NCT07817069Recruiting
Effects of Nitraria Retusa Infusion on Clozapine-induced Metabolic Side Effects
Efficacy of Nitraria Retusa Infusion in Significantly Reducing Clozapine-induced Metabolic Side Effects in Patients With Treatment-resistant Schizophrenia: A Pre-Experimental Pilot Study
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
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 (CBC) surveillance recommended for patients receiving clozapine. Assessments include anthropometric measures, body composition, vital signs, CBC, metabolic panels, and renal and hepatic function. All biological samples were collected after a 12-hour fast.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 3 Sept 2026
- Start date
- 3 Jan 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- Faculty of Medicine, Sousse
- Diseases
- Schizophrenia, Obesity
- NCT number
- NCT07817069
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 3 Jan 2026 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- concurrent use of clozapine with other psychotropic agents that have a documented moderate-to-high influence on body weight
- current treatment with metformin
Other
- pregnancy or breastfeeding
- non acceptance to take part to the study
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Farhat Hached University Hospital Coordinator of this site? Confirm its status | Sousse | Tunisia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.