Antipsychotic to Treat Psychosis Syndrome

Central South University

Status: Unknown

Conditions: Psychotic Disorders

Treatments: Drug: Quetiapine; Drug: olanzapine; Drug: risperidone; Drug: Aripiprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT02137616

201002003 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 16 to 30 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 4 patient groups

risperidone

Active Comparator group

Description:

low dosage of antipsychotic drug

Treatment:

Drug: risperidone

olanzapine

Active Comparator group

Description:

low doseage of antipsychotic

Treatment:

Drug: olanzapine

quetiapine

Active Comparator group

Description:

low doseage of antipsychotic

Treatment:

Drug: Quetiapine

aripiprazole

Active Comparator group

Description:

low doseage of antipsychotic

Treatment:

Drug: Aripiprazole