NCT01670071

Brief Summary

The purpose of this study is to compare the effect of oral paliperidone extended-release and oral risperidone immediate-release on cognitive function, especially the category fluency of Cognitive Abilities Screening Instrument, Chinese version (CASI C-2.0), in patients with an established diagnosis of schizophrenia.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_4 schizophrenia

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

3 active sites

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

April 13, 2016

Status Verified

April 1, 2016

Enrollment Period

2.4 years

First QC Date

August 17, 2012

Last Update Submit

April 12, 2016

Conditions

Schizophrenia

Keywords

SchizophreniaPaliperidoneRisperidonePaliperidone extended-release (ER)Risperidone immediate-release (IR)

Outcome Measures

Primary Outcomes (1)

  • Change in category fluency score of cognitive function scale (Cognitive Abilities Screening Instrument, Chinese version [CASI C-2.0]) from baseline to Week 24

    CASI C-2.0 will be used to measure patient's cognitive ability. The range of CASI score is 0 to 100 (a higher score indicating better performance and is influenced by patient's educational level). The CASI C-2.0 provides quantitative assessment on 9 cognitive domains and 20 questions, including attention, concentration, orientation, short-term memory, long-term memory, language abilities, visual construction, category fluency, abstraction, and judgment.

    Baseline (Week 0), Week 4, Week 12 and Week 24

Secondary Outcomes (6)

  • Change from baseline to Week 24 in score of Modified Wisconsin Card Sorting Test (MWCST) short version

    Baseline, Week 4, Week 12 and Week 24

  • Change from baseline in score of Continuous Performance Test (CPT)

    Baseline, Week 4, Week 12 and Week 24

  • Change from baseline in score of Personal and Social Performance (PSP) scale

    Baseline, Week 4, Week 12 and Week 24

  • Change from baseline in score of Positive and Negative Syndrome Scale (PANSS)

    Baseline, Week 4, Week 12 and Week 24

  • Change from baseline in score of Clinical Global Impression-severity (CGI-S) scale

    Baseline, Week 4, Week 12 and Week 24

  • +1 more secondary outcomes

Study Arms (2)

Paliperidone extended-release

EXPERIMENTAL
Drug: Paliperidone extended-release

Risperidone immediate-release

ACTIVE COMPARATOR
Drug: Risperidone immediate-release

Interventions

Paliperidone extended-releaseDRUG

Patients will receive 6 mg to 12 mg of paliperidone extended-release tablet once daily orally.

Also known as: Paliperidone
Paliperidone extended-release
Risperidone immediate-releaseDRUG

Patients will receive 3 mg to 7 mg of risperidone immediate-release tablet orally.

Also known as: Risperidone IR
Risperidone immediate-release

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed with schizophrenia
  • Cognitive abilities screening instrument C-2.0 total score between 50 and 85 (inclusive) at baseline
  • Baseline positive and negative syndrome scale score between 60 and 85 (inclusive)
  • Clinical global impression-severity change less than or equal to 1 in the month prior to randomization
  • Patients on a stable therapeutic dose of oral risperidone IR (between 3-6 mg/day) for at least 4 weeks prior to randomization

You may not qualify if:

  • Treatment refractory patients, defined as failure of more than or equal to 2 adequate trials of second generation antipsychotic treatment for schizophrenia
  • History of neuroleptic malignant syndrome
  • Allergy or hypersensitivity to risperidone or paliperidone, or to any of the excipients of oral risperidone IR or paliperidone ER tablets
  • Participants who have taken paliperidone ER in the past
  • Participants who have been treated with clozapine or any long-acting injectable (depot) antipsychotic within 3 months before randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Bali Township, Taipei County, Taiwan

Location

Unknown Facility

Hualien City, Taiwan

Location

Unknown Facility

Kaohsiung City, Taiwan

Location

Related Links

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

Study Officials

  • Johnson & Johnson Taiwan Ltd Clinical Trial

    Johnson & Johnson Taiwan Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2012

First Posted

August 21, 2012

Study Start

January 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

April 13, 2016

Record last verified: 2016-04

Locations

TW(3)