Major Depressive DisorderMoodCatcherNCT07427966
Psychobiological Markers to Improve Diagnosis and to Predict Affective Episodes in Bipolar Disorder
An observational study of Major Depressive Disorder and Mood Disorders, run by Karolinska Institutet.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Mood Disorders, Bipolar Disorder (BD)
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Dec 2030
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Healthy control comes from the Stockholm region general population. * Patients comes from different psychiatric clinics in the Stockholm region.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
About this study
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.
- Keywords
- Mood disorders, Bipolar Disorder, Affective disorder assesment, Major depressive disorder, Cognition, Sleep, Activity
- Medical subject headings
- Depressive Disorder, Major, Mood Disorders, Bipolar Disorder, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Sleep onset
Smartwatch measure of sleep onset.
Measured: 12 weeks for study 1; 1 year for study 2
Motor activity
Smartwatch data on number of steps each half time of the day
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks for study 1; 1 year for study 2
Foraging exit threshold
We will administer foraging task and calculate a foraging exit threshold.
Measured: 12 weeks for study 1; 1 year for study 2
Sleep duration
Smartwatch measure of sleep duration.
Measured: 12 weeks for study 1; 1 year for study 2
Sleep quality
Smartwatch measure of sleep quality.
Measured: 12 weeks for study 1; 1 year for study 2
Secondary outcomes (7)
Questionnaire
Karolinska Sleep Questionnaire (KSQ)
Measured: 12 weeks for study 1; 1 year for study 2
Questionnaire
Reduced Morningness-Eveningness Questionnaire
Measured: 12 weeks for study 1; 1 year for study 2
Questionnaire
Center for Epidemiologic Studies Depression Scale Revised (CESD-R)
Measured: 12 weeks for study 1; 1 year for study 2
Questionnaires
Altman Self-Rating Mania Scale (ASRM)
Measured: 12 weeks for study 1; 1 year for study 2
Questionnaire
Munich Chronotype Questionnaire (MCTQ)
Measured: 12 weeks for study 1; 1 year for study 2
Questionnaire
Insomnia Severity
Measured: 12 weeks for study 1; 1 year for study 2
Questionnaire
Patient Health Questionnaire-9 (PHQ-9)
Measured: 12 weeks for study 1; 1 year for study 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Guitart-Masip, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427966
- Sponsor's protocol ID
- 2024-03094
- Acronym
- MoodCatcher
- Status last verified
- Oct 2025
- First submitted
- 5 Dec 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychobiological Markers to Improve Diagnosis and to Predict Affective Episodes in Bipolar Disorder
- ClinicalTrials.gov ID
- NCT07427966
- Acronym / sponsor ID
- MoodCatcher / 2024-03094
- Keywords
- Mood disorders, Bipolar Disorder, Affective disorder assesment, Major depressive disorder, Cognition, Sleep, Activity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Healthy control comes from the Stockholm region general population. * Patients comes from different psychiatric clinics in the Stockholm region.
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sleep onset
Time frame: 12 weeks for study 1; 1 year for study 2
Smartwatch measure of sleep onset.
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
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.
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.
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.
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.
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.
Sleep duration
Time frame: 12 weeks for study 1; 1 year for study 2
Smartwatch measure of sleep duration.
Sleep quality
Time frame: 12 weeks for study 1; 1 year for study 2
Smartwatch measure of sleep quality.
7 secondary outcomes
Questionnaire
Time frame: 12 weeks for study 1; 1 year for study 2
Questionnaire
Time frame: 12 weeks for study 1; 1 year for study 2
Questionnaire
Time frame: 12 weeks for study 1; 1 year for study 2
Questionnaires
Time frame: 12 weeks for study 1; 1 year for study 2
Questionnaire
Time frame: 12 weeks for study 1; 1 year for study 2
Questionnaire
Time frame: 12 weeks for study 1; 1 year for study 2
Questionnaire
Time frame: 12 weeks for study 1; 1 year for study 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder and Mood Disorders, run by Karolinska Institutet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep onset (time frame: 12 weeks for study 1; 1 year for study 2). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.