Investigation of Factors Associated With Preserved Cognitive Function in Bipolar Disorder

NCT ID: NCT04454073

Last Updated: 2025-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

87 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-29

Study Completion Date

2026-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bipolar Disorder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Bipolar patients

In euthymic state or with mild to moderate symptoms

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Individuals aged \>=18 years who score \<= 16 on the MADRS or \<= 8 on the YMRS.
* Willing and able to give online informed consent.

* No Norwegian fluency.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vegard Vestvik

Role: STUDY_DIRECTOR

St Olavs Hospital, Division of Mental Health Care

Anne Engum, phd

Role: PRINCIPAL_INVESTIGATOR

St Olavs Hospital, Division of Mental Health Care

Knut Langsrud

Role: STUDY_DIRECTOR

St Olavs Hospital, Division of Mental Health Care

Locations

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Bipolar and sleep outpatient clinic, Department of Østmarka, Division of Mental Health Care

Trondheim, , Norway

Site Status

Countries

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Norway

References

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Svee K, Morken G, Hansen TI, Engum A. Internet-Based Cognitive Assessments During Remission in Bipolar Disorder: Subjective Cognitive Function and Clinical Severity. Acta Psychiatr Scand. 2025 Aug 31. doi: 10.1111/acps.70031. Online ahead of print.

Reference Type DERIVED
PMID: 40887748 (View on PubMed)

Other Identifiers

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67144

Identifier Type: -

Identifier Source: org_study_id

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