Psychobiological Markers to Improve Diagnosis and to Predict Affective Episodes in Bipolar Disorder
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorKarolinska Institutet
About this trial
This trial has two studies. In study 1, the investigators will explore the relationships between three psychobiological factors (sleep patterns, motor activity, and decision-making ability). The investigators aim to investigate how these factors interact in BD patients. This understanding will facilitate the distinction of BD patients from patients with recurrent depressive disorder (MDD) and healthy controls.
In study 2, the investigators will continue following patients with bipolar disorder and use the interplay between the three psychobiological factors to develop early markers of full-blown affective episodes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participants must be capable of giving informed consent.
Participants must be able to understand and follow the instructions in the project.
Access to a smartphone and ability to use a smartphone and actimeter.
Confirmed diagnosis of bipolar disorder (type 1 or type 2) according to ICD-10 after completion of an assessment at a psychiatric clinic in the Stockholm Region.
Disqualifiers
Active substance abuse or dependence (alcohol or other substances).
Neurological disease or cognitive impairment that may affect study results or compliance with study procedures.
Inability to use a smartphone and smartwatch as required by the study.
Inability to provide valid informed consent.
Trial population
* Healthy control comes from the Stockholm region general population. * Patients comes from different psychiatric clinics in the Stockholm region.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
600 Participants
are grouped into 3 trial groupsGroup A: Bipolar Patients
Group B: New Mood Disorder Patients
Group C: Healthy control
Trial outcomes
Primary outcomes
1
Sleep onset
Smartwatch measure of sleep onset.
Time frame
12 weeks for study 1; 1 year for study 22
Motor activity
Smartwatch data on number of steps each half time of the day
Time frame
12 weeks for study 1; 1 year for study 23
Learning rate
We will administer a reward learning task and use computational modeling to extract a learning rate.
Time frame
12 weeks for study 1; 1 year for study 24
Reward sensitivity
We will administer a valence go/no go task and use computational model to extract reward sensitivity.
Time frame
12 weeks for study 1; 1 year for study 2Secondary outcomes
1
Questionnaire
Karolinska Sleep Questionnaire (KSQ)
Time frame
12 weeks for study 1; 1 year for study 22
Questionnaire
Reduced Morningness-Eveningness Questionnaire
Time frame
12 weeks for study 1; 1 year for study 23
Questionnaire
Center for Epidemiologic Studies Depression Scale Revised (CESD-R)
Time frame
12 weeks for study 1; 1 year for study 24
Questionnaires
Altman Self-Rating Mania Scale (ASRM)
Time frame
12 weeks for study 1; 1 year for study 2Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: