Antipsychotic to Treat Psychosis Syndrome
Overview
This study assess the safety and effects of atypical antipsychotics in subjects with psychosis syndrome and psychosis risk syndrome.
Full Title of Study: “Effectiveness of Antipsychotic Drugs to Treat Psychosis Syndrome: an Open Label, Controlled Study”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: None (Open Label)
- Study Primary Completion Date: December 2014
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
- Drug: risperidone
- Risperdal tablets
- Drug: olanzapine
- olanzapine tablets
- Drug: Quetiapine
- quetiapine tablets
- Drug: Aripiprazole
- Aripiprazole tablets
Arms, Groups and Cohorts
- Active Comparator: risperidone
- low dosage of antipsychotic drug
- Active Comparator: olanzapine
- low doseage of antipsychotic
- Active Comparator: quetiapine
- low doseage of antipsychotic
- Active Comparator: aripiprazole
- low doseage of antipsychotic
Clinical Trial Outcome Measures
Primary Measures
- Changes of PANSS total scores from baseline to 18 months
- Time Frame: 18 months
Secondary Measures
- Social function
- Time Frame: 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
- Time Frame: 18 months
- Adverse Events were assessed at baseline and every month after treatments
Participating in This Clinical Trial
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.
Gender Eligibility: All
Minimum Age: 16 Years
Maximum Age: 30 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Central South University
- Provider of Information About this Clinical Study
- Principal Investigator: xiaofeng Guo, prof. – Central South University
- Overall Official(s)
- xiaofeng Guo, Dr, Principal Investigator, the second xiangya hospitcal
- Overall Contact(s)
- xiaofeng Guo, Dr., 073185554052, fengcsu@yahoo.com.cn
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