NCT06011460

Observation of Clozapine Treatment Safety in Bipolar Disorder.

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Medical University of Gdansk · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	Clozapine	Diagnosis of treatment-resistant depressive episode in the course of bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Age from 18 to 65 years old.

Timeline

• Start date: 2023-02-23
• Primary completion: 2024-12-31
• Completion: 2027-06-30
• First posted: 2023-08-25
• Last updated: 2023-08-25

Locations

1 site across 1 country: Poland

Regulatory

• FDA-regulated drug study