LAVENDER OIL for Major depressive disorder (mild to moderate) | Major depression

Inclusion criteria

• {"criterion_text":"- Age of at least 18 years.\n- 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 severity with a duration of at least 2 weeks but not longer than one year.\n- MADRS total score for the inclusion in the run-in and into the active treatment phase: 17–30.\n- Outpatient treatment by a general or specialised physician.\n- Body weight: Body Mass Index (BMI) between 18 and 35 kg/m2.\n- Written informed consent in accordance with the legal requirement.\n- Readiness and ability on the part of the participant to comply with the physician’s instructions and to fill in the self-assessment scales."}

Exclusion criteria

• {"criterion_text":"- Participation in a further clinical trial at the same time or in the last 12 weeks before screening.\n- 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).\n- Unable to read, understand and/or complete questionnaires.\n- Diagnosis of MDD of severe severity as defined by ICD-10 (single episode: F32.2, recurrent episode: F33.2) or rating of the MADRS total score > 30 at screening or baseline visit.\n- History or suspicion of unreliability, poor cooperation or non-compliance with medical treatment.\n- Any clinically important psychiatric or neurological diagnoses according to ICD-10, other than trial indication, within 6 months before the trial such as: • Schizophrenia (F20.-), • Acute anxiety disorder (F41.-) • Episodes of depression with any characteristics of a psychotic nature (F32.3, F33.3), depressive disorders not defined as inclusion criteria (F34.1, F32.9), bipolar disorder (F31.-), cyclothymia (F34.0), mania (F30.-), • Organic, including symptomatic, mental disorders (F00-F09), • Post-traumatic stress disorder (F43.10), •\tEating disorders (F50.-).\n- History or evidence of alcohol and/or substance abuse or dependence, particularly of sedatives, hypnotics and anxiolytics. (F10-F19).\n- 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  2.\n- 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). Patients who are already well adjusted to an antidepressant therapy in the present episode may not be enrolled into this trial.\n- Any of the following treatments within 30 days before baseline visit: •\tAntidepressants •\tDepot neuroleptics •\tMonoamine oxidase (MAO) inhibitors •Pimozide •Benzodiazepines •Other psychotropic drugs •Intravenous methylene blue •Linezolid.\n- Unacceptability to discontinue or likelihood to need medication during the trial that is prohibited as concomitant treatment (see section 10.2). The following medication is not allowed during the trial: • Any psychotropic drugs including o benzodiazepines, tranquilizer, antidepressants, anxiolytics, antiepileptics, MAO inhibitors, pimozide, lamotrigine, linezolid, intravenous methylene blue o non-benzodiazepines (exception: ≤ 10 mg zolpidem/day for not longer than 10 days during the trial) o neuroleptics (exception: ≤ 75 mg melperone/day for not longer than 10 days during the trial). However, NO exception for zolpidem and for melperone is allowed within 5 days prior to any trial visit. • Long-term prophylactic treatment (e.g. lithium, carbamazepine) • Central-acting antihypertensive medication (guanethidine, guanoxan, clonidin, prazosine, α-methyldopa, reserpine) • Digoxin • Xanthine derivatives such as Theophylline • Antiparkinson medication • Phytopharmaceuticals with anxiolytic properties (e.g. hypericum extract, valerian extract) • Muscle relaxants • Analgesics of opiate type • Anaesthetics • Barbiturates • Nootropics • Coumarin derivates • Antibiotics.\n- History of hypersensitivity to lavender preparations and/or known allergies to the IMP, placebo or excipients.\n- Non-medicinal psychiatric treatment during the last 2 weeks prior to baseline visit and during the course of the trial (e.g. standardised and digital psychotherapy, sleep withdrawal, phototherapy, electroconvulsive therapy, digital health applications [DiGAs]).\n- Any unstable acute medical disorder or clinically relevant hepatic, renal, cardiovascular, respiratory, cerebrovascular, metabolic disorder or progressive diseases as cancer, haematologic diseases (including haemophilia, Christmas disease, von Willebrand’s disease, past medical history of bleeding gastric or duodenal ulcers or other significant bleeding disorders) or thyroid insufficiency (exception: non-insulin dependent diabetes mellitus, thyroid and anterior pituitary insufficiency on stable treatment), epilepsy or a history of seizure disorder or treatment with anticonvulsants for epilepsy or seizures, Parkinson’s disease.\n- Any somatic disease that necessitates regular treatment with systemic steroids.\n- Clinically significant abnormality of ECG and/or laboratory value(s) assessed at Screening Visit.\n- Any abnormal baseline finding considered by the investigator to be indicative of conditions that might affect trial results.\n- Positive pregnancy test during Visit 1.\n- Pregnancy, planning of pregnancy or lactation.\n- Persons capable of childbearing if not using highly effective contraception; these include: • Oral, intravaginal, transdermal combined (oestrogen and progestogen containing) hormonal contraception • Oral, injectable and implantable progestogen-only hormonal contraception • Intrauterine device • Intrauterine hormone-releasing system • Bilateral tubal occlusion • Vasectomised partner • Sexual abstinence (referring to heterosexual relationships)"}

Primary endpoints

• {"endpoint_text":"- The change in MADRS total score between Baseline and Week 8.","definition_or_measurement_approach":"Change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from Baseline to Week 8; MADRS total score used as primary efficacy measure."}

Secondary endpoints

• {"endpoint_text":"- Efficacy endpoint: • Changes from Baseline in Clinical Global Impressions (CGI) (Item 1), Patient Health Questionnaire-9(PHQ-9) total score, Sheehan Disability Scale (SDS) total score at Week 8","definition_or_measurement_approach":"Changes from Baseline to Week 8 in CGI Item 1, PHQ-9 total score, and SDS total score."}
• {"endpoint_text":"- Efficacy endpoint: • CGI (Item 2) at Week 8","definition_or_measurement_approach":"Clinical Global Impressions (CGI) Item 2 assessed at Week 8."}
• {"endpoint_text":"- Efficacy endpoint: • At least 50% reduction of MADRS total score between Baseline and Week 8 (responder)","definition_or_measurement_approach":"Responder defined as ≥50% reduction in MADRS total score from Baseline to Week 8."}
• {"endpoint_text":"- Efficacy endpoint: • MADRS total score < 10 at Week 8 (remitter).","definition_or_measurement_approach":"Remission defined as MADRS total score < 10 at Week 8."}
• {"endpoint_text":"- Safety endpoint:• Frequency of participants with at least one Adverse Event (AE),Adverse Drug Reaction (ADR), serious AE; number, type, severity and seriousness of AEs, and their relationship to the Investigational Medicinal Product (IMP); frequency of participants with AEs leading to withdrawal","definition_or_measurement_approach":"Safety assessed by recording frequency, type, severity and relatedness of AEs/ADRs/serious AEs and AEs leading to withdrawal."}
• {"endpoint_text":"- Safety endpoint:• Evaluation of safety assessments (physical examination, vital signs, 12-lead electrocardiography (ECG), laboratory evaluation, concomitant medication, non-medicinal psychiatric treatment)","definition_or_measurement_approach":"Safety assessments include physical exam, vital signs, 12-lead ECG, laboratory tests, concomitant medication and non-medicinal psychiatric treatments."}
• {"endpoint_text":"- Safety endpoint:• Risk of suicide","definition_or_measurement_approach":"Assessment of suicide risk (e.g., MADRS Item 10 and other safety assessments)."}

Methods

• Flyers (pharmacies) — recruitment materials titled 'K2_Recruitment material flyer pharmacies' and similar (documents associated with Part II entries).
• Online advertisement — documents include 'K2_Recruitment material online advertisement Velocity sites' indicating online ads on Velocity sites.
• Online and print media recruitment material for Sitework sites — document 'K2_Recruitment material online and printmedia recruitment material Sitework sites'.
• Prescreening toolkit questions for Pratia sites — document 'K2_Recruitment material prescreening toolkit questions Pratia sites'.
• Advertisements for Pratia and FutureMeds/Siteworks sites — multiple 'K2_Recruitment material advertisement' documents for specific site operators.

Germany

Earliest CTIS Part Ii Submission Date

04-09-2025

Latest Decision Or Authorization Date

27-02-2026

Processing Time Days

176

Number Of Sites

33

Number Of Participants

450

Austria

Earliest CTIS Part Ii Submission Date

04-09-2025

Latest Decision Or Authorization Date

19-04-2026

Processing Time Days

227

Number Of Sites

3

Number Of Participants

50

Primary sponsor

Full Name

Dr. Willmar Schwabe GmbH & Co. KG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Contract research organisations

Name

AMS Advanced Medical Services GmbH

Responsibilities

Multiple sponsor duties including regulatory submission and operational roles (codes: 1,10,11,15 'Regulatory submission',2,5,6,7)

Name

Glatt Pharmaceutical Services GmbH & Co. KG

Responsibilities

IMP distribution to sites (sponsorDuties code 15)

Name

Labor Dr. Spranger

Responsibilities

Laboratory services (sponsorDuties code 4)

Third parties

• {"country":"Germany","full_name":"Labor Dr. Spranger","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Germany","full_name":"AMS Advanced Medical Services GmbH","duties_or_roles":"sponsorDuties codes: 1, 10, 11, 15 (Regulatory submission), 2, 5, 6, 7","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Glatt Pharmaceutical Services GmbH & Co. KG","duties_or_roles":"sponsorDuties code: 15 (IMP Distribution to sites)","organisation_type":"Pharmaceutical company"}