Observation of Clozapine Treatment Safety in Bipolar Disorder.

NCT06011460 | Enrolling By Invitation DMC FDA Drug

• 1 other identifier: NKBBN/355-183/2023
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the registry is to record incidence of adverse events during treatment with clozapine in patients suffering from bipolar disorder.

Conditions

Bipolar Disorder

Keywords

clozapine; bipolar disorder; suicidality; adverse events

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

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.

Patients' name

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with bipolar disorder treated with clozapine.

You may qualify if:

• Diagnosis of treatment-resistant depressive episode in the course of bipolar disorder according to DSM-5.
• Age from 18 to 65 years old.

You may not qualify if:

• Patients unable to give fully written informed consent
• Patients unable to comply with the requirements

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Department of Psychiatry, Medical University of Gdańsk

Gdansk, Pomeranian Voivodeship, 80-214, Poland

Location

Related Publications (4)

• Wilkowska A, Wiglusz MS, Cubala WJ. Clozapine: promising treatment for suicidality in bipolar disorder. Psychiatr Danub. 2019 Sep;31(Suppl 3):574-578.

  PMID: 31488793 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.

  PMID: 31632038 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.

  PMID: 31379632 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.

  PMID: 32182485 BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder; Suicidal Ideation

Interventions

Clozapine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Wiesław J Cubała, M.D. PhD

  Medican University of Gdańsk

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 25, 2023
• Study Start: February 23, 2023
• Primary Completion: December 31, 2024
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 25, 2023

Record last verified: 2023-08

Locations

PL (1)