Predictive relevance of genetic polymorphisms in the glycogen-synthase-kinase-3beta (GSK3B) mediated intracellular signal transduction for the efficacy of lithium augmentation of antidepressants in the treatment-resistant major depressio

Not Applicable

Recruiting

• Conditions: F32; F33; Depressive episode; Recurrent depressive disorder

• Registration Number: DRKS00026205
• Lead Sponsor: Charité - Universitätsmedzin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 500

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

-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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1) Tolerability and safety (Adverse Event Report, ECG, laboratory tests, self-rating questionnaires), assessment before and during lithium therapy.<br>2) pharmacogenetic studies<br>3) peripheral cytokine concentration in serum before and during lithium therapy<br>4) Expolorative investigation of further clinical data, e.g. childhood trauma and quality of life