Identifying Predictors of Response to Antipsychotics Using a Treatment Algorithm

NCT01016145 | Unknown Phase 4

• 1 other identifier: Projesq-IPAP
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia or Schizoaffective Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• % responders to first generation antipsychotics vs. % responders to second generation antipsychotics

  8-12 weeks

Secondary Outcomes (1)

• % of treatment abandon and respective causes

  8-12 weeks

Study Arms (2)

First generation antipsychotic

ACTIVE COMPARATOR

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

Drug: Antipsychotics

Second generation antipsychotics

EXPERIMENTAL

Subjects randomized to this arm will receive treatment with a second-generation antipsychotic: risperidone or olanzapine or aripiprazole or quetiapine or ziprasidone

Drug: Antipsychotics

Interventions

Antipsychotics DRUG

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

Also known as: Seroquel, Geodon, Zyprexa, Abilify

Second generation antipsychotics

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Schizophrenia or schizoaffective disorder
• Age: 18-45 years olde
• Less than 10 years of diagnosis
• Acute exacerbation of psychotic symptoms

You may not qualify if:

• Use of clozapine
• Clinical unstable disease
• Delirium and cognitive disorders

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Instituto de Psiquiatria - Hospital das Clinicas FMUSP

São Paulo, São Paulo, 05403-010, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 23295604 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Antipsychotic Agents; Quetiapine Fumarate; ziprasidone; Olanzapine; Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Psychotropic Drugs; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Piperazines; Heterocyclic Compounds, 1-Ring; Quinolones; Quinolines

Central Study Contacts

Monica Kayo, MD

CONTACT

551130696971; monica.kayo@usp.br

Helio Elkis, PhD

CONTACT

551130696971; helkis@usp.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 18, 2009
• First Posted: November 19, 2009
• Study Start: April 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: July 1, 2010
• Last Updated: November 19, 2009

Record last verified: 2009-11

Locations

BR (1)