Mild to moderate major depressive episode Mental and Behavioural Disorders Mild to moderate major depressive episode
Conditions
Interventions
Patients will be randomly allocated to receive either:
1 x 1 capsule with a daily total of 80 mg Silexan (WS® 1265) and 1 x 1 capsule Sertraline placebo OR
1 x 1 capsule with a daily total of 50 mg Se
Sponsors
Dr Willmar Schwabe (Germany)
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age of at least 18 years 2. Diagnosis of a major depressive episode according to ICD 10 (single episode: F32.0, 32.1, recurrent episode: F33.0, 33.1) of mild to moderate intensity 3. MADRS total score for the inclusion in the run-in and into the acute treatment phase: 19 - 34 4. Out-patient treatment by a general or specialized physician 5. BMI between 18 and 35 kg/m² 6. Written informed consent in accordance with the legal requirement 7. Readiness and ability on the part of the patient to comply with the physician’s instructions and to fill in the self-assessment scales
Exclusion criteria
Exclusion criteria: 1. Participation in a further clinical trial at the same time or in the last 12 weeks before screening 2. Diagnosis of MDD of severe intensity as defined by ICD-10 (single episode: F32.2, recurrent episode: F33.2) or rating of the MADRS total score >34 at baseline visit 3. Any clinically important psychiatric or neurological diagnoses according to ICD-10, other than study indication, within 6 months before the study 4. History or evidence of alcohol and/or substance abuse or dependence, particularly of sedatives, hypnotics and anxiolytics (F10- F19) 5. Risk of suicide, or previous suicide attempt or clear display of auto-aggressive behaviour as defined (but not limited to) MADRS item 10 “suicidal thoughts” score =1 and or a (BSS)-5-Item Screen score =1 6. Lack of response to any adequate antidepressant therapy in the present episode of depression or lack of response to Sertraline in any previous episode. Patients who are already well adjusted to an antidepressant therapy in the present episode may not be enrolled into this study 7. Any of the following treatments within 30 days before baseline visit: Antidepressants, depot neuroleptics, MAO inhibitors, pimozide, benzodiazepines, other psychotropic drugs, intravenous methylene blue, linezolid 8. Unacceptability to discontinue or likelihood to need medication during the study that is prohibited as concomitant treatment. The following medication is not allowed during the study: any psychotropic drugs, long-term prophylactic treatment (e.g. lithium, carbamazepine), central-acting antihypertensive medication (guanethidine, guanoxan, clonidin, prazosine, a-methyldopa, reserpine), digoxin, xanthine derivatives such as Theophylline, antiparkinson medication, phytopharmaceuticals with anxiolytic properties, muscle relaxants, analgesics of opiate type, anaesthetics, barbiturates, nootropics, coumarin derivates 9. Non-medicinal psychiatric treatment during the last two weeks prior to baseline visit and during the course of the study 10. History of hypersensitivity to Lavender preparations or Sertraline and/or known allergies to the IMP, placebo or excipients 11. Any unstable acute medical disorder or clinically relevant hepatic, renal, cardiovascular, respiratory, cerebrovascular, metabolic disorder or progressive diseases as cancer, haematologic diseases or thyroid insufficiency, epilepsy or a history of seizure disorder or treatment with anticonvulsants for epilepsy or seizures, Parkinson’s disease 12. Any somatic disease that necessitate regular treatment with systemic steroids 13. Medical history of angle-closure glaucoma or untreated anatomical "narrow angles" in any eye 14. Medical history of syndrome of inappropriate antidiuretic hormone secretion (SIADH) or hyponatremia in the laboratory analysis at visit 1 15. Clinically significant abnormality of ECG and/or laboratory value 16. Any abnormal baseline finding considered by the investigator to be indicative of conditions that might affect study results 17. Positive pregnancy test during visit 1 18. Pregnancy, planning of pregnancy or lactation 19. Patients capable of childbearing if not using adequate contraception, depending on the gender of the patient the respective contraception applies to their partners during the trial period 20. Gastrointestinal disorders with uncertain absorption of orally administered drugs 21. Unable to read, understand and/or complete questionnaires 22. History or suspicion of unreliability, poor cooperation or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depression measured using the Montgomery-Asberg-Depression Rating Scale (MADRS total score) at baseline and week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| At baseline and week 8: 1. Depression measured using single items of the MADRS 2. Depression measured using Beck depression inventory (BDI-II) total score 3. Clinical Global Impressions of severity of disorder (CGI Item 1) as an organized global assessment of severity conducted by the investigator 4. General health measured using the patient health questionnaire (PHQ-9) total score 5. Sheehan disability (SDS) total score for the documentation of social functioning 6. Clinical global impression of change from baseline (CGI Item 2) as an organized global assessment of change from baseline conducted by the investigator at week 8 Safety outcomes: 1. Rate of patients who discontinue the randomized treatment prematurely due to inefficacy or intolerability 2. Rate of subjects suffering from a (serious) adverse event or a (serious) adverse drug reaction during the treatment phase or the post treatment exposure phase 3. Rate of subjects with item 10 of MADRS > 0 at any individual visit 4. Rate of subjects with Beck Scale for Suicide Ideation (BSS)-5-Item Screen total score > 0 at any individual visit 5. Laboratory values from blood and urine test: 5.1. At the first visit: 5.1.1. Haematology: erythrocytes, platelets, haemoglobin, haematocrit, leucocytes 5.1.2. Metabolites: creatinine, glucose, TSH; Liver enzymes: ASAT (SGOT), ALAT (SGPT), gamma-GT 5.1.3. Coagulation: prothrombin time (PTT), thromboplastin time (Quick), fibrinogen 5.1.4. Electrolytes: sodium, potassium 5.1.5. Urinalysis: protein, glucose, blood 5.2. At visits 2, 3, 5 and 7: Electrolytes: sodium, potassium 5.3. At the last visit: 5.3.1. Liver enzymes: ASAT (SGOT), ALAT (SGPT), gamma-GT 5.3.2. Metabolites: creatinine 6. Vital signs: blood pressure (mmHg), heart rate (bpm) measured using 12-lead ECG at baseline and week 8 7. Physical examination by the researcher to identify potential abnormalities at baseline and week 8 | — |
Countries
Germany
Outcome results
None listed