Identifying Predictors of Response to Antipsychotics Using a Treatment Algorithm

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by University of Sao Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01016145
First received: November 18, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • % of treatment abandon and respective causes [ Time Frame: 8-12 weeks ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01016145

Contacts
Contact: Monica Kayo, MD 551130696971 monica.kayo@usp.br
Contact: Helio Elkis, PhD 551130696971 helkis@usp.br

Locations
Brazil
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

No publications provided by University of Sao Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Helio Elkis, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01016145     History of Changes
Other Study ID Numbers: Projesq-IPAP
Study First Received: November 18, 2009
Last Updated: November 18, 2009
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by University of Sao Paulo:
Schizophrenia
predictors of response
antipsychotics
18-45 years old
non-refractory

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 15, 2014