Condition category
Mental and Behavioural Disorders
Date applied
02/12/2005
Date assigned
05/12/2005
Last edited
16/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Angelika Dienel

ORCID ID

Contact details

Willmar-Schwabe-Straße 4
Karlsruhe
76227
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

750801.01.011

Study information

Scientific title

Acronym

Study hypothesis

Difference between active dose and placebo

Ethics approval

Approved 16/01/2003

Study design

Multicentric, randomized, double-blind, placebo-controlled

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Major depressive disorder

Intervention

Hypericum extract WS® 5570 600 mg, 1200 mg, placebo

Intervention type

Drug

Phase

Phase III

Drug names

Hypericum extract WS® 5570

Primary outcome measures

Change in the 17-HAMD total score

Secondary outcome measures

Responder, remitter,
Montgomery-Åsberg Depression Rating Scale (MADRS), Beck Depression Inventory (BDI), Clinical Global Impression (CGI), safety

Overall trial start date

01/03/2003

Overall trial end date

31/08/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

320

Participant 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

Recruitment start date

01/03/2003

Recruitment end date

31/08/2004

Locations

Countries of recruitment

Germany

Trial participating centre

Willmar-Schwabe-Straße 4
Karlsruhe
76227
Germany

Sponsor information

Organisation

Schwabe Pharmaceuticals (Germany)

Sponsor details

Willmar-Schwabe-Straße 4
Karlsruhe
76227
Germany

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Dr. Willmar Schwabe GmbH & Co. KG

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16796730

Publication citations

  1. Results

    Kasper S, Anghelescu IG, Szegedi A, Dienel A, Kieser M, Superior efficacy of St John's wort extract WS 5570 compared to placebo in patients with major depression: a randomized, double-blind, placebo-controlled, multi-center trial [ISRCTN77277298]., BMC Med, 2006, 4, 14, doi: 10.1186/1741-7015-4-14.

Additional files

Editorial Notes