CloGD: Observation of Clozapine Treatment Safety in Bipolar Disorder.
Study Details
Study Description
Brief Summary
The purpose of the registry is to record incidence of adverse events during treatment with clozapine in patients suffering from bipolar disorder.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
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.
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Psychiatry, Medical University of Gdańsk | Gdańsk | Pomorskie | Poland | 80-214 |
Sponsors and Collaborators
- Medical University of Gdansk
Investigators
- Principal Investigator: Wiesław J Cubała, M.D. PhD, Medican University of Gdańsk
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- Wilkowska A, Wiglusz MS, Cubala WJ. Clozapine: promising treatment for suicidality in bipolar disorder. Psychiatr Danub. 2019 Sep;31(Suppl 3):574-578.
- NKBBN/355-183/2023