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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Page 1 of 4 (15 locations)

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