Observation of Clozapine Treatment Safety in Bipolar Disorder.
NCT ID: NCT06011460
Last Updated: 2023-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
30 participants
OBSERVATIONAL
2023-02-23
2027-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients' name
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Age from 18 to 65 years old.
Exclusion Criteria
* Patients unable to comply with the requirements
18 Years
65 Years
ALL
No
Sponsors
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Medical University of Gdansk
OTHER
Responsible Party
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Principal Investigators
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Wiesław J Cubała, M.D. PhD
Role: PRINCIPAL_INVESTIGATOR
Medican University of Gdańsk
Locations
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Department of Psychiatry, Medical University of Gdańsk
Gdansk, Pomeranian Voivodeship, Poland
Countries
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References
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Wilkowska A, Wiglusz MS, Cubala WJ. Clozapine: promising treatment for suicidality in bipolar disorder. Psychiatr Danub. 2019 Sep;31(Suppl 3):574-578.
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.
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.
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.
Other Identifiers
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NKBBN/355-183/2023
Identifier Type: -
Identifier Source: org_study_id
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