Psychobiological Markers to Improve Diagnosis and to Predict Affective Episodes in Bipolar Disorder

N/ANot Yet RecruitingNCT07427966

Karolinska Institutet600 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Major Depressive Disorder Mood Disorders Bipolar Disorder (BD)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.