Back to resultsIdentifying Predictors of Response to Antipsychotics Using a Treatment Algorithm
Primary Purpose
Schizophrenia or Schizoaffective Disorder
Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Antipsychotics
Antipsychotics
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia or Schizoaffective Disorder focused on measuring Schizophrenia, predictors of response, antipsychotics, 18-45 years old, non-refractory
Eligibility 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
Sites / Locations
- Instituto de Psiquiatria - Hospital das Clinicas FMUSPRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
First generation antipsychotic
Second generation antipsychotics
Arm Description
Subjects randomized to this arm will receive treatment with haloperidol or chlorpromazine.
Subjects randomized to this arm will receive treatment with a second-generation antipsychotic: risperidone or olanzapine or aripiprazole or quetiapine or ziprasidone
Outcomes
Primary Outcome Measures
% responders to first generation antipsychotics vs. % responders to second generation antipsychotics
Secondary Outcome Measures
% of treatment abandon and respective causes
Full Information
NCT ID
NCT01016145
First Posted
November 18, 2009
Last Updated
November 18, 2009
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01016145
Brief Title
Identifying Predictors of Response to Antipsychotics Using a Treatment Algorithm
Official Title
Identifying Predictors of Response in 12 Weeks of Treatment With Antipsychotics Using a Treatment Algorithm for Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
July 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia or Schizoaffective Disorder
Keywords
Schizophrenia, predictors of response, antipsychotics, 18-45 years old, non-refractory
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
First generation antipsychotic
Arm Type
Active Comparator
Arm Description
Subjects randomized to this arm will receive treatment with haloperidol or chlorpromazine.
Arm Title
Second generation antipsychotics
Arm Type
Experimental
Arm Description
Subjects randomized to this arm will receive treatment with a second-generation antipsychotic: risperidone or olanzapine or aripiprazole or quetiapine or ziprasidone
Intervention Type
Drug
Intervention Name(s)
Antipsychotics
Other Intervention Name(s)
Seroquel, Geodon, Zyprexa, Abilify
Intervention Description
Quetiapine 25-800 mg; ziprasidone 80-160 mg; olanzapine 5-20mg; risperidone 2-8 mg; aripiprazole 15-30 mg
Intervention Type
Drug
Intervention Name(s)
Antipsychotics
Intervention Description
Haloperidol 2,5-10 mg; chlorpromazine 25-600 mg.
Primary Outcome Measure Information:
Title
% responders to first generation antipsychotics vs. % responders to second generation antipsychotics
Time Frame
8-12 weeks
Secondary Outcome Measure Information:
Title
% of treatment abandon and respective causes
Time Frame
8-12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Kayo, MD
Phone
551130696971
Email
monica.kayo@usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Helio Elkis, PhD
Phone
551130696971
Email
helkis@usp.br
Facility Information:
Facility Name
Instituto de Psiquiatria - Hospital das Clinicas FMUSP
City
Sao Paulo
ZIP/Postal Code
05403-010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Kayo, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
23295604
Citation
Kayo M, Tassell I, Hiroce V, Menezes A, Elkis H. Does lack of improvement in the first two weeks predict treatment resistance in recent-onset psychosis? Clinics (Sao Paulo). 2012 Dec;67(12):1479-82. doi: 10.6061/clinics/2012(12)20. No abstract available.
Results Reference
derived
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Identifying Predictors of Response to Antipsychotics Using a Treatment Algorithm
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