Psychobiological Markers to Improve Diagnosis and to Predict Affective Episodes in Bipolar Disorder (NCT07427966) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Psychobiological Markers to Improve Diagnosis and to Predict Affective Episodes in Bipolar Disorder
600 participantsStarted 2026-04
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
For all participants:
* 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.
For patients with bipolar disorder
* 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.
* Patients must be euthymic (stable and free from affective episodes) at the time of inclusion.
* Consent for the research team to access relevant clinical data from patient records.
For patients with recurrent depression
* Confirmed diagnosis of recurrent depression according to ICD-10 after completion of an assessment at a psychiatric clinic in Region Stockholm.
* Patients must have been referred for diagnostic assessment with the question of bipolar disorder.
* Patients must be euthymic (stable and free from affective episodes) at the time of inclusion.
Exclusion Criteria:
Common to all participants:
* 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.
* Inability to understand and follow the study instructions (good knowledge of Swedish is required).
For adults witho…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sleep onset
Timeframe: 12 weeks for study 1; 1 year for study 2
2
Motor activity
Timeframe: 12 weeks for study 1; 1 year for study 2
3
Learning rate
Timeframe: 12 weeks for study 1; 1 year for study 2
4
Reward sensitivity
Timeframe: 12 weeks for study 1; 1 year for study 2
5
Motivational bias
Timeframe: 12 weeks for study 1; 1 year for study 2
6
Effort discounting
Timeframe: 12 weeks for study 1; 1 year for study 2
7
Foraging exit threshold
Timeframe: 12 weeks for study 1; 1 year for study 2