Antipsychotic to Treat Psychosis Syndrome

Overview

This study assess the safety and effects of atypical antipsychotics in subjects with psychosis syndrome and psychosis risk syndrome.

Full Title of Study: “Effectiveness of Antipsychotic Drugs to Treat Psychosis Syndrome: an Open Label, Controlled Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2014

Detailed Description

The investigators investigated whether administration of atypical antipsychotics could alleviate prodromal symptoms and be well tolerated by subjects with psychosis syndrome and psychosis risk syndrome.

Interventions

  • Drug: risperidone
    • Risperdal tablets
  • Drug: olanzapine
    • olanzapine tablets
  • Drug: Quetiapine
    • quetiapine tablets
  • Drug: Aripiprazole
    • Aripiprazole tablets

Arms, Groups and Cohorts

  • Active Comparator: risperidone
    • low dosage of antipsychotic drug
  • Active Comparator: olanzapine
    • low doseage of antipsychotic
  • Active Comparator: quetiapine
    • low doseage of antipsychotic
  • Active Comparator: aripiprazole
    • low doseage of antipsychotic

Clinical Trial Outcome Measures

Primary Measures

  • Changes of PANSS total scores from baseline to 18 months
    • Time Frame: 18 months

Secondary Measures

  • Social function
    • Time Frame: 18 months
    • Social function was assessed by the Global Assessment of Functioning (GAF) every three month
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability
    • Time Frame: 18 months
    • Adverse Events were assessed at baseline and every month after treatments

Participating in This Clinical Trial

Inclusion Criteria

  • were help-seeking young individuals in outpatients service – aged 16-30 years – fitted one of the following Criteria: Psychosis-risk Syndromes (COPS-SIPS) or Psychotic Syndrome (POPS-SIPS) or DSM-IV diagnosis of schizophreniform disorder Exclusion Criteria:

  • a previous diagnosis of any psychotic disorder or bipolar disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition; – symptoms fully accounted for by an Axis 1 disorder or sequelae of drug/alcohol use; – neurological disorders or organic disorders affecting the central nervous system, substance-related disorders or mental retardation as defined by the DSM-IV criteria; – history treatment of antipsychotic or antidepression, mood stabilizers or electroconvulsive therapy; – diagnosed as having a serious and unstable medical condition.

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 30 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Central South University
  • Provider of Information About this Clinical Study
    • Principal Investigator: xiaofeng Guo, prof. – Central South University
  • Overall Official(s)
    • xiaofeng Guo, Dr, Principal Investigator, the second xiangya hospitcal
  • Overall Contact(s)
    • xiaofeng Guo, Dr., 073185554052, fengcsu@yahoo.com.cn

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