Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07427966
Eligibility Criteria:
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 without psychiatric illness:
* Current or previous psychiatric diagnosis.
For patients with bipolar disorder and patients with recurrent depression:
* Patients who are in an active affective episode (mania, hypomania or depression) at the time of recruitment.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07427966
Study Brief:
Protocol Section:
NCT07427966