Investigation of Factors Associated With Preserved Cognitive Function in Bipolar Disorder

NCT04454073 | Active Not Recruiting

• 1 other identifier: 67144
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar Disorder

Keywords

Cognition; Cross-sectional Studies

Outcome Measures

Primary Outcomes (2)

• Assessment of cognitive function in bipolar patients

  Memoro is a self-administered web-based neuropsychological test platform. All tests include both written and auditory instructions. The Memoro will be used to assess objective cognitive function. It contains measures of learning, storing, recalling and recognizing visual and verbal information, pattern separation, and verbal memory span, verbal working memory, processing speed, reaction time and cognitive control. Time frame: After examination of sleep and activity for a period of up to two weeks. Results from the test will be converted to z-scores.

  On day 7 after inclusion

• Assessing change of cognitive function in bipolar patients

  Memoro is a self-administered web-based neuropsychological test platform. All tests include both written and auditory instructions. It contains measures of learning, storing, recalling and recognizing visual and verbal information, pattern separation, and verbal memory span, verbal working memory, processing speed, reaction time and cognitive control. The Memoro will be used to assess stability or change in objective cognitive function.

  Up to 5 years after inclusion

Secondary Outcomes (15)

• Montgomery Åsberg Depression Rating Scale (MADRS)

  Day 1

• Young Mania Rating Scale (YMRS)

  Day 1

• Insomnia Severity Index (ISI)

  Day 1

• Medication use

  Day 1

• Actigraph

  1 week

Study Arms (1)

Bipolar patients

In euthymic state or with mild to moderate symptoms

Eligibility Criteria

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

Study Population

Bipolar patients diagnosed with Bipolar disorder I or II, in euthymic state or with mild to moderate symptoms at time of assessment.

You may qualify if:

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

You may not qualify if:

• No Norwegian fluency.

Sponsors & Collaborators

• St. Olavs Hospital: lead

Study Sites (1)

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

Trondheim, Norway

Location

Related Publications (1)

• 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.

  PMID: 40887748 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Vegard Vestvik

  St Olavs Hospital, Division of Mental Health Care

  STUDY DIRECTOR

• Anne Engum, phd

  St Olavs Hospital, Division of Mental Health Care

  PRINCIPAL INVESTIGATOR

• Knut Langsrud

  St Olavs Hospital, Division of Mental Health Care

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: July 1, 2020
• Study Start: October 29, 2021
• Primary Completion: May 1, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 8, 2025

Record last verified: 2025-06

Locations

NO (1)