NCT00106860

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 1, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

January 9, 2008

Status Verified

January 1, 2008

First QC Date

March 31, 2005

Last Update Submit

January 7, 2008

Conditions

Anxiety Disorder

Keywords

AnxietyGeneralized Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • 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

Interventions

a benzodiazepine drugDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Florida Clinical Research Center

Bradenton, Florida, 34208, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32216, United States

Location

Meridien Research

St. Petersburg, Florida, 33709, United States

Location

CNS Research Institute (CRI)

Clementon, New Jersey, 08021, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45408, United States

Location

Neurology and NeuroscienceCenter of Ohio

Toledo, Ohio, 43623, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73103, United States

Location

Oregon Center for Clinical Research, Inc.

Eugene, Oregon, 97401, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19603, United States

Location

CNS Research Institute (CRI)

Philadelphia, Pennsylvania, 19149, United States

Location

Future Search Trials

Austin, Texas, 78756, United States

Location

Comprehensive Neuroscience of Northern Virginia

Falls Church, Virginia, 22041, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98004, United States

Location

MeSH Terms

Conditions

Anxiety DisordersGeneralized Anxiety Disorder

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Murray Stein, MD

    University of California, San Diego

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 31, 2005

First Posted

April 1, 2005

Study Start

March 1, 2005

Study Completion

March 1, 2006

Last Updated

January 9, 2008

Record last verified: 2008-01

Locations

US(13)