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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01016145
Other study ID # Projesq-IPAP
Secondary ID
Status Recruiting
Phase Phase 4
First received November 18, 2009
Last updated November 18, 2009
Start date April 2009
Est. completion date July 2010

Study information

Verified date November 2009
Source University of Sao Paulo
Contact Monica Kayo, MD
Phone 551130696971
Email monica.kayo@usp.br
Is FDA regulated No
Health authority Brazil: National Health Surveillance Agency
Study type Interventional

Clinical 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. second generation antipsychotics. Participants will be randomized to one of the groups. Trial duration: 12 weeks.


Recruitment information / eligibility

Status Recruiting
Enrollment 126
Est. completion date July 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Antipsychotics
Quetiapine 25-800 mg; ziprasidone 80-160 mg; olanzapine 5-20mg; risperidone 2-8 mg; aripiprazole 15-30 mg
Antipsychotics
Haloperidol 2,5-10 mg; chlorpromazine 25-600 mg.

Locations

Country Name City State
Brazil Instituto de Psiquiatria - Hospital das Clinicas FMUSP Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary % responders to first generation antipsychotics vs. % responders to second generation antipsychotics 8-12 weeks No
Secondary % of treatment abandon and respective causes 8-12 weeks No
See also
  Status Clinical Trial Phase
Completed NCT02504476 - Multiple Ascending Dose Study on Safety, Tolerability, and Pharmacokinetics of AMG 581 in Healthy Subjects or Subjects With Schizophrenia or Schizoaffective Phase 1
Completed NCT02567370 - Single-ascending Dose Study With a Food-Effect Cohort to Evaluate AMG 581 Phase 1