Observation of Clozapine Treatment Safety in Bipolar Disorder. (CloGD)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT06011460 |
|
Recruitment Status :
Enrolling by invitation
First Posted : August 25, 2023
Last Update Posted : August 25, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment |
|---|---|
| Bipolar Disorder | Drug: Clozapine |
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 Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 30 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 1 Year |
| Official Title: | Observation of Clozapine Treatment Safety in Bipolar Disorder. |
| Actual Study Start Date : | February 23, 2023 |
| Estimated Primary Completion Date : | December 31, 2024 |
| Estimated Study Completion Date : | June 30, 2027 |
| Group/Cohort | 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. |
- Safety measures of clozapine treatment in patients with bipolar disorder. [ Time Frame: 1 year ]Incidence of possible occurrence of adverse events during treatment with clozapine in patients with bipolar disorder.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06011460
| Poland | |
| Department of Psychiatry, Medical University of Gdańsk | |
| Gdańsk, Pomorskie, Poland, 80-214 | |
| Principal Investigator: | Wiesław J Cubała, M.D. PhD | Medican University of Gdańsk |
| Responsible Party: | Medical University of Gdansk |
| ClinicalTrials.gov Identifier: | NCT06011460 |
| Other Study ID Numbers: |
NKBBN/355-183/2023 |
| First Posted: | August 25, 2023 Key Record Dates |
| Last Update Posted: | August 25, 2023 |
| Last Verified: | August 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
|
clozapine bipolar disorder suicidality adverse events |
|
Bipolar Disorder Bipolar and Related Disorders Mood Disorders Mental Disorders Clozapine Serotonin Antagonists Serotonin Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs GABA Antagonists GABA Agents |