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Antipsychotic to Treat Psychosis Syndrome

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02137616
Enrollment
300
Registered
2014-05-14
Start date
2012-06-30
Completion date
2014-12-31
Last updated
2014-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychotic Disorders

Keywords

psychosis, syndrome, risk, antipsychotic

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.

Interventions

DRUGrisperidone

Risperdal tablets

DRUGolanzapine

olanzapine tablets

DRUGQuetiapine

quetiapine tablets

DRUGAripiprazole

Aripiprazole tablets

Sponsors

Central South University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 30 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Changes of PANSS total scores from baseline to 18 months18 months

Secondary

MeasureTime frameDescription
Social function18 monthsSocial 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 Tolerability18 monthsAdverse Events were assessed at baseline and every month after treatments

Countries

China

Contacts

Primary Contactxiaofeng Guo, Dr.
fengcsu@yahoo.com.cn073185554052

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026