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Identifying Predictors of Response to Antipsychotics Using a Treatment Algorithm

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2009 by University of Sao Paulo.
Recruitment status was:  Recruiting
Information provided by:
University of Sao Paulo Identifier:
First received: November 18, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
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 Intervention Phase
Schizophrenia or Schizoaffective Disorder Drug: Antipsychotics Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Identifying Predictors of Response in 12 Weeks of Treatment With Antipsychotics Using a Treatment Algorithm for Schizophrenia

Resource links provided by NLM:

Further study details as provided by University of Sao Paulo:

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

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

Estimated Enrollment: 126
Study Start Date: April 2009
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01016145

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

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
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Helio Elkis, University of Sao Paulo Identifier: NCT01016145     History of Changes
Other Study ID Numbers: Projesq-IPAP
Study First Received: November 18, 2009
Last Updated: November 18, 2009

Keywords provided by University of Sao Paulo:
predictors of response
18-45 years old

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on July 19, 2017