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Desert plant tested against Clozapine's weighty side effects

NCT ID NCT07817069

Symptom relief Sponsor: Faculty of Medicine, Sousse Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

People with treatment-resistant schizophrenia often take clozapine, a drug that can cause serious weight gain and metabolic problems. This pilot study tests whether a daily infusion made from the leaves of the Nitraria retusa plant can reduce those side effects. Thirty patients will drink the infusion every evening for 90 days while continuing their usual medications and lifestyle. Researchers will track changes in body weight, waist size, and blood markers of metabolic health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nitraria retusa leaf infusion, a plant-based dietary supplement
What this could lead to
If it works, this could offer a low-cost, plant-based way to ease the weight gain and metabolic problems that clozapine often causes, helping people stay on a treatment that controls their schizophrenia.
What could go wrong
This is a small, early pilot study with no control group, so any changes seen might be due to chance, diet, or other factors. The supplement's effects and safety in this population are not yet established.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

metabolic syndrome X Obesity obesity disorder Obesity, Abdominal Overweight Schizophrenia, Treatment-Resistant treatment-refractory schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Abdominal obesity Obesity & overweight Treatment resistant schizophrenia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Farhat Hached University Hospital

    RECRUITING

    Sousse, 4000, Tunisia

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