Clinical trial NCT04454073: Investigation of Factors Associated With Preserved Cognitive Function in Bipolar Disorder
Official title: Investigation of Factors Associated With Preserved Cognitive Function in Bipolar Disorder
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Bipolar Disorder
Keywords: Cognition
Cross-sectional Studies
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

Detailed 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.

Eligibility criteria: 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.

Exclusion Criteria:

* Symptom level above inclusion criteria will be put on a waiting list, and if informed consent is given, will be included when symptom level is reduced.
* No Norwegian fluency.

Primary outcomes:
measure: Assessment of cognitive function in bipolar patients
timeFrame: On day 7 after inclusion
measure: Assessing change of cognitive function in bipolar patients
timeFrame: Up to 5 years after inclusion
Secondary outcomes:
measure: Montgomery Åsberg Depression Rating Scale (MADRS)
timeFrame: Day 1
measure: Young Mania Rating Scale (YMRS)
timeFrame: Day 1
measure: Insomnia Severity Index (ISI)
timeFrame: Day 1
measure: Medication use
timeFrame: Day 1
measure: Actigraph
timeFrame: 1 week
measure: Sleep diary
timeFrame: 1 week
measure: Oximetry
timeFrame: 1 day (1 night during period of sleep assessment)
measure: The Functioning Assessment Short Test (FAST)
timeFrame: 7 days after inclusion
measure: Cognitive complaints in Bipolar disorder Rating Assessment (COBRA)
timeFrame: 7 days after inclusion
measure: The Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN)
timeFrame: 7 days after inclusion
measure: Alcohol use disorders identification test (AUDIT)
timeFrame: 7 days after inclusion
measure: Drug use disorders identification test (DUDIT)
timeFrame: 7 days after inclusion
measure: Number of participants With Metabolic syndrome
timeFrame: 7 days after inclusion
measure: Numbers of participants With disturbances of Thyroid function
timeFrame: 7 days after inclusion
measure: Diagnostic evaluation With Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-5)
timeFrame: Day 1
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Bipolar and sleep outpatient clinic, Department of Østmarka, Division of Mental Health Care
Study officials:
affiliation: St Olavs Hospital, Division of Mental Health Care
name: Vegard Vestvik
role: STUDY_DIRECTOR
affiliation: St Olavs Hospital, Division of Mental Health Care
name: Anne Engum, phd
role: PRINCIPAL_INVESTIGATOR
affiliation: St Olavs Hospital, Division of Mental Health Care
name: Knut Langsrud
role: STUDY_DIRECTOR
References: