NCT01157585

Brief Summary

The aim of the study is to investigate the efficacy and safety of Paliperidone ER in patients with first episode psychosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2010

Typical duration for phase_4

Geographic Reach
1 country

12 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, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

3 years

First QC Date

June 30, 2010

Last Update Submit

July 30, 2015

Conditions

First Episode Psychosis

Outcome Measures

Primary Outcomes (5)

  • Symptoms assessment by objective rating scales

    PANSS total score, SANS, CGI

    week 1

  • Symptoms assessment by objective rating scales

    PANSS total score, SANS, CGI

    week 2

  • Symptoms assessment by objective rating scales

    PANSS total score, SANS, CGI

    week 3

  • Symptoms assessment by objective rating scales

    PANSS total score, SANS, CGI

    week 4

  • Symptoms assessment by objective rating scales

    PANSS total score, SANS, CGI, CAI(Cognitive Assessment Interview)

    week 8

Secondary Outcomes (4)

  • Assessment of adverse events by objective rating scales and self report scales profile

    week 1

  • Assessment of adverse events by objective rating scales and self report scales

    week 2

  • Assessment of adverse events by objective rating scales and self report scales

    week 4

  • Assessment of adverse events by objective rating scales and self report scales

    week 8

Study Arms (1)

drug

OTHER
Drug: paliperidone ER

Interventions

paliperidone ERDRUG

8 week prospective study

drug

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18-59 years and meet DSM-IV diagnostic criteria for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version.

You may not qualify if:

  • Meeting DSM-IV criteria for another axis I diagnosis, including substance abuse or dependence
  • Needing another nonantipsychotic psychotropic medication at enrollment
  • Having a serious or unstable medical illness.
  • Pregnant or lactating women or women without adequate contraception will be also excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Department of Psychiatry, Korea University College of Medicine, Ansan Hospital

Ansan, South Korea

Location

Department of Psychiatry, Kangwon National University College of Medicine

Chunchon, South Korea

Location

Department of Psychiatry, Kyungpook national University School of Medicine

Daegu, South Korea

Location

Department of Psychiatry, Eulji University, School of Medicine

Daejeon, South Korea

Location

Department of Psychiatry, Chonnam National University Medical School

Hwasun, South Korea

Location

Department of Psychiatry, College of Medicine, Won-Kwang University

Iksan, South Korea

Location

Department of Psychiatry, Gachon University of Medicine and Science

Incheon, South Korea

Location

Department of Psychiatry, Chonbuk national University Hospital

Jeonju, 561-712, South Korea

Location

Department of Psychiatry, Myongji Hospital Kwandong Uni. college of Medicine

Koyang, South Korea

Location

St. John of God Neuropsychiatric Hospital

Kwangju, South Korea

Location

department of Neuropsychiatry. Dong-Eui University Medical Center

Pusan, South Korea

Location

Department of Neuropsychiatry, Soonchunhyang University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Paliperidone Palmitate

Intervention Hierarchy (Ancestors)

IsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

June 30, 2010

First Posted

July 7, 2010

Study Start

February 1, 2010

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

July 31, 2015

Record last verified: 2015-07

Locations

KR(12)