Antipsychotic to Treat Psychosis Syndrome

Psychotic Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02137616
• Other study ID #: 201002003
• Status: Recruiting
• Phase: N/A
• First received: May 5, 2014
• Last updated: May 12, 2014
• Start date: June 2012
• Est. completion date: December 2014

Study information

• Verified date: May 2014
• Source: Central South University
• Contact: xiaofeng Guo, Dr.
• Phone: 073185554052
• Email: fengcsu[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 30 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders

Intervention

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

Locations

Country	Name	City	State
China	the Second Xiangya Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of PANSS total scores from baseline to 18 months		18 months	No
Secondary	Social function	Social function was assessed by the Global Assessment of Functioning (GAF) every three month	18 months	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Adverse Events were assessed at baseline and every month after treatments	18 months	Yes