A 6-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY OF ADJUNCTIVE TRIMETHOPRIM-SULFAMETHOXAZOLE IN FIRST EPISODE SCHIZOPHRENIA PATIENTS, SEROPOSITIVE TO TOXOPLASMA GONDII

Not Applicable

• Conditions: -F20; F20

• Registration Number: PER-100-09
• Lead Sponsor: IVERSIDAD PERUANA CAYETANO HEREDIA,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-17
• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

• Men or women between 18 and 60 years of age.
• Have a diagnosis of the first episode of psychosis with a duration of no more than 24 weeks at the time of screening and without prior antipsychotic treatment or with treatment with haloperidol or risperidone only in the 2 weeks before inclusion in the study.
• Positive serology for T. gondii (IgG or IgM).

Exclusion Criteria

• Active toxoplasmosis [Patients with ocular or systemic toxoplasmosis will be excluded from the protocol and referred to the relevant specialist]
• Treatment with any antibiotic or antiviral within 2 weeks prior to the day of inclusion.
• History of major depression, bipolar disorder or anxiety disorder according to DSM-IV criteria.
• History of diagnosis of abuse or dependence on psychoactive substances in the past 3 months according to the criteria of the DSM-IV.
• Presence of any clinically significant or unstable medical disorder.
• Suicidal ideation or serious suicidal risk.
• History or diagnosis of neurological diseases, including possible lesions that take up space in the brain.
• Abnormal liver or kidney profile.
• Folate deficiency.
• Serology positive for human immunodeficiency virus (HIV).
• History of allergic reactions or clinically significant adverse effects to the drug under study, excipients, or compounds closely related to the drugs used in this study.
• Subjects that are at high risk of not adhering to the study regimes or of being lost in the follow-up of the recruiters team (such as: people who do not live in Lima; presence of antisocial personality traits; person who attends alone to the institution, a person who comes to the institution with a person with whom he or she has problems, mainly legal).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Defined by the total score of the Positive and Negative Symptoms Scale (PANSS) (23) at week 6.<br>Measure:Clinical outcome<br>Timepoints:Week 6<br>