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Completed

NCT Number: NCT01157585

Efficacy and Safety of Paliperidone ER in First Episode Psychosis

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

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Key information

Conditions

First Episode Psychosis

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Paliperidone ER

Drug

8 week prospective study

Primary outcomes

  1. Symptoms assessment by objective rating scales

    Time frame: week 1

    PANSS total score, SANS, CGI

  2. Symptoms assessment by objective rating scales

    Time frame: week 2

    PANSS total score, SANS, CGI

  3. Symptoms assessment by objective rating scales

    Time frame: week 3

    PANSS total score, SANS, CGI

  4. Symptoms assessment by objective rating scales

    Time frame: week 4

    PANSS total score, SANS, CGI

  5. Symptoms assessment by objective rating scales

    Time frame: week 8

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

Secondary outcomes

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

    Time frame: week 1

    NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS

  2. Assessment of adverse events by objective rating scales and self report scales

    Time frame: week 2

    NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS

  3. Assessment of adverse events by objective rating scales and self report scales

    Time frame: week 4

    NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS, AIMS

  4. Assessment of adverse events by objective rating scales and self report scales

    Time frame: week 8

    NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS, AIMS, Lipid profile

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Collaborators

  • Janssen Korea, Ltd., Korea

Registry information

Official study title

Efficacy and Safety of Paliperidone ER in Patients With First Episode Psychosis: an Open-label, Prospective Multi-center Study

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 7, 2010
Registry last updated
Jul 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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