Major depressive episode according to DSM-IV (single episode: 296.22, recurrent episode: 296.32
Conditions
Interventions
Product Name: Hypericum Extrakt WS 5570
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age => 18 years and 22 and HAMD item “depressive mood” => 2 5. Patient is able to comply with the physician’s instructions and to fill in the self rating scales Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Participation in a further clinical trial at the same time or within the past 4 weeks 2. 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 (ICD-10: F06), acute post traumatic stress disorder (309.81), abuse of any substance 3. Risk of suicide, or previous suicide attempt or clear display of auto-aggresive behaviour 4. Lack of response to any adequate antidepressant therapy in the present episode of depression (adequate means => 150 mg amitriptyline-equivalents per day or SSRI treatment during at least 6 weeks) 5. Duration of the index episode > 1 year 6. Any of the following treatments within the indicated intervals before baseline visit: depot neuroleptics (2 months), MAO inhibitors (6 weeks, exception: moclobemide or other RIMAs), fluoxetine (6 weeks), benzodiazepines (2 weeks), other psychotropic drugs (1 week) 7. Non-medical psychiatric treatment during the last two weeks (e.g. standardised psychotherapy, sleep withdrawal, phototherapy, ECT) 8. Prohibited concomitant medication: any psychotropic drug (incl. benzodiazepines), antihypertensive medication with guanethidine, guanoxan, clonidin, prazosine, a-methyldopa, sedative drugs including antihistaminics (exception: <= 10 mg Stilnox® (zolpidem)/day), longterm prophylactic treatment (e.g. lithium, carbamazepine), reserpine, coumarine derivates, ciclosporine, digoxin, indinavir and other protease inhibitors in anti HIV treatment, theophylline 9. History of hypersensitivity to hypericum extract 10. Known photosensitivity 11. Any clinically relevant hepatic, renal, cardiovascular, respiratory, cerebrovascular, metabolic disorder or progressive diseases as cancer, haematologic diseases or thyroid insufficiency (exception: metabolic diseases like diabetes mellitus or anterior pituitary insufficiency on stable treatment), epilepsy or a history of seizure disorder or treatment with anticonvulsants for epilepsy or seizures, Parkinson’s disease 12. Pregnancy or lactation 13. Patients capable of childbearing if not using adequate contraception (intra-uterine devices or injectable contraception; if hormonal oral contraceptives are used, a second contraception such as condoms are mandatory) 14. Gastrointestinal disorders with uncertain absorption of orally administered drugs (e.g. partial or total gastrectomy, enterectomy, inflammatory bowel disease, celiac disease, symptomatic lactose intolerance, other disorders associated with chronic diarrhoea)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to confirm the clinical efficacy and safety of Hypericum extract WS® 5570 in a twice a day application schedule in patients with a major depressive episode of moderate severity with the selected rating scales 17-HAMD, BDI, CGI, SF-36, DISS and global rating of satisfaction with therapy result.;Secondary Objective: ;Primary end point(s): The primary endpoint is defined as: change from baseline (visit 2) to the individual last visit (visit 6 = day 71; visit 10 = day 183 or last day in study in case of premature termination) in the 17-HAMD total score. For confirmatory analysis, the difference to day 71 (visit 6) or last visit in the acute treatment phase in case of premature termination will be considered. For descriptive analysis of the continuation phase the difference between baseline (visit 2) and day 183 (visit 10) or last visit in the continuation phase in case of premature termination as well as between day 71 (visit 6) and day 183 (visit 10) or last visit in the continuation phase in case of premature termination will be observed. | — |
Countries
Germany
Outcome results
None listed