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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REPEC

Registry ID

PER-100-09

Enrollment

180

Registered

2009-12-17

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F20 NULL NULL

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

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).

Design outcomes

Primary

Measure	Time frame
Defined by the total score of the Positive and Negative Symptoms Scale (PANSS) (23) at week 6. NAME OF THE RESULT: Clinical outcome PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Week 6	—

Secondary

Measure	Time frame
Defined by the total score of the Positive and Negative Symptoms Scale (PANSS) (23) at week 6. NAME OF THE RESULT: Clinical outcome PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Week 6;Defined by: a) the respective score for general, positive and negative PASS symptoms at week 6 (day 43) and month 6 (day 180) of having started with the study regimen; b) the percentage of patients who achieve a reduction of 10%, 20% and 30% of the total initial PANSS score at week 6 and 6 months. NAME OF THE RESULT: General psychopathology, positive and negative psychotic symptoms PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: at week 6 and 6 months.;Score of the Global Clinical Impression scale at week 6 (day 43) and at 6 months (day 180) after starting the study regime. NAME OF THE RESULT: Variation of the Global Clinical Printing Scale Score PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: at week 6 (day 43) and at 6 months (day 180);Defined by: a) the overall AIMS score at week 6 (day 43) and at 6 months (day 180) after starting the study regime; b) the total score of the Barnes Akathisia Global Assessment at week 6 (day 43) and at 6 months (day 180) after starting the study regime; c) the total score of the Simpson Angus scale at week 6 (day 43) and at 6 months (day 180) after starting the study regime. NAME OF THE RESULT: Extra-pyramidal adverse effects PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 6 months;defined by: a) the total score of the symbol substitution test; and b) the total score of the test of union of numbers with 10 digits at week 6 (day 43) and at 6 months (day 180) of having started the study regime. NAME OF THE RESULT: Cognitive Deficits PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMAR	—

Measure

Time frame

Defined by the total score of the Positive and Negative Symptoms Scale (PANSS) (23) at week 6. NAME OF THE RESULT: Clinical outcome PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Week 6;Defined by: a) the respective score for general, positive and negative PASS symptoms at week 6 (day 43) and month 6 (day 180) of having started with the study regimen; b) the percentage of patients who achieve a reduction of 10%, 20% and 30% of the total initial PANSS score at week 6 and 6 months. NAME OF THE RESULT: General psychopathology, positive and negative psychotic symptoms PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: at week 6 and 6 months.;Score of the Global Clinical Impression scale at week 6 (day 43) and at 6 months (day 180) after starting the study regime. NAME OF THE RESULT: Variation of the Global Clinical Printing Scale Score PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: at week 6 (day 43) and at 6 months (day 180);Defined by: a) the overall AIMS score at week 6 (day 43) and at 6 months (day 180) after starting the study regime; b) the total score of the Barnes Akathisia Global Assessment at week 6 (day 43) and at 6 months (day 180) after starting the study regime; c) the total score of the Simpson Angus scale at week 6 (day 43) and at 6 months (day 180) after starting the study regime. NAME OF THE RESULT: Extra-pyramidal adverse effects PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 6 months;defined by: a) the total score of the symbol substitution test; and b) the total score of the test of union of numbers with 10 digits at week 6 (day 43) and at 6 months (day 180) of having started the study regime. NAME OF THE RESULT: Cognitive Deficits PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMAR

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Countries

Peru

Outcome results