Identifying Predictors of Response to Antipsychotics Using a Treatment Algorithm

NCT ID: NCT01016145

Last Updated: 2009-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia or Schizoaffective Disorder

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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First generation antipsychotic

Subjects randomized to this arm will receive treatment with haloperidol or chlorpromazine.

Group Type ACTIVE_COMPARATOR

Antipsychotics

Intervention Type DRUG

Haloperidol 2,5-10 mg; chlorpromazine 25-600 mg.

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

Group Type EXPERIMENTAL

Antipsychotics

Intervention Type DRUG

Quetiapine 25-800 mg; ziprasidone 80-160 mg; olanzapine 5-20mg; risperidone 2-8 mg; aripiprazole 15-30 mg

Interventions

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Antipsychotics

Quetiapine 25-800 mg; ziprasidone 80-160 mg; olanzapine 5-20mg; risperidone 2-8 mg; aripiprazole 15-30 mg

Intervention Type DRUG

Antipsychotics

Haloperidol 2,5-10 mg; chlorpromazine 25-600 mg.

Intervention Type DRUG

Other Intervention Names

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Seroquel, Geodon, Zyprexa, Abilify

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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University of Sao Paulo

Locations

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Instituto de Psiquiatria - Hospital das Clinicas FMUSP

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Monica Kayo, MD

Role: CONTACT

Phone: 551130696971

Email: [email protected]

Helio Elkis, PhD

Role: CONTACT

Phone: 551130696971

Email: [email protected]

References

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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.

Reference Type DERIVED
PMID: 23295604 (View on PubMed)

Other Identifiers

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Projesq-IPAP

Identifier Type: -

Identifier Source: org_study_id