Observation of Clozapine Treatment Safety in Bipolar Disorder.

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06011460

Acronym

CloGD

Enrollment

Registered

2023-08-25

Start date

2023-02-23

Completion date

2027-06-30

Last updated

2023-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Keywords

clozapine, bipolar disorder, suicidality, adverse events

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.

Interventions

DRUGClozapine

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.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026