Nitraria Retusa Infusion for Clozapine-Related Metabolic Side Effects in Treatment-Resistant Schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study adds a 90-day daily infusion of dried Nitraria retusa leaves to participants’ usual clozapine-based treatment, with ongoing monitoring. It targets metabolic changes tied to clozapine, including obesity and abdominal obesity, in adults diagnosed with treatment-resistant schizophrenia. Evaluations occur at baseline, day 10, day 30, day 45, day 60, and day 90, with monthly CBCs to align with clozapine safety surveillance. The study is conducted at Farhat Hached University Hospital in Sousse, Tunisia, and follows a pre-experimental pilot design.

Why it matters

Who can join: the full rules

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

Where it's running

• Farhat Hached University Hospital
  Sousse, Tunisia Recruiting

Study contacts

• Study coordinator: Bochra Nourhène Saguem, M.D.; Associate Professor
• Email: saguem.bochra@gmail.com
• Phone: +21655617728

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.