NCT07817069
Effects of Nitraria Retusa Infusion on Clozapine-induced Metabolic Side Effects
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Record History
All 1 version: 1 with changes below.
- Study First Submitted
Endpoints
Primary
Secondary (8)
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Arms and interventions
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