Identifying Predictors of Response to Antipsychotics Using a Treatment Algorithm

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ClinicalTrials.gov 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

Sponsor:

Information provided by:

University of Sao Paulo

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
Schizophrenia or Schizoaffective Disorder	Drug: Antipsychotics	Phase 4

Study Design


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

Genetics Home Reference related topics: Schizoaffective disorder Schizophrenia

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

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 Name: Seroquel, Geodon, Zyprexa, Abilify

Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	All
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

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 ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Helio Elkis, University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT01016145 History of Changes
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:


Schizophrenia predictors of response antipsychotics 18-45 years old non-refractory

Additional relevant MeSH terms:


Schizophrenia Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Antipsychotic Agents Chlorpromazine Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs	Psychotropic Drugs Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

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