Antipsychotic to Treat Psychosis Syndrome

May 12, 2014 updated by: xiaofeng Guo, Central South University

Effectiveness of Antipsychotic Drugs to Treat Psychosis Syndrome: an Open Label, Controlled Study

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410011
        • Recruiting
        • The second xiangya hospital
        • Contact:
        • Principal Investigator:
          • xiaofeng Guo, dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 28 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: risperidone
low dosage of antipsychotic drug
Drug: risperidone
Risperdal tablets
Other Names:
  • Risperidol
Active Comparator: olanzapine
low doseage of antipsychotic
Drug: olanzapine
olanzapine tablets
Other Names:
  • olanzapine tablets
Active Comparator: quetiapine
low doseage of antipsychotic
Drug: Quetiapine
quetiapine tablets
Other Names:
  • quetiapine tablets
Active Comparator: aripiprazole
low doseage of antipsychotic
Drug: Aripiprazole
Aripiprazole tablets
Other Names:
  • Aripiprazole tablets

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social function
Time Frame: 18 months
Social function was assessed by the Global Assessment of Functioning (GAF) every three month
18 months
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
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central South University

Investigators

  • Principal Investigator: xiaofeng Guo, Dr, the second xiangya hospitcal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

May 5, 2014

First Submitted That Met QC Criteria

May 12, 2014

First Posted (Estimate)

May 14, 2014

Study Record Updates

Last Update Posted (Estimate)

May 14, 2014

Last Update Submitted That Met QC Criteria

May 12, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201002003 (Other Grant/Funding Number: the R&D Special Fund for Health Profession in China)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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