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 |
| Protocol serial number | 750801.01.011 |
| Sponsor | Schwabe Pharmaceuticals (Germany) |
| Funder | Dr. Willmar Schwabe GmbH & Co. KG |
- 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
Scientific
Willmar-Schwabe-Straße 4
Karlsruhe
76227
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentric, randomized, double-blind, placebo-controlled |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Hypericum extract WS® 5570 |
| Primary outcome measure(s) |
Change in the 17-HAMD total score |
| Key secondary outcome measure(s) |
Responder, remitter, |
| Completion date | 31/08/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
76227
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
