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Antipsychotic to Treat Psychosis Syndrome

Primary Purpose

Psychotic Disorders

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
risperidone
olanzapine
Quetiapine
Aripiprazole
Sponsored by
Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Psychotic Disorders focused on measuring psychosis, syndrome, risk, antipsychotic

Eligibility Criteria

16 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • the Second Xiangya HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

risperidone

olanzapine

quetiapine

aripiprazole

Arm Description

low dosage of antipsychotic drug

low doseage of antipsychotic

low doseage of antipsychotic

low doseage of antipsychotic

Outcomes

Primary Outcome Measures

Changes of PANSS total scores from baseline to 18 months

Secondary Outcome Measures

Social function
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
Adverse Events were assessed at baseline and every month after treatments

Full Information

First Posted
May 5, 2014
Last Updated
May 12, 2014
Sponsor
Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT02137616
Brief Title
Antipsychotic to Treat Psychosis Syndrome
Official Title
Effectiveness of Antipsychotic Drugs to Treat Psychosis Syndrome: an Open Label, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central South University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders
Keywords
psychosis, syndrome, risk, antipsychotic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
risperidone
Arm Type
Active Comparator
Arm Description
low dosage of antipsychotic drug
Arm Title
olanzapine
Arm Type
Active Comparator
Arm Description
low doseage of antipsychotic
Arm Title
quetiapine
Arm Type
Active Comparator
Arm Description
low doseage of antipsychotic
Arm Title
aripiprazole
Arm Type
Active Comparator
Arm Description
low doseage of antipsychotic
Intervention Type
Drug
Intervention Name(s)
risperidone
Other Intervention Name(s)
Risperidol
Intervention Description
Risperdal tablets
Intervention Type
Drug
Intervention Name(s)
olanzapine
Other Intervention Name(s)
olanzapine tablets
Intervention Description
olanzapine tablets
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Other Intervention Name(s)
quetiapine tablets
Intervention Description
quetiapine tablets
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Aripiprazole tablets
Intervention Description
Aripiprazole tablets
Primary Outcome Measure Information:
Title
Changes of PANSS total scores from baseline to 18 months
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Social function
Description
Social function was assessed by the Global Assessment of Functioning (GAF) every three month
Time Frame
18 months
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
Adverse Events were assessed at baseline and every month after treatments
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xiaofeng Guo, Dr.
Phone
073185554052
Ext
073185554052
Email
fengcsu@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xiaofeng Guo, Dr
Organizational Affiliation
the second xiangya hospitcal
Official's Role
Principal Investigator
Facility Information:
Facility Name
the Second Xiangya Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaofeng Guo, dr
Phone
073185554052
Ext
073185554052
Email
fengcsu@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
xiaofeng Guo, dr

12. IPD Sharing Statement

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Antipsychotic to Treat Psychosis Syndrome

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