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Effects of Nitraria Retusa Infusion on Clozapine-induced Metabolic Side Effects

RecruitingNAAges 18 Years - 65 YearsAllFaculty of Medicine, Sousse
NCT07817069 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The primary objective of the study is to assess the efficacy and tolerability of a 90-day daily supplementation with a Nitraria retusa dried crushed leaves infusion on the iatrogenic metabolic side effects induced in patients with treatment-resistant schizophrenia following clozapine treatment. After providing written informed consent, eligible patients with treatment-resistant schizophrenia will be invited to receive a daily Nitraria retusa extract infusion at approximately 9 PM for 90 consecutive days, as an adjunct to their usual medications. Patients will be instructed to maintain their usual diet, routine, and lifestyle throughout the study. Clinical and biological evaluations will be conducted prospectively at baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3). Two additional assessments will be planned at day 30 and day 60 to comply with the monthly complete blood count (C

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📋 Eligibility rules (as published)
Inclusion Criteria: * a diagnosis of treatment-resistant schizophrenia; * current treatment with clozapine monotherapy or clozapine combined with other psychotropics that have a minimal documented impact on body weight; - demonstration of a response to clozapine, defined as a reduction of at least 20% in the total score on the Positive and Negative Syndrome Scale (PANSS) or the Brief Psychiatric Rating Scale (BPRS) after 8-12 weeks of treatment at effective therapeutic doses; * presence of obesity (BMI \> 30 kg/m²) or central obesity (waist circumference \> 94 cm in men and \> 80 cm in women), which developed following clozapine introduction. * free informed written consent Exclusion Criteria: * concurrent use of clozapine with other psychotropic agents that have a documented moderate-to-high influence on body weight * current treatment with metformin * pregnancy or breastfeeding * non acceptance to take part to the study
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What it tests

  • The Nitraria retusa arm
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Where

1 site
Farhat Hached University Hospital
Sousse, Tunisia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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