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

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 Overview

• Status: Not yet recruiting
• Conditions: Mood Disorders; Major Depressive Disorder; Bipolar Disorder (BD)

• Study Type: Observational
• Enrollment (Estimated): 600

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

• Healthy control comes from the Stockholm region general population.
• Patients comes from different psychiatric clinics in the Stockholm region.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Bipolar Patients; 150 Individuals with a diagnosis of bipolar disorder will participate in studies 1 and 2
New Mood Disorder Patients; 250 patients from three affective clinics in the Stockholm Region (Northwest Psychiatry, North Stockholm Psychiatry, Southwest Psychiatry) who have been referred for assessment for bipolar disorder. Based on clinical experience, approximately 20% (approximately 50 patients) will ultimately be diagnosed with bipolar disorder, while the remaining 200 patients will retain their diagnosis of recurrent depression and be included as a comparison group in study 1 only. The 50 patients newly diagnosed with bipolar disorder will be included in studies 1 and 2.
Healthy control; 200 Individuals with no major psychiatric disorder will participate in study 1 only.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire	Karolinska Sleep Questionnaire (KSQ)	12 weeks for study 1; 1 year for study 2
Questionnaire	Reduced Morningness-Eveningness Questionnaire	12 weeks for study 1; 1 year for study 2
Questionnaire	Center for Epidemiologic Studies Depression Scale Revised (CESD-R)	12 weeks for study 1; 1 year for study 2
Questionnaires	Altman Self-Rating Mania Scale (ASRM)	12 weeks for study 1; 1 year for study 2
Questionnaire	Munich Chronotype Questionnaire (MCTQ)	12 weeks for study 1; 1 year for study 2
Questionnaire	Insomnia Severity	12 weeks for study 1; 1 year for study 2
Questionnaire	Patient Health Questionnaire-9 (PHQ-9)	12 weeks for study 1; 1 year for study 2

Collaborators and Investigators

• Sponsor: Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Bipolar Disorder; Sleep; Cognition; Activity; Major depressive disorder; Mood disorders; Affective disorder assesment
• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Mental Disorders; Depressive Disorder; Behavior; Bipolar Disorder; Mood Disorders; Depressive Disorder, Major; Motor Activity
• Other Study ID Numbers: 2024-03094

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No