Psychobiological Markers to Improve Diagnosis and to Predict Affective Episodes in Bipolar Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 主要终点
- Sleep onset
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
Sleep onset
时间窗: 12 weeks for study 1; 1 year for study 2
Smartwatch measure of sleep onset.
Motor activity
时间窗: 12 weeks for study 1; 1 year for study 2
Smartwatch data on number of steps each half time of the day
Learning rate
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 12 weeks for study 1; 1 year for study 2
We will administer foraging task and calculate a foraging exit threshold.
Sleep duration
时间窗: 12 weeks for study 1; 1 year for study 2
Smartwatch measure of sleep duration.
Sleep quality
时间窗: 12 weeks for study 1; 1 year for study 2
Smartwatch measure of sleep quality.
次要结局
- Questionnaire(12 weeks for study 1; 1 year for study 2)
- Questionnaires(12 weeks for study 1; 1 year for study 2)
研究者
Marc Guitart-Masip
Principal Investigator, Specialist in Psychiatry
Karolinska Institutet