30-40% of depressed patients do not respond to the first course of drug treatment chosen. Over 50% of nonresponders to the first treatment also do not respond to a second, different treatment . Of those who do respond to the initial antidepressant, up to 50% do not reach full remission but rather display residual symptoms. Therefore, treatment optimization strategies should be considered at critical decision points early in the treatment progress to avoid prolonged treatment-resistant courses.
Conditions
Interventions
Product Name: Escitalopram
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Escitalopram
CAS Number: 128196-01-0
Current Sponsor code: Escitalopram
Product Name: Lithiumcarbonat
Pharmaceutical
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - unipolar major depressive episode without psychotic symptoms - indication for antidepressant pharmacotherapy - HAMD-17 > 7 for study entry (pre-phase) and step2 (core study) - current treatment with escitalopram monotherapy (at least 10 mg/day) for a minimum of 4 weeks for entry in core study - for entry in core study: insufficient response to escitalopram monotherapy and indication for lithium-augmentation therapy - age 18-70 (male or female) - written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - psychotic symptoms - pregnant or breastfeeding patients, women of childbearing potential who are not using chemical or mechanical contraception - patients with any contraindication for the treatment with lithium (e.g. severe renal insufficiency) - patients with secondary depression due to another axis-I-comorbidity or non-psychiatric condition - diagnosis of dementia or organic brain disorder - diagnosis of substance dependency with current consumption or consumption in the last 6 months (except caffeine and nicotine) - diagnosis of antisocial personality disorder - participation in other clinical trial (current or in the last 30 days) - persons who are detained legally or officially to an official institution
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of lithium augmentation in escitalopram treated patients with a major depressive episode. Primary endpoint: time to remission (HAMD-17=7) Primary endpoint is the score on the Hamilton Depression Rating Scale for Efficacy of antidepressant therapy, safety and side effect monitoring with FISER/GRESB, PRISE and adverse event monitoring. ;Secondary Objective: To identify those patients who are most responsive to this treatment strategy, we search for genetic and clinical predictors of response to a lithium augmentation treatment with escitalopram, particularly with regard to previously published genetic predictors of lithium augmentation by our group. Of particular interest are the genetic variants of the 5HTTLPR, the GSK3B -50T/C SNP as well as of the intracellular wnt-/beta-catenin pathway. To investigate lithium-dependent gene expression of GSK3B and its correlation to clinical response by comparing mRNA expression before and under lithium treatment. To assess acceptance and life quality of patients treated with escitalopram and lithium. Secondary endpoints are the GSK3B genotyping and mRNA-expression measurement pre/post lithium-augmentation. ;Primary end point(s): | — |
Countries
Germany
Outcome results
None listed