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A Long-Term Study Continuing on From Study 04-001-01 of an Experimental Medication in Adults With Anxiety Disorder

A Long-Term, Open Label, Safety and Efficacy Study of an Experimental Medication in Adults With Generalized Anxiety Disorder (GAD)

NCT00106860•Jazz Pharmaceuticals

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (13)

Florida Clinical Research Center

Bradenton, Florida, United States

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, United States

Meridien Research

St. Petersburg, Florida, United States

CNS Research Institute (CRI)

Clementon, New Jersey, United States

Midwest Clinical Research Center

Dayton, Ohio, United States

Neurology and NeuroscienceCenter of Ohio

Toledo, Ohio, United States

IPS Research Company

Oklahoma City, Oklahoma, United States

Oregon Center for Clinical Research, Inc.

Eugene, Oregon, United States

Suburban Research Associates

Media, Pennsylvania, United States

CNS Research Institute (CRI)

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

March 1, 2005

Completion Date

March 1, 2006

Last Updated

January 9, 2008

Enrollment

158

Estimated participants

Conditions

Anxiety Disorder

Interventions

a benzodiazepine drug

DRUG

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Social Anxiety Disorder (SAD)Oppositional Defiant Disorder

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RECRUITINGNA

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AnxietyAnxiety Disorders

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2008Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Long-Term Study Continuing on From Study 04-001-01 of an Experimental Medication in Adults With Anxiety Disorder

Inclusion Criteria

Exclusion Criteria

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