Schizophrenia or Schizoaffective DisorderPhase 4NCT01016145
Identifying Predictors of Response to Antipsychotics Using a Treatment Algorithm
A Phase 4 study testing Antipsychotics in people with Schizophrenia or Schizoaffective Disorder, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Schizophrenia or Schizoaffective Disorder
- What is being tested?
- Antipsychotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2009to Jul 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Schizophrenia or schizoaffective disorder
- Age: 18-45 years olde
- Less than 10 years of diagnosis
- Acute exacerbation of psychotic symptoms
Who cannot join
- Use of clozapine
- Clinical unstable disease
- Delirium and cognitive disorders
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto de Psiquiatria - Hospital das Clinicas FMUSP
São Paulo, São Paulo, 05403-010
Monica Kayo, MD
About this study
Official title: Identifying Predictors of Response in 12 Weeks of Treatment With Antipsychotics Using a Treatment Algorithm for Schizophrenia
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.
- Being tested
- Antipsychotics
- Keywords
- Schizophrenia, predictors of response, antipsychotics, 18-45 years old, non-refractory
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntipsychoticsDrug
Also called Seroquel, Geodon, Zyprexa, Abilify
Quetiapine 25-800 mg; ziprasidone 80-160 mg; olanzapine 5-20mg; risperidone 2-8 mg; aripiprazole 15-30 mg
AntipsychoticsDrug
Haloperidol 2,5-10 mg; chlorpromazine 25-600 mg.
| Study group | Role | What they receive |
|---|---|---|
| First generation antipsychotic | Active comparator | Subjects randomized to this arm will receive treatment with haloperidol or chlorpromazine. Receives: 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 Receives: Drug: Antipsychotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
% responders to first generation antipsychotics vs. % responders to second generation antipsychotics
Measured: 8-12 weeks
Secondary outcomes (1)
% of treatment abandon and respective causes
Measured: 8-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2010 (estimated)
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia or Schizoaffective DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016145
- Sponsor's protocol ID
- Projesq-IPAP
- Status last verified
- Nov 2009
- First submitted
- 18 Nov 2009
- Last updated
- 19 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23295604
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Predictors of Response in 12 Weeks of Treatment With Antipsychotics Using a Treatment Algorithm for Schizophrenia
- ClinicalTrials.gov ID
- NCT01016145
- Acronym / sponsor ID
- Projesq-IPAP
- Keywords
- Schizophrenia, predictors of response, antipsychotics, 18-45 years old, non-refractory
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 19 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First generation antipsychotic | Active comparator | Drug: AntipsychoticsSubjects randomized to this arm will receive treatment with haloperidol or chlorpromazine. |
| Second generation antipsychotics | Experimental | Drug: AntipsychoticsSubjects randomized to this arm will receive treatment with a second-generation antipsychotic: risperidone or olanzapine or aripiprazole or quetiapine or ziprasidone |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Schizophrenia or schizoaffective disorder
- Age: 18-45 years olde
- Less than 10 years of diagnosis
- Acute exacerbation of psychotic symptoms
Key exclusion criteria (3 listed)
- Use of clozapine
- Clinical unstable disease
- Delirium and cognitive disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntipsychoticsAlso: Seroquel, Geodon, Zyprexa, AbilifyQuetiapine 25-800 mg; ziprasidone 80-160 mg; olanzapine 5-20mg; risperidone 2-8 mg; aripiprazole 15-30 mg | Drug | Second generation antipsychotics |
| AntipsychoticsHaloperidol 2,5-10 mg; chlorpromazine 25-600 mg. | Drug | First generation antipsychotic |
Primary outcome
% responders to first generation antipsychotics vs. % responders to second generation antipsychotics
Time frame: 8-12 weeks
1 secondary outcome
% of treatment abandon and respective causes
Time frame: 8-12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2009.
- Derived from this study: PubMed 23295604Kayo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antipsychotics in people with Schizophrenia or Schizoaffective Disorder, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monica Kayo, MD (551130696971, monica.kayo@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% responders to first generation antipsychotics vs. % responders to second generation antipsychotics (time frame: 8-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01016145, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2009.