Phase III study to prove the efficacy, safety and tolerability of Silexan® in patients with anxiety disorder

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13032035

Enrollment

220

Registered

2008-09-12

Start date

2004-09-16

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

Anxiety disorder not otherwise specified Mental and Behavioural Disorders Other anxiety disorders

Interventions

Silexan® 80 mg (1 capsule) per day or placebo orally for 10 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age range: 18 - 65, both males and females 2. Primary diagnosis of an anxiety disorder NOS according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV; 300.00) 3. Severity of anxiety for the inclusion: the Hamilton Anxiety Scale (HAM-A) total score >=18, Item 1 "anxious mood" >=2, Item 2 "insomnia" >=2 4. Severity of sleep disorders for the inclusion: Pittsburgh Sleep Quality Index (PSQI) total score >5

Exclusion criteria

Exclusion criteria: 1. A decrease of 25% or more of the HAM-A total score during the screening phase 2. Any clinically important psychiatric or neurological diagnoses other than an anxiety disorder NOS within 6 month before the study 3. Risk of suicide 4. History or evidence of alcohol and/or substance abuse or dependence 5. Current use of other psychotropic drugs 6. Any unstable acute medical disorder 7. Prohibited concomitant treatment: any psychotropic drugs including benzodiazepines, non-benzodiazepines (zopiclone, zolpidem), neuroleptics, tranquiliser, antidepressives, antiepileptics, antihistaminics 8. Long-term prophylactic treatment 9. Central-acting antihypertensive medication 10. Anti-Parkinson's medication 11. Phyto-anxiolytics 12. Muscle relaxants 13. Analgetics of opiate type 14. Anaesthetics 15. Barbiturates 16. Nootropics 17. Non-medical psychiatric treatment

Design outcomes

Primary

Measure	Time frame
1. Change in HAMA total score, assessed every 2 weeks for 10 weeks 2. Change in PSQI total score, assessed at baseline and Week 2, 6 and 10	—

Secondary

Measure	Time frame
1. Subscores of HAMA, assessed every 2 weeks for 10 weeks 2. Subscores of PSQI, assessed at baseline and Week 2, 6 and 10 3. Clinical Global Impressions (CGI) scale at baseline, Week 8 and 10 4. Zung's Self-rating Anxiety Scale, assessed every 2 weeks for 10 weeks 5. Short-Form 36 (SF-36) Health Survey Questionnaire at baseline and Week 10 6. Safety, assessed every 2 weeks for 10 weeks. After this period, adverse events were monitored until they had subsided or had stabilised.	—

Measure

Time frame

1. Subscores of HAMA, assessed every 2 weeks for 10 weeks 2. Subscores of PSQI, assessed at baseline and Week 2, 6 and 10 3. Clinical Global Impressions (CGI) scale at baseline, Week 8 and 10 4. Zung's Self-rating Anxiety Scale, assessed every 2 weeks for 10 weeks 5. Short-Form 36 (SF-36) Health Survey Questionnaire at baseline and Week 10 6. Safety, assessed every 2 weeks for 10 weeks. After this period, adverse events were monitored until they had subsided or had stabilised.

—

Countries

Germany

Outcome results

None listed

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