Major depressive disorder Mental and Behavioural Disorders Depression
Conditions
Interventions
Hypericum extract WS® 5570 600 mg, 1200 mg, placebo
Sponsors
Schwabe Pharmaceuticals (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of a major depressive episode according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (single episode: 296.21, 296.22, recurrent episode: 296.31, 296.32) 2. Severity of depression on the baseline visit: Hamilton rating scale for depression (17-HAMD) total score =18 and HAMD item 'depressive mood' =2
Exclusion criteria
Exclusion criteria: 1. Any of the following psychiatric diagnosis according to DSM-IV: schizophrenia (295.x, 297.x, 298.x), acute anxiety disorder (300.x, 302.x) as primary diagnosis, adjustment disorder (309.x), episodes of depression with any characteristics of a psychotic nature (296.24, 296.34), depressive disorders not defined as inclusion criteria (e.g. 300.4, 311), bipolar disorder (296.0, 296.4, 296.5, 296.6, 296.7, 296.8, 301.13), organic mental disorder (International Statistical Classification of Diseases and Related Health Problems - tenth revision [ICD-10]: F06), acute post traumatic stress disorder (309.81), abuse of any substance; risk of suicide 2. Lack of response to any adequate antidepressant therapy in the present episode 3. Duration of the index episode greater than 1 year 4. Concomitant medication with any psychotropic drug 5. Any clinical relevant hepatic, renal, cardiovascular, respiratory, cerebrovascular, metabolic disorder or progressive diseases
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Responder, remitter, Montgomery-Åsberg Depression Rating Scale (MADRS), Beck Depression Inventory (BDI), Clinical Global Impression (CGI), safety | — |
Primary
| Measure | Time frame |
|---|---|
| Change in the 17-HAMD total score | — |
Countries
Germany
Outcome results
None listed