F31
Conditions
Interventions
Group 1: This is a monocentric, 6-month prospective observational study, in which all assessments will be conducted by staff of the University Hospital Dresden. The planned start of the study is 01.07
the end of the study is planned for mid-2027 (30.06.2027), or earlier should the recruitment target of n=30 be reached. Patients may either be in treatment directly at the Department of Psychiatry and
Sponsors
Uniklinikum Dresden
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: • Diagnosis of a bipolar disorder (type I or II), confirmed by a structured clinical interview (MINI) • Euthymia in the past 3 months (anamnestic, as well as current YMRS =12, MADRS =12) • Planned initiation (or re-initiation) of lithium treatment by the treating psychiatrist. For re-initiation, the lithium-free interval should be at least 6 months • Age: 18-50 years • Regular, daily smartphone usage • Capacity to provide informed consent
Exclusion criteria
Exclusion criteria: • Acute affective episode (MADRS > 12 or YMRS >12) requiring immediate treatment adjustment or inpatient treatment • Working in shift work (night shifts, rotating shifts, etc.) • Severe comorbid conditions: o Current substance dependence (e.g., consumption = 3 days/week) requiring detoxification o Serious physical illness (unstable cardiovascular disease, kidney disease, uncontrolled thyroid disorders, sleep apnea) that would have a significant influence on the circadian rhythm or lithium metabolism • Cognitive impairment: Lack of understanding of the study procedures, questionnaires or informed consent • Planned changes in psychotropic medication: Planned significant change (= 50% change in daily dose) in another psychotropic medication, e.g. antipsychotics, during study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lithium-response after (re)initiation 6 months after Lithium initiation LIFE questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Validation digital circadian rhythm (CR) metrics: correlation coefficients between smartphone-derived CR indices and actigraphy-derived CR-indices, e.g. intradaily Stability/Variability, Relative Amplitude, and validated CR-questionnaires at baseline (MEQ) 2. Correlation between smartphone-derived CR metrics and serum lithium levels and lithium dose over the course of the study 3. changes in sleep-EEG parameters pre-post Lithium initiation 4. Predictive utility of smartphone-derived CR metrics for functional outcomes (FAST) and quality of life measures (WHOQOL-BREF). | — |
Countries
Germany
Contacts
Public ContactVera Ludwig
Uniklikum Dresden
Outcome results
None listed