NCT07427966Not yet recruiting
Psychobiological Markers to Improve Diagnosis and to Predict Affective Episodes in Bipolar Disorder
Source: ClinicalTrials.gov · Last updated 23 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 5 Dec 2025
- Start date
- Apr 2026
- Primary completion date
- Dec 2030
- Lead sponsor
- Karolinska Institutet
- Diseases
- Depression, Bipolar disorder
- NCT number
- NCT07427966
What you commit to
- Study type: Observational
- Planned participants: 600
- From Apr 2026 to the primary completion date, Dec 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or previous psychiatric diagnosis.
- For patients with bipolar disorder and patients with recurrent depression:
Other illness
- Neurological disease or cognitive impairment that may affect study results or compliance with study procedures.
- Inability to understand and follow the study instructions (good knowledge of Swedish is required).
- For adults without psychiatric illness:
Other
- Common to all participants:
- Active substance abuse or dependence (alcohol or other substances).
- Inability to use a smartphone and smartwatch as required by the study.
- Inability to provide valid informed consent.
- Patients who are in an active affective episode (mania, hypomania or depression) at the time of recruitment.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.