An interventional study of The Nitraria retusa arm in Treatment Resistant Schizophrenia, Obesity & Overweight and Abdominal Obesity, sponsored by Faculty of Medicine, Sousse. Recruiting at 1 site in Tunisia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Faculty of Medicine, Sousse · Not applicable, Interventional, and Treatment
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.
A pilot, pre-experimental study will be conducted.
Outcome variables Outcome measures were categorized as primary and secondary.
Primary outcomes included:
Secondary outcomes encompassed:
53 studies on the registry are indexed under Schizophrenia, Treatment-Resistant; 22 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 46 interventional studies indexed under Schizophrenia, Treatment-Resistant.
Browse Schizophrenia, Treatment-Resistant studies →Faculty of Medicine, Sousse is the lead sponsor of 23 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Inclusion criteria: (1) a diagnosis of treatment-resistant schizophrenia\]; (2) current treatment with clozapine monotherapy or clozapine combined with other psychotropics that have a minimal documented impact on body weight; (3) 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; and (4) 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. Non-inclusion criteria: (1) concurrent use of clozapine with other psychotropic agents that have a documented moderate-to-high influence on body weight; (2) current treatment with metformin; and (3) pregnancy or breastfeeding.
Dietary Supplement: The Nitraria retusa arm
A daily administration of Nitraria retusa extract infusion at approximately 9 PM for 90 consecutive days, as an adjunct to patients' usual medications, while maintaining usual diet, routine, and lifestyle throughout the study. Nitraria retusa was collected from saline soils in Kairouan (central Tunisia). The leaves were rinsed with water, air-dried in the shade at room temperature for 15 days, and crushed into a fine powder using a Moulinex grinder (MOULINEX SA, France). Nitraria retusa was supplied to participants in sachets containing 2,000 mg of powder. Participants were instructed to prepare the daily infusion by steeping 2,000 mg of the powder in 100 mL of boiled water for 15 minutes. Qualitative and quantitative analyses of the extract were performed using a validated high-performance liquid chromatography method (UHPLC-DAD, SHIMADZU 8045).
Body weight
Body weight, measured using a calibrated scale integrated into the bioelectrical impedance analyzer, with participants wearing light clothing.
Time frame: baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3)
Waist circumference
Waist circumference, measured at the narrowest point between the lower rib margin and the iliac crest, as an indicator of abdominal adiposity.
Time frame: baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3)
Other anthropometric measurements
Other anthropometric measurements including mid-upper arm circumference measured at the midpoint of the relaxed arm, and mid-thigh circumference measured at the midpoint of the thigh.
Time frame: baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3)
Body composition
Body composition, assessed via bioelectrical impedance analysis, including body fat percentage, muscle mass percentage, and body water percentage.
Time frame: baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3)
Concentration of Triglycerides
Fasting serum triglyceride (TG) concentration
Time frame: baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3)
Concentration of High-Density Lipoprotein Cholesterol
Fasting serum High-Density Lipoprotein Cholesterol (HDL-C) concentration
Time frame: baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3)
Concentration of Low-Density Lipoprotein Cholesterol
Fasting serum Low-Density Lipoprotein Cholesterol (LDL-C) concentration
Time frame: baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3)
Fasting Blood Glucose Level
Fasting plasma glucose concentration
Time frame: baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3)
Glycated Hemoglobin (HbA1c) Level
Percentage of glycated hemoglobin (HbA1c)
Time frame: baseline (T0) and day 90 (T3)
Incidence of treatment-emergent abnormalities in Complete Blood Count, renal function, and hepatic Enzymes
Number of participants with clinically significant treatment-emergent abnormalities in complete blood count (CBC), renal function markers, or hepatic enzymes during the 90-day intervention period.
Time frame: baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3)
Plan to share: Yes — The investigators plan to share anonymous results of the primary and secondary outcome variables of each study participant in form of Tables.
Supporting information: Clinical study report
Time frame: At the end of the trial
Started Jan 2026 (actual). Primary completion is estimated for Dec 2028, 35 months after the start.
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Faculty of Medicine, Sousse