Clinical trial NCT06011460: Observation of Clozapine Treatment Safety in Bipolar Disorder.
Official title: Observation of Clozapine Treatment Safety in Bipolar Disorder.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Bipolar Disorder
Keywords: clozapine
bipolar disorder
suicidality
adverse events
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with bipolar disorder treated with clozapine.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety measures of clozapine treatment in patients with bipolar disorder.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Department of Psychiatry, Medical University of Gdańsk
state: Pomorskie
Study officials:
affiliation: Medican University of Gdańsk
name: Wiesław J Cubała, M.D. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilkowska A, Wiglusz MS, Cubala WJ. Clozapine: promising treatment for suicidality in bipolar disorder. Psychiatr Danub. 2019 Sep;31(Suppl 3):574-578.
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.
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.
citation: 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.