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Identifying Predictors of Response to Antipsychotics Using a Treatment Algorithm

Sponsor
University of Sao Paulo (Other)
Overall Status
Unknown status
CT.gov ID
NCT01016145
Collaborator
(none)
126
Enrollment
1
Location
2
Arms
15
Duration (Months)
8.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated 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 :
Apr 1, 2009
Anticipated Primary Completion Date :
Jun 1, 2010
Anticipated Study Completion Date :
Jul 1, 2010

Arms and Interventions

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 Names:
  • Seroquel, Geodon, Zyprexa, Abilify

    		•

    Outcome Measures

    Primary Outcome Measures

    1. % responders to first generation antipsychotics vs. % responders to second generation antipsychotics [8-12 weeks]

    Secondary Outcome Measures

    1. % of treatment abandon and respective causes [8-12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    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

    Locations

    Site City State Country Postal Code
    1 Instituto de Psiquiatria - Hospital das Clinicas FMUSP Sao Paulo Brazil 05403-010

    Sponsors and Collaborators

    • University of Sao Paulo

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01016145
    Other Study ID Numbers:
    • Projesq-IPAP
    First Posted:
    Nov 19, 2009
    Last Update Posted:
    Nov 19, 2009
    Last Verified:
    Nov 1, 2009
    Keywords provided by , ,
    Schizophrenia
    predictors of response
    antipsychotics
    18-45 years old
    non-refractory
    Additional relevant MeSH terms:
    Schizophrenia
    Psychotic Disorders
    Antipsychotic Agents

    Study Results

    No Results Posted as of Nov 19, 2009