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Completed

NCT Number: NCT01623713

Efficacy and Safety Study of Iloperidone Virus Risperidone to Treat Schizophrenia

The purpose of this study is to determine whether iloperidone is effective in the treatment of Schizophrenia.

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Key information

Conditions

Schizophrenia Efficacy Iloperidone Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sixth Hospital of Peking University

Beijing, Beijing Municipality, 100191, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men or women ages 18-65 years old.
  • DSM-IV diagnosis of schizophrenia.
  • PANSS≥70.
  • Of the 7 PANSS positive symptom subscale, at least two score ≥ 4 points.
  • Written informed consent.

Exclusion criteria

  • Pregnant or nursing (lactating) women, or women who plan on conceiving during the course of the study.
  • Clinically significant disease of the heart,kidneys,liver,hematonosis or endocrine system.

Treatment and study plan

iloperidone

Drug

Iloperidone is being development as a treatment of schizophrenia. This trial will verify the safety and efficacy of iloperidone in patients with schizophrenia.

Risperidone

Drug

Risperidone is used for the treatment of schizophrenia.Risperidone is unique among most other atypicals in that it has high affinity for the D2 receptor whereas most other atypicals have 'loose binding' of the D2 receptor. It has actions at several 5-HT (serotonin) receptor subtypes.

Primary outcomes

  1. Positive and Negative Symptom Scale(PANSS)-Total Score

    Time frame: 6 weeks

Secondary outcomes

  1. Effective percentage(PANSS score reduce rate≥50%)

    Time frame: 6 weeks

  2. Change in scores from baseline to end point assessment on the PANSS Positive subscale (PANSS-P)

    Time frame: 6 weeks

  3. Change in scores from baseline to end point assessment on the PANSS Negative subscale (PANSS-N)

    Time frame: 6 weeks

  4. Change in scores from baseline to end point assessment on the PANSS General Psychopathology subscale(PANSS-GP)

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Evaluate Efficacy and Safety Study of Iloperidone Virus Risperidone to Treat Schizophrenia

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 20, 2012
Registry last updated
Nov 19, 2013

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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