Observation of Clozapine Treatment Safety in Bipolar Disorder.

• Conditions: Bipolar Disorder
• Interventions: Drug: Clozapine

• Registration Number: NCT06011460
• Lead Sponsor: Medical University of Gdansk

Brief 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.

Study Timeline

• Study Start: 2023-02-23
• Status Verified: 2023-08
• Study First Submitted: 2023-08-21
• Study First Submitted QC: 2023-08-21
• Last Update Submitted: 2023-08-21
• Study First Posted: 2023-08-25
• Last Update Posted: 2023-08-25
• Primary Completion: 2024-12-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients' name	Clozapine	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.

Primary Outcome Measures

Name	Time	Method
Safety measures of clozapine treatment in patients with bipolar disorder.	1 year	Incidence of possible occurrence of adverse events during treatment with clozapine in patients with bipolar disorder.

Trial Locations

Locations (1)

Department of Psychiatry, Medical University of Gdańsk; 🇵🇱 Gdańsk, Pomorskie, Poland