The purpose of the study is to assess the safety and effectiveness of the experimental drug, a benzodiazepine drug, in long-term use and the effects on quality of life, social and occupational functioning, sleep, and daytime sedation in subjects with anxiety disorder.

Condition	Treatment or Intervention	Phase
Anxiety Disorder	Drug: a benzodiazepine drug	Phase III

Further Study Details: 

Primary Outcomes: Assessment (over 37 additional weeks following the double-blind study) of the safety of the experimental drug in long-term use in subjects with Generalized Anxiety Disorder (GAD)
Secondary Outcomes: Evaluate the long-term efficacy of open-label study of the experimental drug in subjects with GAD; Assessment of the long-term effects on the quality of life, social and occupational functioning, sleep, and daytime sedation in subjects with GAD
Expected Total Enrollment:  158

This trial is a long-term, open label, safety and efficacy study of an experimental medication in adults with Generalized Anxiety Disorder (GAD). To enroll in this study, investigators and patients must have first participated in Jazz Pharmaceuticals, Inc. Protocol 04-001-01. The study is designed for four stages that should last a total of 37 weeks.

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Complete Study 04-001-01
• Able to take the medication for 9 months
• Understand and sign the Informed Consent
• Comply with all study-related procedures
• Women of child bearing potential must have a confirmed negative urine pregnancy test
• Lack of clinically significant abnormalities in health

Exclusion Criteria:

• Experienced any SAEs (serious adverse events) that were related or possibly related to study drug during participation in Study 04-001-01
• Early termination from study 04-001-01
• Any new condition that could interfere with the evaluation of the subject, interpretation of safety data, or compliance with the protocol requirements
• Experiencing AEs (adverse events) such that in the opinion of the investigator, per protocol, study drug administration or safe participation in this study would be precluded.
• Taken any disallowed medications noted in Study 04-001-01 between the completion of Study 04-001-01 and entry into this trial

Florida
      Clinical Neuroscience Solutions, Inc., Jacksonville,  Florida,  32216,  United States; Recruiting
Washington
      Northwest Clinical Research Center, Bellevue,  Washington,  98004,  United States; Recruiting

Study chairs or principal investigators

Murray Stein, MD,  Study Chair,  University of California, San Diego   

Study ID Numbers:  04-003
Record last reviewed:  March 2005
Last Updated:  April 1, 2005
Record first received:  March 31, 2005
ClinicalTrials.gov Identifier:  NCT00106860
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08