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

Sponsor
Karolinska Institutet
Study ID
NCT07427966
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

First listed
Feb 23, 2026
Start date
Apr 30, 2026
Status verified
Oct 2025
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: Bipolar Patients
    150 Individuals with a diagnosis of bipolar disorder will participate in studies 1 and 2
  • Arm: 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.
  • Arm: Healthy control
    200 Individuals with no major psychiatric disorder will participate in study 1 only.

Primary Outcome Measure

Sleep onset [ Time Frame: 12 weeks for study 1; 1 year for study 2 ]

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