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

Completed

• Conditions: Anxiety disorder not otherwise specified; Mental and Behavioural Disorders; Other anxiety disorders

• Registration Number: ISRCTN13032035
• Lead Sponsor: Dr. Willmar Schwabe GmbH & Co. KG (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-12
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 220

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified