mixed anxiety and depressive disorder (ICD-10, F41.2) MedDRA version: 14.1 Level: LLT Classification code 10027741 Term: Mixed anxiety & depressive System Organ Class: 100000004873
Conditions
Interventions
Trade Name: Lasea®
Product Name: Silexan
Product Code: WS® 1265
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Lavenderoil
Other descriptive name: Silexan (WS® 1265)
Concentration unit: mg mi
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis of mixed anxiety and depressive disorder (ICD-10, F41.2). Age: 18 to 65 years. Out-patient treatment by a specialized physician. Severity of disorder for the inclusion in the wash-out and into the acute treatment phase: HAMA total score = 18 with item 1 „anxious mood“ = 2 (moderate) and item 6 „depressed mood“ = 2 (moderate). Normal body weight: BMI between 18 and 29.9 kg/m2 Written informed consent in accordance with the legal requirement. Readiness and ability on the part of the patient to comply with the physician’s instructions and to fill in the self-assessment scales. Negative pregnancy test within 5 days before study start in females of childbearing potential before study start). Use of adequate contraception by female with childbearing potential 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 300 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any clinically important psychiatric or neurological diagnoses, other than study indication, within 6 month before the study (such as major depression, generalized anxiety disorder, unexplained somatic symptoms, bipolar disorder, alcohol use disorder or drug use disorder). Risk of suicide or previous suicide attempt or clear display of auto-aggressive behaviour. Risk of suicide is defined by a score of MADRS item 10 = 2. History or evidence of alcohol and/or substance abuse or dependence, particularly of sedatives, hypnotics and anxiolytics. (303.90; 305.00;304.10; 305.40) Current use of other psychotropic drugs within 30 days before baseline visit. History of hypersensitivity to Lavender preparations. Any unstable acute medical disorder. Unacceptability to discontinue or likelihood to need medication during the study that is prohibited as concomitant treatment. Non-medical psychiatric treatment (e.g., specific standardized psychotherapy) during the course of the study. Treatment with any other investigational drug in the last 12 weeks before screening. Clinical significant abnormality of ECG and/or laboratory values. Any abnormal baseline finding considered by the investigator to be indicative of conditions that might affect study results. Pregnancy, lactation. History or suspicion of unreliability, poor cooperation or non-compliance with medical treatment. 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). Exclusion criteria during the course of the clinical trial: MADRS Item 10 = 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is to prove the efficacy of Silexan (WS®1265) in the treatment of patients with mixed anxiety and depressive disorder in comparing the change of the HAMA total score and the MADRS total score between baseline and Week 10 between Silexan and placebo.;Secondary Objective: Secondary objective is to confirm the safety of Silexan (WS®1265) ;Primary end point(s): The change of the HAMA total score and the MADRS total score.;Timepoint(s) of evaluation of this end point: Week 1, 2, 4, 7, 10. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Response criteria (50 % reduction; remission) based on the HAMA total score and on the MADRS total score. Items 2 (tension) and 14 (behaviour at interview) of the HAMA, change and response. Single items and subscores of the Hamilton Rating Scale for Anxiety, single items of the MADRS. State-Trait Anxiety Inventory (STAI), total score, subscores state anxiety and trait anxiety, early improvement on day 3. Subscales of the Sheehan Disability Scale (SDS) and subscores of the SF-36. Clinical Global Impressions. Hospital Anxiety and Depression Scale (HADS), total score change; subscore depression and subscore anxiety.;Timepoint(s) of evaluation of this end point: Week 1, 2, 4, 7, 10 (HAMA, MADRS, HADS, STAI). Week 10 (SDS, SF 36). Day 3 (STAI) | — |
Countries
Germany
Contacts
Public ContactClinical Research Department
Dr. Willmar Schwabe GmbH & Co. KG
Outcome results
None listed