Efficacy of Silexan in anxious patients

Multi-center, double-blind, placebo-controlled, randomized phase III study to prove the efficacy, safety and tolerability of Silexan (WS®1265) in patients with mixed anxiety and depressive disorder

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN65844716

Enrollment

300

Registered

2012-10-26

Start date

2012-10-29

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mixed anxiety and depressive disorder Mental and Behavioural Disorders Mixed anxiety and depressive disorder

Interventions

80 mg/day Silexan or placebo for 70 days

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of mixed anxiety and depressive disorder (ICD-10, F41.2) 2. Age 18 to 65 years 3. HAMA total score = 18 with item 1 ?anxious mood? = 2 (moderate) and item 6 ?depressed mood? = 2 (moderate) 4. BMI between 18 and 29.9 kg/m2 5. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Any clinically important psychiatric or neurological diagnoses, other than study indication, within 6 month before the study 2. Risk of suicide (MADRS item 10 = 2 during study) or previous suicide attempt or clear display of auto-aggressive behaviour 3. History or evidence of alcohol and/or substance abuse or dependence 4. Current use of other psychotropic drugs within 30 days before baseline visit 5. History of hypersensitivity to Lavender preparations 6. Any unstable acute medical disorder 7. Unacceptability to discontinue or likelihood to need medication during the study that is prohibited as concomitant treatment 8. Non-medical psychiatric treatment during the course of the study 9. Clinical significant abnormality of ECG and/or laboratory values 10. Pregnancy, lactation

Design outcomes

Primary

Measure	Time frame
The change of the HAMA total score and the MADRS total score	—

Secondary

Measure	Time frame
1. Response criteria (50 % reduction; remission) based on the HAMA total score and on the MADRS total score 2. Items 2 (tension) and 14 (behaviour at interview) of the HAMA, change and response 3. Single items and subscores of the Hamilton Rating Scale for Anxiety 4. Single items of the MADRS 5. State-Trait Anxiety Inventory (STAI) 6. Total score, subscores state anxiety and trait anxiety, early improvement on day 3 7. Subscales of the Sheehan Disability Scale (SDS) and subscores of the SF-36 8. Clinical Global Impressions 9. Hospital Anxiety and Depression Scale (HADS), total score change, subscore depression and subscore anxiety	—

Measure

Time frame

1. Response criteria (50 % reduction; remission) based on the HAMA total score and on the MADRS total score 2. Items 2 (tension) and 14 (behaviour at interview) of the HAMA, change and response 3. Single items and subscores of the Hamilton Rating Scale for Anxiety 4. Single items of the MADRS 5. State-Trait Anxiety Inventory (STAI) 6. Total score, subscores state anxiety and trait anxiety, early improvement on day 3 7. Subscales of the Sheehan Disability Scale (SDS) and subscores of the SF-36 8. Clinical Global Impressions 9. Hospital Anxiety and Depression Scale (HADS), total score change, subscore depression and subscore anxiety

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026