Multi-centre, double-blind, placebo- and reference-controlled, randomised trial to prove the efficacy and safety of Silexan (WS®1265) in patients with a major depressive episode of mild to moderate severity

Dr Willmar Schwabe (Germany)0 sites577 target enrollmentDecember 1, 2020

ConditionsMild to moderate major depressive episode Mental and Behavioural Disorders

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Mild to moderate major depressive episode
Sponsor: Dr Willmar Schwabe (Germany)
Enrollment: 577
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

2024 Results article in https://doi.org/10.1007/s00406-024-01783-2 (added 17/06/2024)

Registry

who.int

Start Date

December 1, 2020

End Date

July 5, 2023

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

Dr Willmar Schwabe (Germany)

Eligibility 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

•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