NCT07427966

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Apr 2026

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Apr 2026Dec 2030

First Submitted

Initial submission to the registry

December 5, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

February 23, 2026

Status Verified

October 1, 2025

Enrollment Period

4.7 years

First QC Date

December 5, 2025

Last Update Submit

February 17, 2026

Conditions

Bipolar Disorder (BD)Major Depressive DisorderMood Disorders

Keywords

Mood disordersBipolar DisorderAffective disorder assesmentMajor depressive disorderCognitionSleepActivity

Outcome Measures

Primary Outcomes (9)

  • 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 Outcomes (7)

  • Questionnaire

    12 weeks for study 1; 1 year for study 2

  • Questionnaire

    12 weeks for study 1; 1 year for study 2

  • Questionnaire

    12 weeks for study 1; 1 year for study 2

  • Questionnaires

    12 weeks for study 1; 1 year for study 2

  • Questionnaire

    12 weeks for study 1; 1 year for study 2

  • +2 more secondary outcomes

Study Arms (3)

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depressive Disorder, MajorMood DisordersBipolar DisorderMotor Activity

Condition Hierarchy (Ancestors)

Depressive DisorderMental DisordersBipolar and Related DisordersBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Specialist in Psychiatry

Study Record Dates

First Submitted

December 5, 2025

First Posted

February 23, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

February 23, 2026

Record last verified: 2025-10