Menu
Not yet recruiting NCT07427966

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

— Observational Major Depressive Disorder Mood Disorders Bipolar Disorder (BD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Major Depressive Disorder, Mood Disorders, Bipolar Disorder (BD). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Sleep onset [Time frame: 12 weeks for study 1; 1 year for study 2]
  • Motor activity [Time frame: 12 weeks for study 1; 1 year for study 2]
  • Learning rate [Time frame: 12 weeks for study 1; 1 year for study 2]
  • Reward sensitivity [Time frame: 12 weeks for study 1; 1 year for study 2]
  • Motivational bias [Time frame: 12 weeks for study 1; 1 year for study 2]
  • Effort discounting [Time frame: 12 weeks for study 1; 1 year for study 2]
  • Foraging exit threshold [Time frame: 12 weeks for study 1; 1 year for study 2]
  • Sleep duration [Time frame: 12 weeks for study 1; 1 year for study 2]
  • Sleep quality [Time frame: 12 weeks for study 1; 1 year for study 2]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07427966 · 2024-03094

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗