Antipsychotic to Treat Psychosis Syndrome

Not Applicable

• Conditions: Psychotic Disorders
• Interventions: Drug: Quetiapine; Drug: risperidone; Drug: olanzapine; Drug: Aripiprazole

• Registration Number: NCT02137616
• Lead Sponsor: Central South University

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.

Study Timeline

• Study Start: 2012-06
• Status Verified: 2014-05
• Study First Submitted: 2014-05-05
• Study First Submitted QC: 2014-05-12
• Last Update Submitted: 2014-05-12
• Study First Posted: 2014-05-14
• Last Update Posted: 2014-05-14
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
quetiapine	Quetiapine	low doseage of antipsychotic
risperidone	risperidone	low dosage of antipsychotic drug
olanzapine	olanzapine	low doseage of antipsychotic
aripiprazole	Aripiprazole	low doseage of antipsychotic

Primary Outcome Measures

Name	Time	Method
Changes of PANSS total scores from baseline to 18 months	18 months

Secondary Outcome Measures

Name	Time	Method
Social function	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	18 months	Adverse Events were assessed at baseline and every month after treatments

Trial Locations

Locations (1)

the Second Xiangya Hospital; 🇨🇳 Changsha, Hunan, China