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NCT Number: NCT07427966

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Sleep onset

    Time frame: 12 weeks for study 1; 1 year for study 2

    Smartwatch measure of sleep onset.

  2. Motor activity

    Time frame: 12 weeks for study 1; 1 year for study 2

    Smartwatch data on number of steps each half time of the day

  3. Learning rate

    Time frame: 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.

  4. Reward sensitivity

    Time frame: 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.

  5. Motivational bias

    Time frame: 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.

  6. Effort discounting

    Time frame: 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.

  7. Foraging exit threshold

    Time frame: 12 weeks for study 1; 1 year for study 2

    We will administer foraging task and calculate a foraging exit threshold.

  8. Sleep duration

    Time frame: 12 weeks for study 1; 1 year for study 2

    Smartwatch measure of sleep duration.

  9. Sleep quality

    Time frame: 12 weeks for study 1; 1 year for study 2

    Smartwatch measure of sleep quality.

Secondary outcomes

  1. Questionnaire

    Time frame: 12 weeks for study 1; 1 year for study 2

    Karolinska Sleep Questionnaire (KSQ)

  2. Questionnaire

    Time frame: 12 weeks for study 1; 1 year for study 2

    Reduced Morningness-Eveningness Questionnaire

  3. Questionnaire

    Time frame: 12 weeks for study 1; 1 year for study 2

    Center for Epidemiologic Studies Depression Scale Revised (CESD-R)

  4. Questionnaires

    Time frame: 12 weeks for study 1; 1 year for study 2

    Altman Self-Rating Mania Scale (ASRM)

  5. Questionnaire

    Time frame: 12 weeks for study 1; 1 year for study 2

    Munich Chronotype Questionnaire (MCTQ)

  6. Questionnaire

    Time frame: 12 weeks for study 1; 1 year for study 2

    Insomnia Severity

  7. Questionnaire

    Time frame: 12 weeks for study 1; 1 year for study 2

    Patient Health Questionnaire-9 (PHQ-9)

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Acronym: MoodCatcher

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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