F32 F31 F33 F25
Conditions
Interventions
Group 1: The LUNA-study is a prospective study with longitudinal data collection. The sample consists of outpatients who are already receiving or will soon receive the drug lithium. Approximately 4-10
Sponsors
Charité - Universitätsmedizin Berlin, Klinik für Psychiatrie und Psychotherapie (CCM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Existing or planned lithium therapy in outpatient treatment for bipolar disorder (I and II), unipolar depression or schizoaffective disorder
Exclusion criteria
Exclusion criteria: - Diagnosis of an antisocial or other severe personality disorder, paranoid schizophrenia, which makes a participation in the study impossible due to cognitive impairments. - Severe cognitive impairments, e.g. dementia or severe intellectual disability, withdrawal of informed consent - Institutionalisation by court or official order (according to AMG § 40 (1( 4))
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proof of concept of various measurement methods that can be used to reliably and validly measure the concentration of lithium, sodium, potassium and creatinine in saliva, capillary blood and dried blood spots of whole blood. | — |
Secondary
| Measure | Time frame |
|---|---|
| Suitable sample material (saliva, capillary blood, serum blood and dried blood spots of whole blood) for valid measurement of lithium, sodium, potassium and creatinine concentrations in comparison to blood serum concentrations is to be identified. In addition, explorative genetic analyses are carried out. Furthermore the influence of potential covariates, including comedication, tobacco use and comorbidities such as diabetes, on the correlation of analyte concentrations will be investigated. The aim is also to determine the participants' preferences with regard to sampling. Not validated questions in the baseline survey: recording of age, gender, number of depressive and (hypo-)manic episodes, age at first manifestation of depression and (hypo-)mania, duration and onset of depressive and (hypo-)manic episodes, current presence of a depressive or (hypo-)manic episode, thoughts of tiredness of life, suicide attempts in the past. Not validated questions on sample collection and preference (medium: serum blood, capillary blood, saliva, dried blood spots), preference for measurement at home or by the treating physicians, financing of a measuring device, preferred operation of a measuring device, preferred display of the lithium level/value, storage, alarm function, portability/size and handling of the measuring device. Not validated questions at each visit: lithium dose, dose of other medications, drinking, sleeping, eating and smoking habits, side effects of medications, current health problems, height and weight, blood pressure, time, duration, weight and volume of capillary, saliva, serum blood samples and dried blood spots, laboratory parameters, medication changes, intake, dosage. Not validated questions in the post survey: Evaluation of the feasibility and preference of sample collection and sample material (saliva, blood, capillary blood, dried blood spots) by the participants. | — |
Countries
Germany
Contacts
Public ContactStefanie Schreiter
Charité - Universitätsmedizin Berlin, Klinik für Psychiatrie und Psychotherapie (CCM)
Outcome results
None listed