Observation of Clozapine Treatment Safety in Bipolar Disorder. (CloGD)

Medical University of Gdansk

Status: Invitation-only

Conditions: Bipolar Disorder

Treatments: Drug: Clozapine

Study type: Observational

Funder types: Other

Identifiers

NCT06011460

NKBBN/355-183/2023

Details and patient eligibility

About

The purpose of the registry is to record incidence of adverse events during treatment with clozapine in patients suffering from bipolar disorder.

Full description

Bipolar disorder, with its spectrum, remains a life-long and significant mental health concern due to its unpredictable nature and varied symptomatology. Despite the wide array of available treatments, some cases of bipolar disorder remain resistant to traditional medications. Clozapine, traditionally used for treatment-resistant schizophrenia, has shown promising results in managing resistant cases of bipolar disorder, particularly reducing the risk of suicide. There are not enough controlled studies on clozapine, especially in treatment resistant bipolar depression.

There are certain limitations associated with the use of clozapine, primarily related to the possibility of adverse events including agranulocytosis, myocarditis, pneumonia, intestinal obstruction and seizures. Therefore, there is a need for more studies on safety and tolerability of this treatment in patients with bipolar disorder.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of treatment-resistant depressive episode in the course of bipolar disorder according to DSM-5.
• Age from 18 to 65 years old.

Exclusion criteria

• Patients unable to give fully written informed consent
• Patients unable to comply with the requirements

Trial design

30 participants in 1 patient group

Patients' name

Description:

Diagnosis of treatment-resistant depressive episode in the course of bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders-5. Age from 18 to 65 years old.

Treatment:

Drug: Clozapine