Antipsychotic to Treat Psychosis Syndrome

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

Detailed Description
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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.

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

Conditions
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Psychotic Disorders

Intervention / Treatment
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* Drug: risperidone
* Drug: olanzapine
* Drug: Quetiapine
* Drug: Aripiprazole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: risperidone<br>low dosage of antipsychotic drug | Drug: risperidone<br>* Risperdal tablets<br>* Other names: Risperidol;|
| Active Comparator: olanzapine<br>low doseage of antipsychotic | Drug: olanzapine<br>* olanzapine tablets<br>* Other names: olanzapine tablets;|
| Active Comparator: quetiapine<br>low doseage of antipsychotic | Drug: Quetiapine<br>* quetiapine tablets<br>* Other names: quetiapine tablets;|
| Active Comparator: aripiprazole<br>low doseage of antipsychotic | Drug: Aripiprazole<br>* Aripiprazole tablets<br>* Other names: Aripiprazole tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of PANSS total scores from baseline to 18 months |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social function | Social function was assessed by the Global Assessment of Functioning (GAF) every three month | 18 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychosis, syndrome, risk, antipsychotic