The Efficacy of L-Carnitine in the Management of Acute Clozapine Intoxication

What Was Tested

This registered phase 2 trial tested L-Carnitine.

Clozapine is a dibenzodiazepine that is used atypical antipsychotic drug.

L-Carnitine (4-N-trimethylammonium-3-hydroxybutyric acid) is an endogenous mitochondrial membrane compound that is essential for the normal functions of mitochondria.

It had two arms (groups): Conventional Group (no intervention) and L-Carnitine Group (experimental).

This group will comprise 20 patients who will receive conventional supportive care (same as group 1), in addition to IV L-carnitine.

The registry classes the interventions as dietary supplement.

More on the Plan

Study design: Clinical controlled randomized clinical trial (phase II) will be conducted in Poison Center.

Who Took Part

The registry lists 40 planned participants were the target.

It was open to people of any sex.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: The study will include patients with moderate and severe acute clozapine poisoning. The patient's condition will be assessed on admission using a Poisoning Severity Score.

The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: when the diagnosis of acute clozapine poisoning is unconfirmed; patients that ingest other drugs other than clozapine; patients who presented late to the poison center (\>24 hr) following clozapine intake.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the L-Carnitine group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when L-Carnitine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2023-06 with completion listed for 2024-06.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mortality (time frame: up to 14 days). Neurotoxicity (time frame: up to 14 days). Cardiotoxicity (time frame: up to 14 days).

It also tracked 2 secondary outcomes, for example Intensive care unit admission and Duration of hospital stay.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of L-Carnitine in 40 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.