Identifying Predictors of Response to Antipsychotics Using a Treatment Algorithm

Schizophrenia or Schizoaffective Disorder Clinical Trial

Official title:

Identifying Predictors of Response in 12 Weeks of Treatment With Antipsychotics Using a Treatment Algorithm for Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01016145
• Other study ID #: Projesq-IPAP
• Status: Recruiting
• Phase: Phase 4
• First received: November 18, 2009
• Last updated: November 18, 2009
• Start date: April 2009
• Est. completion date: July 2010

Study information

• Verified date: November 2009
• Source: University of Sao Paulo
• Contact: Monica Kayo, MD
• Phone: 551130696971
• Email: monica.kayo[@]usp.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate predictors of response to antipsychotic medication in subjects with schizophrenia. The investigators will evaluate psychopathology,brain MRI, genetics and neuropsychological profile. Two groups of treatment will be compared: first generation antipsychotics vs. second generation antipsychotics. Participants will be randomized to one of the groups. Trial duration: 12 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Schizophrenia or schizoaffective disorder

• Age: 18-45 years olde

• Less than 10 years of diagnosis

• Acute exacerbation of psychotic symptoms

Exclusion Criteria:

• Use of clozapine

• Clinical unstable disease

• Delirium and cognitive disorders

Study Design

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

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizophrenia
• Schizophrenia or Schizoaffective Disorder

Intervention

Drug:
• Antipsychotics
Quetiapine 25-800 mg; ziprasidone 80-160 mg; olanzapine 5-20mg; risperidone 2-8 mg; aripiprazole 15-30 mg
• Antipsychotics
Haloperidol 2,5-10 mg; chlorpromazine 25-600 mg.

Locations

Country	Name	City	State
Brazil	Instituto de Psiquiatria - Hospital das Clinicas FMUSP	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% responders to first generation antipsychotics vs. % responders to second generation antipsychotics		8-12 weeks	No
Secondary	% of treatment abandon and respective causes		8-12 weeks	No