Antipsychotic to Treat Psychosis Syndrome

NCT02137616 | Unknown DMC

• 1 other identifier: 201002003
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psychotic Disorders

Keywords

psychosis; syndrome; risk; antipsychotic

Outcome Measures

Primary Outcomes (1)

• Changes of PANSS total scores from baseline to 18 months

  18 months

Secondary Outcomes (2)

• Social function

  18 months

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  18 months

Study Arms (4)

risperidone

ACTIVE COMPARATOR

low dosage of antipsychotic drug

Drug: risperidone

olanzapine

ACTIVE COMPARATOR

low doseage of antipsychotic

Drug: olanzapine

quetiapine

ACTIVE COMPARATOR

low doseage of antipsychotic

Drug: Quetiapine

aripiprazole

ACTIVE COMPARATOR

low doseage of antipsychotic

Drug: Aripiprazole

Interventions

risperidone DRUG

Risperdal tablets

Also known as: Risperidol

risperidone

olanzapine DRUG

olanzapine tablets

Also known as: olanzapine tablets

olanzapine

Quetiapine DRUG

quetiapine tablets

Also known as: quetiapine tablets

quetiapine

Aripiprazole DRUG

Aripiprazole tablets

Also known as: Aripiprazole tablets

aripiprazole

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

the Second Xiangya Hospital

Changsha, Hunan, 410011, China

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders; Syndrome

Interventions

Risperidone; Olanzapine; Quetiapine Fumarate; Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Piperazines; Quinolones; Quinolines

Study Officials

• xiaofeng Guo, Dr

  the second xiangya hospitcal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xiaofeng Guo, Dr.

CONTACT

073185554052; fengcsu@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: May 14, 2014
• Study Start: June 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 14, 2014

Record last verified: 2014-05

Locations

CN (1)