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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07427966

Acronym

MoodCatcher

Enrollment

600

Registered

2026-02-23

Start date

2026-04-01

Completion date

2030-12-01

Last updated

2026-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder (BD), Major Depressive Disorder, Mood Disorders

Keywords

Mood disorders, Bipolar Disorder, Affective disorder assesment, Major depressive disorder, Cognition, Sleep, Activity

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Sleep duration	12 weeks for study 1; 1 year for study 2	Smartwatch measure of sleep duration.
Effort discounting	12 weeks for study 1; 1 year for study 2	We will administer an effort discounting task and use computational modeling to extract an effort discounting parameter.
Foraging exit threshold	12 weeks for study 1; 1 year for study 2	We will administer foraging task and calculate a foraging exit threshold.
Sleep quality	12 weeks for study 1; 1 year for study 2	Smartwatch measure of sleep quality.
Sleep onset	12 weeks for study 1; 1 year for study 2	Smartwatch measure of sleep onset.
Motor activity	12 weeks for study 1; 1 year for study 2	Smartwatch data on number of steps each half time of the day
Learning rate	12 weeks for study 1; 1 year for study 2	We will administer a reward learning task and use computational modeling to extract a learning rate.
Reward sensitivity	12 weeks for study 1; 1 year for study 2	We will administer a valence go/no go task and use computational model to extract reward sensitivity.
Motivational bias	12 weeks for study 1; 1 year for study 2	We will administer a valence go/no go task and use computational model to extract a motivational bias.

Secondary

Measure	Time frame	Description
Questionnaires	12 weeks for study 1; 1 year for study 2	Altman Self-Rating Mania Scale (ASRM)
Questionnaire	12 weeks for study 1; 1 year for study 2	Karolinska Sleep Questionnaire (KSQ)

Outcome results