Clinical Study Assessing a New Scale to Measure Onset of Action in Generalized Anxiety Disorder

• Status: Completed
• Trial end date: 2004-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is to assess the performance characteristics of a new measure to assess onset of efficacy in a GAD patient population.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Lorazepam; Paroxetine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.