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Bipolar DisorderNCT04454073

Investigation of Factors Associated With Preserved Cognitive Function in Bipolar Disorder

An observational study of Bipolar Disorder, run by St. Olavs Hospital at 1 site in Norway.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bipolar Disorder
How many people
87 participants
Where
1 siteNorway
Study dates
29 Oct 2021to 1 Jun 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Norway1 site

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

    Trondheim

Other trials in Norway

About this study

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.

Read the 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 ten days. At inclusion, the investigators will collect information on other psychiatric conditions, known somatic diseases, symptom levels of depression, and symptoms of hypo-/mania. Insomnia severity and risk factors for metabolic syndrome will be assessed. Secondly, the investigators will examine sleep and activity with both subjective and objective measures for ten days. 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 five years after enrolment.

Keywords
Cognition, Cross-sectional Studies
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04454073
Study groupRoleWhat they receive
Bipolar patientsIn euthymic state or with mild to moderate symptoms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: On day 7 after inclusion

  2. 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.

    Measured: Up to 5 years after inclusion

Secondary outcomes (15)

  1. Montgomery Åsberg Depression Rating Scale (MADRS)

    MADRS will be used to assess depressive symptoms. Range is 0-60. Higher score indicate more severe depressive symptoms.

    Measured: Day 1

  2. Young Mania Rating Scale (YMRS)

    YMRS will be used to assess hypo-/manic symptoms. Range is 0 to 60. Higher score indicate more severe manic symptoms.

    Measured: Day 1

  3. Insomnia Severity Index (ISI)

    A self-reported questionnaire of insomnia severity. Range is 08-28. Higher values represent higher levels of insomnia symptom severity.

    Measured: Day 1

  4. Medication use

    Daily doses and classes of medications (e.g. antipsychotics, mood stabilizers, benzodiazepines, etc.) prescribed per individual by the time of inclusion will be recorded.

    Measured: Day 1

  5. Actigraph

    Actigraph is a small device usually worn on the wrist that records the activity level of the body by sensing physical movement. The actigraph will be used to objectively assess sleep variables and daytime activity parameters.

    Measured: 1 week

  6. Sleep diary

    A self-reported record of the participants' sleeping and waking times.

    Measured: 1 week

  7. Oximetry

    Oximetry is a measurement of the blood's oxygen saturation. It will be used to assess any indication of sleep apnea for one night during the period of sleep assessment

    Measured: 1 day (1 night during period of sleep assessment)

  8. The Functioning Assessment Short Test (FAST)

    FAST will be used to assess functional outcomes. Range is 0-72. Higher values indicate greater disability

    Measured: 7 days after inclusion

  9. Cognitive complaints in Bipolar disorder Rating Assessment (COBRA)

    COBRA is an assessment of subjective cognitive dysfunction. Range is 0-48 and higher scores indicate more cognitive complaints.

    Measured: 7 days after inclusion

  10. The Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN)

    BRIAN is an assessment of circadian rhythms disturbance. Range is 1 to 72 and higher score indicate more severe disturbance of circadian rhythms.

    Measured: 7 days after inclusion

  11. Alcohol use disorders identification test (AUDIT)

    AUDIT is an assessment of the frequency and quantity of alcohol consumption where higher scores indicate higher levels of use.

    Measured: 7 days after inclusion

  12. Drug use disorders identification test (DUDIT)

    DUDIT is an assessment of the frequency and quantity of drug consumption where higher scores indicate higher levels of use.

    Measured: 7 days after inclusion

  13. Number of participants With Metabolic syndrome

    The World Health Organisation criteria for the metabolic syndrome will be used in the dichotomisation of the metabolic factors: Systolic blood pressure will be dichotomised as ≤ 140 mmHg or >140 mmHg and diastolic blood pressure as ≤ 90 mmHg or > 90 mmHg. Triglycerides will be classified as < 1.7 mmol/l or ≥ 1.7mmol/l. HDL cholesterol will be categorised as ≥ 1 mmol/l or <1 mmol/l for women and ≥ 0.90 mmol/l or <0.90 mmol/l for men. Fasting glucose will be defined as elevated when the plasma glucose levels is ≥7.0 mmol/l and two dichotomous groups will be created; < 7.0 mmol/l or ≥ 7.0 mmol/l. Waist circumference will be measured at the level of the umbilicus, and the hip girth will be measured at the level of maximal protrusion of the gluteal muscles. Waist-to-hip ratio will be dichotomised as ≤ 0.85 or > 0.85 for women and ≤ 0.90 or > 0.90 for men. The waist circumference will be categorised as ≤ 88 cm or > 0.88 for women and ≤ 102 cm or >102 cm for men.

    Measured: 7 days after inclusion

  14. Numbers of participants With disturbances of Thyroid function

    Normal thyroid function is considered thyroid stimulating hormone (TSH) levels in the range from 0.24 to 3.78 mIU/l and T4 levels in the range of 13.5 to 21.2 pmol/l.

    Latent and subclinical biochemical hypothyroidism; with an elevation of TSH with T4 in the normal range.

    Overt biochemical hypothyroidism: elevated TSH and a decrease of T4 levels. Biochemical hyperthyroidism and latent biochemical hyperthyroidism: TSH levels below the normal range with and without elevated T4.

    Measured: 7 days after inclusion

  15. Diagnostic evaluation With Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-5)

    This measure will be used to determine if participants meet the diagnostic criteria for Bipolar Disorder. This is a yes/no diagnostic tool and our data indicate percentage who meet criteria for bipolar type I or type II.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2020
  2. Study start29 Oct 2021
  3. Primary completion1 May 2024
  4. Study completion1 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04454073
Sponsor's protocol ID
67144
Status last verified
Jul 2026
First submitted
8 Jun 2020
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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. 2026 May;153(5):515-524. doi: 10.1111/acps.70031. Epub 2025 Aug 31.

    PubMed 40887748

Questions about this trial

What is this clinical trial studying?

An observational study of Bipolar Disorder, run by St. Olavs Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of cognitive function in bipolar patients (time frame: On day 7 after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04454073, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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