Clinical trial NCT00106860: A Long-Term Study Continuing on From Study 04-001-01 of an Experimental Medication in Adults With Anxiety Disorder
Official title: A Long-Term, Open Label, Safety and Efficacy Study of an Experimental Medication in Adults With Generalized Anxiety Disorder (GAD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anxiety Disorder
Keywords: Anxiety
Generalized Anxiety Disorder
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-04-01
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: 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:
measure: Evaluate the long-term efficacy of open-label study of the experimental drug in subjects with GAD
measure: Assessment of the long-term effects on the quality of life, social and occupational functioning, sleep, and daytime sedation in subjects with GAD
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: Florida Clinical Research Center
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: St. Petersburg
country: United States
facility: Meridien Research
state: Florida
city: Clementon
country: United States
facility: CNS Research Institute (CRI)
state: New Jersey
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Toledo
country: United States
facility: Neurology and NeuroscienceCenter of Ohio
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Eugene
country: United States
facility: Oregon Center for Clinical Research, Inc.
state: Oregon
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: CNS Research Institute (CRI)
state: Pennsylvania
city: Austin
country: United States
facility: Future Search Trials
state: Texas
city: Falls Church
country: United States
facility: Comprehensive Neuroscience of Northern Virginia
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
affiliation: University of California, San Diego
name: Murray Stein, MD
role: STUDY_CHAIR
References: