locations

CN(8)