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Clinical Trials/ISRCTN13032035
ISRCTN13032035
Completed
Not Applicable

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

Dr. Willmar Schwabe GmbH & Co. KG (Germany)0 sites220 target enrollmentSeptember 12, 2008
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ConditionsAnxiety disorder not otherwise specifiedMental and Behavioural DisordersOther anxiety disorders

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety disorder not otherwise specified
Sponsor
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Enrollment
220
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 12, 2008
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Dr. Willmar Schwabe GmbH & Co. KG (Germany)

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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