Identifying Predictors of Response to Antipsychotics Using a Treatment Algorithm
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by University of Sao Paulo.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Sao Paulo
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01016145
First received: November 18, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Schizophrenia or Schizoaffective Disorder |
Drug: Antipsychotics |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Identifying Predictors of Response in 12 Weeks of Treatment With Antipsychotics Using a Treatment Algorithm for Schizophrenia |
Resource links provided by NLM:
MedlinePlus related topics:
Schizophrenia
Drug Information available for:
Quetiapine
Quetiapine fumarate
Ziprasidone hydrochloride
Aripiprazole
Olanzapine
Ziprasidone
Ziprasidone mesylate
Olanzapine pamoate
U.S. FDA Resources
Further study details as provided by University of Sao Paulo:
Primary Outcome Measures:
- % responders to first generation antipsychotics vs. % responders to second generation antipsychotics [ Time Frame: 8-12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- % of treatment abandon and respective causes [ Time Frame: 8-12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 126 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| Responsible Party: | Helio Elkis, University of Sao Paulo |
| ClinicalTrials.gov Identifier: | NCT01016145 History of Changes |
| Other Study ID Numbers: | Projesq-IPAP |
| Study First Received: | November 18, 2009 |
| Last Updated: | November 18, 2009 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Keywords provided by University of Sao Paulo:
|
Schizophrenia predictors of response antipsychotics 18-45 years old non-refractory |
Additional relevant MeSH terms:
|
Psychotic Disorders Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Antipsychotic Agents Tranquilizing Agents |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 22, 2013