Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Treatment Expectations |
Treatment Credibility Scale (TCS) |
week -1 |
|
Primary |
Depression Severity: clinician-rated |
Hamilton Rating Scale for Depression (HAMD-17) |
week 6 |
|
Secondary |
Depression Severity: clinician-rated |
Hamilton Rating Scale for Depression (HAMD-17) |
week 1 |
|
Secondary |
Depression Severity: clinician-rated |
Hamilton Rating Scale for Depression (HAMD-17) |
week 3 |
|
Secondary |
Depression Severity: clinician-rated |
Hamilton Rating Scale for Depression (HAMD-17) |
week 12 |
|
Secondary |
Depression Severity: patient-rated |
Beck Depression Inventory II (BDI-II) |
week 1 |
|
Secondary |
Depression Severity: patient-rated |
Beck Depression Inventory II (BDI-II) |
week 3 |
|
Secondary |
Depression Severity: patient-rated |
Beck Depression Inventory II (BDI-II) |
week 6 |
|
Secondary |
Depression Severity: patient-rated |
Beck Depression Inventory II (BDI-II) |
week 12 |
|
Secondary |
Global improvement: clinician-rated |
Clinical Global Impression Scale (CGI) |
week 1 |
|
Secondary |
Global improvement: clinician-rated |
Clinical Global Impression Scale (CGI) |
week 3 |
|
Secondary |
Global improvement: clinician-rated |
Clinical Global Impression Scale (CGI) |
week 6 |
|
Secondary |
Global Improvement: clinician-rated |
Clinical Global Impression Scale (CGI) |
week 12 |
|
Secondary |
Global Functioning: clinician-rated |
Global Assessment of Functioning Scale (GAF) |
week 1 |
|
Secondary |
Global Functioning: clinician-rated |
Global Assessment of Functioning Scale (GAF) |
week 3 |
|
Secondary |
Global Functioning: clinician-rated |
Global Assessment of Functioning Scale (GAF) |
week 6 |
|
Secondary |
Global Functioning: clinician-rated |
Global Assessment of Functioning Scale (GAF) |
week 12 |
|
Secondary |
Fatigue: patient-rated |
Multidimensional Fatigue Inventory (MFI) |
week 1 |
|
Secondary |
Fatigue: patient-rated |
Multidimensional Fatigue Inventory (MFI) |
week 3 |
|
Secondary |
Fatigue: patient-rated |
Multidimensional Fatigue Inventory (MFI) |
week 6 |
|
Secondary |
Fatigue: patient-rated |
Multidimensional Fatigue Inventory (MFI) |
week 12 |
|
Secondary |
Stress: patient-rated |
Perceived Stress-Scale (PSS) |
week 1 |
|
Secondary |
Stress: patient-rated |
Perceived Stress-Scale (PSS) |
week 3 |
|
Secondary |
Stress: patient-rated |
Perceived Stress-Scale (PSS) |
week 6 |
|
Secondary |
Stress: patient-rated |
Perceived Stress-Scale (PSS) |
week 12 |
|
Secondary |
Quality of Life: patient-rated |
Short Form Health Survey (SF-12) |
week 1 |
|
Secondary |
Quality of Life: patient-rated |
Short Form Health Survey (SF-12) |
week 3 |
|
Secondary |
Quality of Life: patient-rated |
Short Form Health Survey (SF-12) |
week 6 |
|
Secondary |
Quality of Life: patient-rated |
Short Form Health Survey (SF-12) |
week 12 |
|
Secondary |
Biomarkers: interleukin 2 |
IL-2 |
week 1 |
|
Secondary |
Biomarkers: interleukin 2 |
IL-2 |
week 3 |
|
Secondary |
Biomarkers: interleukin 2 |
IL-2 |
week 6 |
|
Secondary |
Biomarkers: interleukin 2 |
IL-2 |
week 12 |
|
Secondary |
Biomarkers: interleukin 6 |
IL-6 |
week 1 |
|
Secondary |
Biomarkers: interleukin 6 |
IL-6 |
week 3 |
|
Secondary |
Biomarkers: interleukin 6 |
IL-6 |
week 6 |
|
Secondary |
Biomarkers: interleukin 6 |
IL-6 |
week 12 |
|
Secondary |
Biomarkers: interleukin 10 |
IL-10 |
week 1 |
|
Secondary |
Biomarkers: interleukin 10 |
IL-10 |
week 3 |
|
Secondary |
Biomarkers: interleukin 10 |
IL-10 |
week 6 |
|
Secondary |
Biomarkers: interleukin 10 |
IL-10 |
week 12 |
|
Secondary |
Biomarkers: tumor necrosis factor alpha |
TNF-alpha |
week 1 |
|
Secondary |
Biomarkers: tumor necrosis factor alpha |
TNF-alpha |
week 3 |
|
Secondary |
Biomarkers: tumor necrosis factor alpha |
TNF-alpha |
week 6 |
|
Secondary |
Biomarkers: tumor necrosis factor alpha |
TNF-alpha |
week 12 |
|
Secondary |
Biomarkers: high-sensitivity C-reactive protein |
hs-CRP |
week 1 |
|
Secondary |
Biomarkers: high-sensitivity C-reactive protein |
hs-CRP |
week 3 |
|
Secondary |
Biomarkers: high-sensitivity C-reactive protein |
hs-CRP |
week 6 |
|
Secondary |
Biomarkers: high-sensitivity C-reactive protein |
hs-CRP |
week 12 |
|
Secondary |
Biomarkers: soluble intercellular adhesion molecule-1 |
sICAM-1 |
week 1 |
|
Secondary |
Biomarkers: soluble intercellular adhesion molecule-1 |
sICAM-1 |
week 3 |
|
Secondary |
Biomarkers: soluble intercellular adhesion molecule-1 |
sICAM-1 |
week 6 |
|
Secondary |
Biomarkers: soluble intercellular adhesion molecule-1 |
sICAM-1 |
week 12 |
|
Secondary |
Biomarkers: tryptophan |
tryptophan |
week 1 |
|
Secondary |
Biomarkers: tryptophan |
tryptophan |
week 3 |
|
Secondary |
Biomarkers: tryptophan |
tryptophan |
week 6 |
|
Secondary |
Biomarkers: tryptophan |
tryptophan |
week 12 |
|
Secondary |
Biomarkers: kynurenine |
kynurenine |
week 1 |
|
Secondary |
Biomarkers: kynurenine |
kynurenine |
week 3 |
|
Secondary |
Biomarkers: kynurenine |
kynurenine |
week 6 |
|
Secondary |
Biomarkers: kynurenine |
kynurenine |
week 12 |
|
Secondary |
Biomarkers: neopterin |
neopterin |
week 1 |
|
Secondary |
Biomarkers: neopterin |
neopterin |
week 3 |
|
Secondary |
Biomarkers: neopterin |
neopterin |
week 6 |
|
Secondary |
Biomarkers: neopterin |
neopterin |
week 12 |
|
Secondary |
Adverse Events |
Number of patients with adverse events, total number and type of adverse events |
week 1 |
|
Secondary |
Adverse Events |
Number of patients with adverse events, total number and type of adverse events |
week 3 |
|
Secondary |
Adverse Events |
Number of patients with adverse events, total number and type of adverse events |
week 6 |
|
Secondary |
Adverse Events |
Number of patients with adverse events, total number and type of adverse events |
week 12 |
|