Major depressive episode of moderate severity
Conditions
Interventions
Product Name: Sokatin®
Pharmaceutical Form: Tablet
Current Sponsor code: WS® 1261
Concentration unit: mg milligram(s)
Concentration number: 100-
Pharmaceutical form of the placebo: Tablet
Route of adm
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age between 18 years and 65 years 2. Informed consent in accordance with the legal requirements. Patient is able to provide informed consent for the study (legally competent, physically and mentally capable of giving consent) 3. Diagnosis of a major depressive episode of moderate severity according to DSM-IV (single episode: 296.22, recurrent episode: 296.32; duration at least two weeks but not longer than one year). Anxiety may be present if not requiring specific treatment. 4. Severity of depression on the baseline visit: MADRS total score greater or equal 22 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, 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), current abuse or dependence of any substance (except nicotine) or within the last two years 3. Risk of suicide, or previous suicide attempt or clear display of auto-aggresive behaviour as defined (but not limited to) MADRS item 10, score greater or equal 4 4. Lack of response to any adequate antidepressant therapy in the present episode of depression (adequate means: greater or equal 150 mg amitriptyline-equivalents per day or greater or equal 450 mg hypericum extract 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, antidepressants, OTC-drugs), antihypertensive medication with guanethidine, guanoxan, clonidin, prazosine, alpha-methyldopa, sedative drugs including antihistaminics (exception: less or equal 10 mg Stilnox® (zolpidem)/day), longterm prophylactic treatment (e.g. lithium, carbamazepine), reserpine 9. History of hypersensitivity to preparations from any part of cacteae 10. 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 11. Pregnancy or lactation 12. Patients capable of childbearing if not using adequate contraception (intra-uterine devices, oral or injectable contraception) 13. Body Mass index > 35 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) 15. Patient is committted to an institution by order of authorities or a court's decision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To find the effective dose of Sokatin® (WS® 1261) and to confirm the safety of up to 500mg Sokatin® (WS® 1261) in patients with a major depressive episode of moderate severity Change in the MADRS total score between baseline and the individual last visit of the treatment period ;Secondary Objective: Responder rates whereby response is defined as at least 50% reduction of the MADRS total score between baseline and the individual last visit of the treatment period; Remission rates whereby remission is defined as total score of the MADRS below 10 points at the individual last visit of the treatment period. Change in the 17-HAMD total score between baseline and the individual last visit of the treatment period; Responder rates whereby response is defined as at least 50% reduction of the 17-HAMD total score between baseline and the individual last visit of the treatment period ; Remission rates whereby remission is defined as total score of the 17-HAMD below 8 points at the individual last visit of the treatment period Further outcome variables: MADRS single items, CGI, BDI, global rating of satisfaction with therapy result at individual last visit of the acute treatment period; SF 36, Sheehan Disability Scale. Safety and tolerability during the treatment ;Primary end point(s): The primary endpoint is defined as: change from baseline (visit 2) to the individual last visit (visit 5 = day 57 or last day in study in case of premature termination) in the MADRS total score. For confirmatory analysis, the difference to day 57 (visit 5) or individual last visit in the treatment phase in case of premature termination will be considered. | — |
Countries
Germany
Outcome results
None listed