Investigation of Factors Associated With Preserved Cognitive Function in

Status Recruiting

Clinical Trial Summary

Bipolar disorder (BD) ïs the fourth leading cause of disability worldwide among young people. Differences in demographic and clinical characteristics between patients do not influence educational achievement and receipt of disability pension, indicating that there are other factors such as neurocognitive function that are of importance for maintaining occupational and social function. Research has shown that at the group level, cognitive deficits are present in euthymic BD patients, while approximately 30%-50% of BD patients is not different from healthy controls when it comes to cognitive function. There is however little knowledge of risk and resilience factors for cognitive impairment in BD. Factors likely to contribute to cognitive and functional outcomes in BD, such as sleep, obesity, biological rhythms, comorbid medical and psychiatric conditions are also understudied. While it has been customary to focus research on factors related to the negative illness trajectories, the overarching aim of the current project is to explore factors associated with favourable outcomes. This shift in research focus is essential to elucidate factors related to more preserved function since this represents a clear gap in knowledge today.

Clinical Trial Description

This is an observational and prospective study aimed at identifying risk and resilience factors for cognitive impairment in BD. The investigators will enrol 85 participants with bipolar disorder. The assessment period is from one up to two weeks. At inclusion, the investigators will examine other psychiatric conditions, known somatic diseases and symptom levels of depression and hypo-/mania. Insomnia severity and risk factors for metabolic syndrome will also be assessed. Secondly, the investigators will examine sleep and Activity extensively with both subjective and objective measures for one to two weeks. Third, a newly developed web-based neuropsychological test protocol will be used shortly after assessment of sleep and activity to test cognitive function. Fourth, alcohol use, substance use and biological rhythms will be assessed. Lastly, the investigators will retest cognitive function and symptom levels up to five years after enrolment. ;

Study Design

Related Conditions & MeSH terms

Bipolar Disorder

Clinical Trial Details

NCT number	NCT04454073
Study type	Observational
Source	St. Olavs Hospital
Contact	Kristin Svee
Phone	+4795418907
Email	kristin.svee@stolav.no
Status	Recruiting
Phase
Start date	October 29, 2021
Completion date	May 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Investigation of Factors Associated With Preserved Cognitive Function in Bipolar Disorder

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms