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Phase III study on the efficacy and safety of Hypericum extract WS® 5570 in patients with a Major Depressive Episode
ISRCTN ISRCTN77277298
DOI 10.1186/ISRCTN77277298
ClinicalTrials.gov identifier
EudraCT number
Public title Phase III study on the efficacy and safety of Hypericum extract WS® 5570 in patients with a Major Depressive Episode
Scientific title
Acronym N/A
Serial number at source 750801.01.011
Study hypothesis Difference between active dose and placebo
Lay summary
Ethics approval Approved 16/01/2003
Study design Multicentric, randomized, double-blind, placebo-controlled
Countries of recruitment Germany
Disease/condition/study domain Major depressive disorder
Participants - 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
Participants - 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
Anticipated start date 01/03/2003
Anticipated end date 31/08/2004
Status of trial Completed
Patient information material
Target number of participants 320
Interventions Hypericum extract WS® 5570 600 mg, 1200 mg, placebo
Primary outcome measure(s) Change in the 17-HAMD total score
Secondary outcome measure(s) Responder, remitter,
Montgomery-Åsberg Depression Rating Scale (MADRS), Beck Depression Inventory (BDI), Clinical Global Impression (CGI), safety
Sources of funding Dr. Willmar Schwabe GmbH & Co. KG
Trial website
Publications 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16796730
Contact name Dr  Angelika  Dienel
  Address Willmar-Schwabe-Straße 4
  City/town Karlsruhe
  Zip/Postcode 76227
  Country Germany
Sponsor Schwabe Pharmaceuticals (Germany)
  Address Willmar-Schwabe-Straße 4
  City/town Karlsruhe
  Zip/Postcode 76227
  Country Germany
Date applied 02/12/2005
Last edited 16/04/2008
Date ISRCTN assigned 05/12/2005
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