Identifying Predictors of Response to Antipsychotics Using a Treatment Algorithm

November 18, 2009 updated by: University of Sao Paulo

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

126

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403-010
        • Recruiting
        • Instituto de Psiquiatria - Hospital das Clinicas FMUSP
        • Sub-Investigator:
          • Monica Kayo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: First generation antipsychotic
Subjects randomized to this arm will receive treatment with haloperidol or chlorpromazine.
Drug: Antipsychotics
Quetiapine 25-800 mg; ziprasidone 80-160 mg; olanzapine 5-20mg; risperidone 2-8 mg; aripiprazole 15-30 mg
Other Names:
  • Seroquel, Geodon, Zyprexa, Abilify
Drug: Antipsychotics
Haloperidol 2,5-10 mg; chlorpromazine 25-600 mg.
EXPERIMENTAL: Second generation antipsychotics
Subjects randomized to this arm will receive treatment with a second-generation antipsychotic: risperidone or olanzapine or aripiprazole or quetiapine or ziprasidone
Drug: Antipsychotics
Quetiapine 25-800 mg; ziprasidone 80-160 mg; olanzapine 5-20mg; risperidone 2-8 mg; aripiprazole 15-30 mg
Other Names:
  • Seroquel, Geodon, Zyprexa, Abilify
Drug: Antipsychotics
Haloperidol 2,5-10 mg; chlorpromazine 25-600 mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
% responders to first generation antipsychotics vs. % responders to second generation antipsychotics
Time Frame: 8-12 weeks
8-12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
% of treatment abandon and respective causes
Time Frame: 8-12 weeks
8-12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (ANTICIPATED)

June 1, 2010

Study Completion (ANTICIPATED)

July 1, 2010

Study Registration Dates

First Submitted

November 18, 2009

First Submitted That Met QC Criteria

November 18, 2009

First Posted (ESTIMATE)

November 19, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 19, 2009

Last Update Submitted That Met QC Criteria

November 18, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Projesq-IPAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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