In short
Clotiapine is an antipsychotic medicine that belongs to the dibenzothiazepine class. It is being studied in a Phase 3 clinical trial for schizophrenia, schizoaffective disorder, and schizophreniform disorder in people whose first-line treatment has failed. The trial includes 418 participants. Clotiapine is given by mouth as tablets.
This page explains what clotiapine is, how it works, and what the current clinical research says about its use in schizophrenia and related conditions.
Key points
- Clotiapine is an antipsychotic medicine studied for schizophrenia and related disorders.
- It is being tested in a Phase 3 randomised controlled trial.
- The trial includes 418 participants whose first-line schizophrenia treatment has failed.
- Clotiapine is taken by mouth as tablets.
- The trial measures symptom change using the PANSS total score after six weeks of treatment.
- The trial is currently authorised but not yet recruiting.
What is clotiapine?
Clotiapine is an antipsychotic medicine. It is also known by the names clothiapine, clotiapin, and entumine. Its chemical formula is C18H18ClN3S and its molecular weight is 343.87. In the United Kingdom, clotiapine is listed as a valid prescribable product in the form of 40 mg tablets for oral use. Clotiapine is classified under the ATC code N05AH06, which places it among antipsychotic medicines. It is not currently authorised through the European Medicines Agency as a centrally authorised medicine; the available information comes from national prescribing records and clinical trial registries.
How does clotiapine work?
Clotiapine belongs to the dibenzothiazepine class of antipsychotics. The available sources describe its chemical structure and its classification as a psychoactive substance, but they do not provide a detailed explanation of its molecular mechanism of action. As an antipsychotic, it is used to treat conditions involving psychosis, such as schizophrenia. The European Medicines Agency has listed clotiapine among antipsychotic active substances reviewed for safety concerns.
Which conditions is clotiapine used or studied for?
Clotiapine is being studied in a clinical trial for the following conditions:
- Schizophrenia — a long-term mental health condition that affects thinking, feelings, and behaviour.
- Schizoaffective disorder — a condition in which a person experiences both psychotic symptoms and mood disorder symptoms.
- Schizophreniform disorder — a condition with symptoms similar to schizophrenia but lasting a shorter period.
The trial focuses on people who have had a first-time treatment failure on their first-line treatment.
How is clotiapine given?
Clotiapine is given by mouth as oral tablets. The UK prescribing record lists clotiapine 40 mg tablets as a valid prescribable product for oral use. In the clinical trial, clotiapine is administered orally at a dose of 360 mg. A separate source lists oral doses of 80 mg for clotiapine.
What do the clinical trials show?
There is one registered clinical trial investigating clotiapine. It is a Phase 3 randomised controlled trial with 418 participants. The trial compares an early-intensified pharmacological treatment strategy against treatment as usual in people with schizophrenia, schizoaffective disorder, or schizophreniform disorder who have had a first-time treatment failure on their first-line treatment. Clotiapine is one of several antipsychotic medicines included in the intensified treatment arm.
The main measure in this trial is the change in symptom severity from baseline to six weeks, assessed using the Positive and Negative Syndrome Scale, known as the PANSS total score. The PANSS is a standard scale used to rate the severity of symptoms in schizophrenia. The trial status is authorised, meaning it has received approval but has not yet started recruiting participants.
What side effects are known?
The European Medicines Agency has reviewed the safety of antipsychotic medicines, including clotiapine, with regard to the risk of venous thromboembolism, which is the formation of blood clots in the veins. The review concluded that an association between antipsychotics and venous thromboembolism cannot be excluded. It was not possible to distinguish different risk levels between the various active substances. No other side effect information for clotiapine is available from the provided sources.