Status:
COMPLETED
Clinical Study Assessing a New Scale to Measure Onset of Action in Generalized Anxiety Disorder
Lead Sponsor:
Pfizer
Conditions:
Anxiety Disorders
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The study is to assess the performance characteristics of a new measure to assess onset of efficacy in a GAD patient population.
Eligibility Criteria
Inclusion
- Primary Diagnosis of GAD (DSM IV, 300.02) as established by the clinician using all sources of data including the MINI structured interview
- 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
- Patients with most other current DSM-IV Axis I disorders.
- 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.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2004
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT00715039
Start Date
October 1 2003
End Date
May 1 2004
Last Update
October 3 2008
Active Locations (15)
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1
Pfizer Investigational Site
Glendale, California, United States, 91206
2
Pfizer Investigational Site
Northridge, California, United States, 91406
3
Pfizer Investigational Site
Orange, California, United States, 92868
4
Pfizer Investigational Site
San Diego, California, United States, 92105