Study of lavender oil (Silexan) in patients with mild to moderate major depressive disorder comparing its effectiveness to placebo

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What is this study about?

This study examines the use of Silexan, a lavender oil medication, in people with Major Depressive Disorder of mild to moderate severity. The study will evaluate whether taking a daily 80 mg soft capsule of Silexan works better than a placebo in reducing depression symptoms.

The purpose of this research is to determine if Silexan is effective and safe for treating mild to moderate depression. During the study, participants will take either Silexan or a placebo capsule once daily for 8 weeks. The depression symptoms will be monitored throughout the study period using various assessment tools that measure the severity of depression and how it affects daily life.

The study will track any changes in depression symptoms and monitor the overall safety of the treatment. Researchers will observe how participants respond to the medication, including whether their depression symptoms improve or if they achieve remission (very low levels of depression symptoms). They will also keep track of any side effects that may occur during the treatment period.

1 Initial assessment

You will undergo an evaluation to confirm your diagnosis of mild to moderate major depressive disorder

Your doctor will verify that you meet the required criteria, including a Montgomery-Åsberg Depression Rating Scale (MADRS) score between 17 and 30 points

A physical examination, vital signs check, heart test (ECG), and laboratory tests will be performed

2 Treatment assignment

You will be randomly assigned to receive either Silexan 80 mg or a placebo

The medication will be in the form of soft capsules for oral use

You will need to take one capsule daily

3 Treatment period

The treatment period will last for 8 weeks

During this time, you will continue taking your assigned medication daily

Your depression symptoms will be monitored using various assessment tools

Regular safety assessments will be conducted, including physical examinations and monitoring of any side effects

4 Final evaluation

At the end of week 8, a final assessment will be conducted

Your doctor will evaluate changes in your depression symptoms using the MADRS scale

Additional evaluations will include your overall clinical condition and daily functioning

Final safety assessments will be performed, including physical examination and laboratory tests

Who Can Join the Study?

  • Must be at least 18 years old
  • Must have been diagnosed with depression (mild to moderate) that has lasted for at least 2 weeks but not more than 1 year
  • Must score between 17 and 30 points on the depression rating scale (MADRS – a tool doctors use to measure depression severity)
  • Must be receiving treatment as an outpatient (not staying in hospital) from a general doctor or specialist
  • Must have a Body Mass Index (BMI) between 18 and 35 (BMI is a measure that uses your height and weight to determine if you are at a healthy weight)
  • Must provide written consent to participate in the study
  • Must be willing and able to follow doctor’s instructions and complete all required self-assessment questionnaires

Who Cannot Join the Study?

  • History of severe depression or current severe depression symptoms
  • Age below 18 or above 65 years
  • Pregnant or breastfeeding women
  • Current use of antidepressant medications
  • History of suicidal thoughts or attempts
  • Presence of other serious mental health conditions (such as bipolar disorder or schizophrenia)
  • Substance abuse or dependency within the past 6 months
  • Serious medical conditions that could affect depression symptoms
  • Participation in other clinical trials within the past 30 days
  • Known allergies to the study medication or its components
  • Inability to follow study procedures or attend scheduled visits
  • Use of medications that could interact with the study drug
  • History of non-response to depression treatments
  • Unstable medical conditions requiring frequent medication changes
  • Severe liver or kidney problems that could affect drug metabolism

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Klinische Forschung Hannover-Mitte GmbH Hanover Germany
Klinische Forschung Berlin-Mitte GmbH Berlin Germany
Klinische Forschung Hamburg GmbH Hamburg Germany
Ambenet GmbH Das Ambulante Behandlungsnetz Leipzig Germany
Hausarztzentrum Butendorf Gladbeck Germany
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbH Ulm Germany
Zentrum fuer klinische Forschung Dr. I. Schoell GmbH Bad Homburg Germany
medicoKIT GmbH Goch Germany
Siteworks GmbH Hanover Germany
Noe LGA Gesundheit Region Mitte GmbH St. Poelten Austria
Velocity Clinical Research Luebeck GmbH Luebeck Germany
Studienzentrum Bocholderstrasse Essen Germany
Klinische Forschung Schwerin GmbH Schwerin Germany
Frpnzdjfvl Gief Offenbach Am Main Germany
Kpsrusasw Fbitkzubs Dbydmno Gmsk Dresden Germany
Uliwmlrrizircbcgac fiv Pmynrrpdkfcl Ptmagvgqactht uid Pbrhduokhayxki Graz Austria
Mom Mbilcooxsqtg Ntozexzc Sckufjscwvczgu Nürnberg Germany
Scfsjfsjhouxkv Mtuzu Mqfzr Mainz Germany
Nlahabnd Cqgsds Cologne Germany
Pmstfw Sewgyql &rkxbga Gbcbab ig Kgyxyiqknaot Munster Germany
Njfujiughzls aq Kpoitpwiuwzyhxcv Grevenbroich Germany
Kep Gzqfs Gilching Germany
Smkohsforkfhve Fst Rtqfydvw Leipzig Germany
Kpkfqymn Nipjmbgzxy Nzyjmhpuwogcw Pgnaus Bamberg Germany
Adznoqo &ecjx Rvydqpx Ginl Berlin Germany
Sgaqtidohhqali Mxl Dshiga Dachau Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
15.10.2025
Germany Germany
Recruiting
15.10.2025

Trial locations

Investigated drugs:

Silexan (also known as WS 1265) is a lavender oil preparation used to treat mild to moderate major depressive disorder (MDD). It is a natural medicine derived from lavender that has shown potential antidepressant properties. The medication is taken orally once daily and works to help reduce symptoms of depression, including changes in mood, sleep patterns, and overall mental well-being.

Placebo is an inactive substance that looks identical to the active medication but contains no active ingredients. It is used as a control to measure the effectiveness of the active treatment.

Major Depressive Disorder (MDD) – A mental health condition characterized by persistent feelings of sadness, loss of interest in activities, and decreased mood that significantly affects daily life. The condition involves changes in emotions, thoughts, and behaviors that can persist for weeks or months. People with MDD often experience changes in sleep patterns, appetite, energy levels, and difficulty concentrating. MDD can range from mild to moderate to severe, with symptoms varying among individuals. The condition affects both psychological and physical well-being, impacting a person’s ability to function in work, social, and personal settings.

Trial ID:
2025-521744-37-00
Protocol code:
D.01.01.3.06
Trial Phase:
Therapeutic confirmatory (Phase III)

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