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Identifying Predictors of Response to Antipsychotics Using a Treatment Algorithm

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01016145
Recruitment Status : Unknown
Verified November 2009 by University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : November 19, 2009
Last Update Posted : November 19, 2009
Information provided by:
University of Sao Paulo

Brief 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.

Condition or disease Intervention/treatment Phase
Schizophrenia or Schizoaffective Disorder Drug: Antipsychotics Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Identifying Predictors of Response in 12 Weeks of Treatment With Antipsychotics Using a Treatment Algorithm for Schizophrenia
Study Start Date : April 2009
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Active Comparator: First generation antipsychotic
Subjects randomized to this arm will receive treatment with haloperidol or chlorpromazine.
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 Name: Seroquel, Geodon, Zyprexa, Abilify

Primary Outcome Measures :
  1. % responders to first generation antipsychotics vs. % responders to second generation antipsychotics [ Time Frame: 8-12 weeks ]

Secondary Outcome Measures :
  1. % of treatment abandon and respective causes [ Time Frame: 8-12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01016145

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Contact: Monica Kayo, MD 551130696971
Contact: Helio Elkis, PhD 551130696971

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Instituto de Psiquiatria - Hospital das Clinicas FMUSP Recruiting
Sao Paulo, Brazil, 05403-010
Sub-Investigator: Monica Kayo, MD         
Sponsors and Collaborators
University of Sao Paulo

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Helio Elkis, University of Sao Paulo Identifier: NCT01016145    
Other Study ID Numbers: Projesq-IPAP
First Posted: November 19, 2009    Key Record Dates
Last Update Posted: November 19, 2009
Last Verified: November 2009
Keywords provided by University of Sao Paulo:
predictors of response
18-45 years old
Additional relevant MeSH terms:
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Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs