F32 F33
Conditions
Interventions
Group 1: After four weeks of adequately dosed antidepressant treatment with at least one antidepressant (at least 10mg escitalopram equivalent/die p.o., tablets) without sufficient treatment success (
Sponsors
Charité - Universitätsmedzin Berlin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: -unipolar major depression -indication for antidepressant pharmacotherapy -HAMD-17 = 12 -Inadequate response to antidepressant monotherapy and indication for lithium augmentation. -Minimum age: 18 years -physician-confirmed capacity to consent -written informed consent -No participation in an AMG study (1 month prior) and during study participation.
Exclusion criteria
Exclusion criteria: -psychotic symptoms, current -Contraindication to lithium therapy (e.g. severe renal insufficiency, pathological TSH or relevant ECG changes) - for a list of contraindications, see the technical information in the appendix. -laboratory values and/or ECG findings that speak against taking lithium -depressive syndrome due to a non-psychiatric or in the context of a further axis I diagnosis -diagnosis of dementia or organic brain disease -Diagnosis of substance dependence and use of the substance in the last 6 months (except caffeine and nicotine) -Diagnosis of an antisocial personality disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response and remission assessment using HAMD (Hamilton Depression Rating Scale) after at least four weeks of therapy with lithium carbonate in patients with treatment-resistant unipolar depression | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Tolerability and safety (Adverse Event Report, ECG, laboratory tests, self-rating questionnaires), assessment before and during lithium therapy. 2) pharmacogenetic studies 3) peripheral cytokine concentration in serum before and during lithium therapy 4) Expolorative investigation of further clinical data, e.g. childhood trauma and quality of life | — |
Countries
Germany
Contacts
Public ContactMazda Adli
Charité - Universitätsmedzin Berlin
Outcome results
None listed