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

ConditionsTreatment Resistant Schizophrenia Obesity & Overweight Abdominal Obesity

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorFaculty of Medicine, Sousse

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

The Nitraria retusa arm
Dietary supplement
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).

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Treatment-resistant schizophrenia patients' with clozapine-induced obesityExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Body weight

Body weight, measured using a calibrated scale integrated into the bioelectrical impedance analyzer, with participants wearing light clothing.

Time frame