Phase III study on the efficacy and safety of Hypericum extract WS® 5570 in patients with a Major Depressive Episode

Completed

• Conditions: Major depressive disorder; Mental and Behavioural Disorders; Depression

• Registration Number: ISRCTN77277298
• Lead Sponsor: Schwabe Pharmaceuticals (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-05
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 320

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified