Observation of Clozapine Treatment Safety in Bipolar Disorder.

Bipolar Disorder Clinical Trial

— CloGD  

Official title:

Observation of Clozapine Treatment Safety in Bipolar Disorder.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06011460
• Other study ID #: NKBBN/355-183/2023
• Status: Enrolling by invitation
• Start date: February 23, 2023
• Est. completion date: June 30, 2027

Study information

• Verified date: August 2023
• Source: Medical University of Gdansk
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: June 30, 2027
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

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.

Locations

Country	Name	City	State
Poland	Department of Psychiatry, Medical University of Gdansk	Gdansk	Pomorskie

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

References & Publications (4)

Delgado A, Velosa J, Zhang J, Dursun SM, Kapczinski F, de Azevedo Cardoso T. Clozapine in bipolar disorder: A systematic review and meta-analysis. J Psychiatr Res. 2020 Jun;125:21-27. doi: 10.1016/j.jpsychires.2020.02.026. Epub 2020 Feb 27. — View Citation

Wilkowska A, Cubala WJ. Clozapine As Transformative Treatment In Bipolar Patients. Neuropsychiatr Dis Treat. 2019 Oct 9;15:2901-2905. doi: 10.2147/NDT.S227196. eCollection 2019. — View Citation

Wilkowska A, Wiglusz MS, Cubala WJ. Clozapine in Treatment-Resistant Bipolar Disorder With Suicidality. Three Case Reports. Front Psychiatry. 2019 Jul 19;10:520. doi: 10.3389/fpsyt.2019.00520. eCollection 2019. — View Citation

Wilkowska A, Wiglusz MS, Cubala WJ. Clozapine: promising treatment for suicidality in bipolar disorder. Psychiatr Danub. 2019 Sep;31(Suppl 3):574-578. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measures of clozapine treatment in patients with bipolar disorder.	Incidence of possible occurrence of adverse events during treatment with clozapine in patients with bipolar disorder.	1 year