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Enrolling by Invitation

NCT Number: NCT06011460

Observation of Clozapine Treatment Safety in Bipolar Disorder.

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

Enrolling by Invitation

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Key information

Conditions

Bipolar Disorder Behavior Behavioral Symptoms Bipolar and Related Disorders Mental Disorders Mood Disorders Self-Injurious Behavior Suicidal Ideation Suicide

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Psychiatry, Medical University of Gdańsk

Gdansk, Pomeranian Voivodeship, 80-214, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Medical University of Gdansk

Other

Registry information

Acronym: CloGD

Important dates

Study start
2023
Primary completion
2024
Study completion
2027
First posted
Aug 25, 2023
Registry last updated
Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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