- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04454073
Investigation of Factors Associated With Preserved Cognitive Function in Bipolar Disorder
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Kristin Svee
- Phone Number: +4795418907
- Email: kristin.svee@stolav.no
Study Contact Backup
- Name: Anne Engum, phd
Study Locations
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Trondheim, Norway
- Recruiting
- Bipolar and sleep outpatient clinic, Department of Østmarka, Division of Mental Health Care
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Contact:
- Kristin Svee
- Email: kristin.svee@stolav.no
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Bipolar patients
In euthymic state or with mild to moderate symptoms
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Assessment of cognitive function in bipolar patients
Time Frame: On day 7 after inclusion
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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.
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On day 7 after inclusion
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Assessing change of cognitive function in bipolar patients
Time Frame: Up to 5 years after inclusion
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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.
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Up to 5 years after inclusion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Montgomery Åsberg Depression Rating Scale (MADRS)
Time Frame: Day 1
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MADRS will be used to assess depressive symptoms.
Range is 0-60.
Higher score indicate more severe depressive symptoms.
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Day 1
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Young Mania Rating Scale (YMRS)
Time Frame: Day 1
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YMRS will be used to assess hypo-/manic symptoms.
Range is 0 to 60. Higher score indicate more severe manic symptoms.
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Day 1
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Insomnia Severity Index (ISI)
Time Frame: Day 1
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A self-reported questionnaire of insomnia severity.
Range is 08-28.
Higher values represent higher levels of insomnia symptom severity.
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Day 1
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Medication use
Time Frame: Day 1
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Daily doses and classes of medications (e.g.
antipsychotics, mood stabilizers, benzodiazepines, etc.) prescribed per individual by the time of inclusion will be recorded.
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Day 1
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Actigraph
Time Frame: 1 week
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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.
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1 week
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Sleep diary
Time Frame: 1 week
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A self-reported record of the participants' sleeping and waking times.
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1 week
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Oximetry
Time Frame: 1 day (1 night during period of sleep assessment)
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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
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1 day (1 night during period of sleep assessment)
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The Functioning Assessment Short Test (FAST)
Time Frame: 7 days after inclusion
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FAST will be used to assess functional outcomes.
Range is 0-72.
Higher values indicate greater disability
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7 days after inclusion
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Cognitive complaints in Bipolar disorder Rating Assessment (COBRA)
Time Frame: 7 days after inclusion
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COBRA is an assessment of subjective cognitive dysfunction.
Range is 0-48 and higher scores indicate more cognitive complaints.
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7 days after inclusion
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The Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN)
Time Frame: 7 days after inclusion
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BRIAN is an assessment of circadian rhythms disturbance.
Range is 1 to 72 and higher score indicate more severe disturbance of circadian rhythms.
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7 days after inclusion
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Alcohol use disorders identification test (AUDIT)
Time Frame: 7 days after inclusion
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AUDIT is an assessment of the frequency and quantity of alcohol consumption where higher scores indicate higher levels of use.
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7 days after inclusion
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Drug use disorders identification test (DUDIT)
Time Frame: 7 days after inclusion
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DUDIT is an assessment of the frequency and quantity of drug consumption where higher scores indicate higher levels of use.
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7 days after inclusion
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Number of participants With Metabolic syndrome
Time Frame: 7 days after inclusion
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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.
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7 days after inclusion
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Numbers of participants With disturbances of Thyroid function
Time Frame: 7 days after inclusion
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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. |
7 days after inclusion
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Diagnostic evaluation With Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-5)
Time Frame: Day 1
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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.
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Day 1
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne Engum, phd, St Olavs Hospital, Division of Mental Health Care
- Study Director: Knut Langsrud, St Olavs Hospital, Division of Mental Health Care
- Study Director: Vegard Vestvik, St Olavs Hospital, Division of Mental Health Care
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 67144
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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