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

ISRCTN	ISRCTN77277298
DOI	https://doi.org/10.1186/ISRCTN77277298
Secondary identifying numbers	750801.01.011

Submission date: 02/12/2005
Registration date: 05/12/2005
Last edited: 16/04/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Angelika Dienel
Scientific

Willmar-Schwabe-Straße 4
Karlsruhe
76227
Germany

Study information

Study design	Multicentric, randomized, double-blind, placebo-controlled
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	Difference between active dose and placebo
Ethics approval(s)	Approved 16/01/2003
Health condition(s) or problem(s) studied	Major depressive disorder
Intervention	Hypericum extract WS® 5570 600 mg, 1200 mg, placebo
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Hypericum extract WS® 5570
Primary outcome measure	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 study start date	01/03/2003
Completion date	31/08/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	320
Key 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
Key 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
Date of first enrolment	01/03/2003
Date of final enrolment	31/08/2004

Locations

Countries of recruitment

Germany

Study participating centre

Willmar-Schwabe-Straße 4

Karlsruhe
76227
Germany

Sponsor information

Schwabe Pharmaceuticals (Germany)
Industry

Willmar-Schwabe-Straße 4
Karlsruhe
76227
Germany

"ROR"	https://ror.org/043rrkc78

Funders

Funder type

Industry

Dr. Willmar Schwabe GmbH & Co. KG

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	23/06/2006		Yes	No