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NCT07817069

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

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)
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Record History

All 1 version: 1 with changes below.

  1. Study First Submitted

Endpoints

Primary

Body weight
Timeframe: baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3)
Waist circumference
Timeframe: baseline (T0), day 10 (T1), day 45 (T2), and day 90 (T3)

Secondary (8)

Other anthropometric measurements
Body composition
Concentration of Triglycerides
Concentration of High-Density Lipoprotein Cholesterol
Concentration of Low-Density Lipoprotein Cholesterol
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Fasting Blood Glucose Level
Glycated Hemoglobin (HbA1c) Level
Incidence of treatment-emergent abnormalities in Complete Blood Count, renal function, and hepatic Enzymes

Arms and interventions

Treatment-resistant schizophrenia patients' with clozapine-induced obesityExperimental

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 supplements: The Nitraria retusa arm

Sites

1 site in 1 country

  • Farhat Hached University HospitalSousse, Tunisia