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The purpose of the registry is to record incidence of adverse events during treatment with clozapine in patients suffering from bipolar disorder.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clozapine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with bipolar disorder treated with clozapine.
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| Name | Affiliation | Role |
|---|---|---|
| Wiesław J Cubała, M.D. PhD | Medican University of Gdańsk | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry, Medical University of Gdańsk | Gdansk | Pomeranian Voivodeship | 80-214 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31488793 | Background | Wilkowska A, Wiglusz MS, Cubala WJ. Clozapine: promising treatment for suicidality in bipolar disorder. Psychiatr Danub. 2019 Sep;31(Suppl 3):574-578. | |
| 31632038 | Background | 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. |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D013405 | Suicide |
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| ID | Term |
|---|---|
| D003024 | Clozapine |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| 31379632 | Background | 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. |
| 32182485 | Background | 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. |
| D016728 |
| Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |