Clinical Study Assessing a New Scale to Measure Onset of Action in Generalized Anxiety Disorder
NCT ID: NCT00715039
Last Updated: 2008-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
169 participants
INTERVENTIONAL
2003-10-31
2004-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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lorazepam
lorazepam
1.0 mg p.o. three times a day for three days, then 1.5mg p.o. three times a day for 25 days
placebo
placebo
placebo p.o. t.i.d. for 28 days; placebo matching lorazepam and paroxetine
paroxetine
paroxetine
20mg p.o. daily for 28 days; and matching placebo twice a day to maintain blind
Interventions
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lorazepam
1.0 mg p.o. three times a day for three days, then 1.5mg p.o. three times a day for 25 days
placebo
placebo p.o. t.i.d. for 28 days; placebo matching lorazepam and paroxetine
paroxetine
20mg p.o. daily for 28 days; and matching placebo twice a day to maintain blind
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HAM A score ³20 at the Screening (Study Day -7) and Baseline (Study Day 1) Visits by observer rating
* Good health as determined by medical history, physical examination, vital signs, electrocardiography (ECG), and clinical laboratory measurements
* Covi Anxiety Scale total score ³9 and Raskin Depression Scale total score £7 at the Screening Visit (to ensure predominance of anxiety symptoms over depression symptoms)
* Age 18 to 65 (inclusive)
Exclusion Criteria
* Patients with current or past schizophrenia, Psychotic disorder
* Delirium, dementia, amnestic, and other clinically significant cognitive disorders
* Bipolar or schizoaffective disorder
* Benzodiazepine abuse or dependence; and/or Factitious disorder.
18 Years
65 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Glendale, California, United States
Pfizer Investigational Site
Northridge, California, United States
Pfizer Investigational Site
Orange, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
Sherman Oaks, California, United States
Pfizer Investigational Site
Van Nuys, California, United States
Pfizer Investigational Site
Casselberry, Florida, United States
Pfizer Investigational Site
Orlando, Florida, United States
Pfizer Investigational Site
Atlanta, Georgia, United States
Pfizer Investigational Site
Marietta, Georgia, United States
Pfizer Investigational Site
Overland Park, Kansas, United States
Pfizer Investigational Site
Overland Park, Kansas, United States
Pfizer Investigational Site
Albuquerque, New Mexico, United States
Pfizer Investigational Site
Albuquerque, New Mexico, United States
Pfizer Investigational Site
Cincinnati, Ohio, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A9001141
Identifier Type: -
Identifier Source: org_study_id