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

Not Applicable

Completed

• Conditions: Anxiety Disorders
• Interventions: Drug: placebo; Drug: paroxetine; Drug: lorazepam

• Registration Number: NCT00715039
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Study Completion: 2004-05
• Study First Submitted: 2008-07-11
• Study First Submitted QC: 2008-07-14
• Study First Posted: 2008-07-15
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-01
• Last Update Posted: 2008-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
paroxetine	paroxetine	-
lorazepam	lorazepam	-

Primary Outcome Measures

Name	Time	Method
Average change from baseline over the first 6 days of treatment assessment (Study Days 2 through 7) on the Daily Assessment of Symptoms - Anxiety (DAS-A) questionnaire.	baseline, days 2 through 7

Secondary Outcome Measures

Name	Time	Method
CGIC at endpoint (LOCF)	endpoint
PGIC at endpoint (LOCF)	endpoint
HADS-A change from baseline to endpoint (LOCF)	baseline, endpoint
HADS-D change from baseline to endpoint (LOCF)	baseline, endpoint
SF-36v2 Mental Health change from baseline to endpoint (LOCF)	baseline, endpoint
Change from baseline to daily time point (Study Days 2 through 7) on the DAS-A.	baseline and days 2 through 7
DAS-A change from baseline to endpoint (LOCF)	baseline to endpoint
Q-LES-Q change from baseline to endpoint (LOCF)	baseline, endpoint
Change from baseline to endpoint (Weeks 1, 2, 4, and 5) in the HAM-A total score.	baseline and weeks 1,2,4, and 5
DAS-A 30% and 50% improvement at endpoint;	endpoint
DAS-A 30% sustained improvement beginning at week 1	baseline, week1, 2,4,
HAM-A 30% sustained improvement beginning at week 1	baseline, weeks 1,2,4
HAM-A 30% and 50% improvement at endpoint	endpoint
GA-VAS average change from baseline over the first 6 days	baseline, days 2-7
Change from baseline to daily time point on the GA-VAS(study days 2 through 7)	baseline, days 2-7
GA-VAS change from baseline to endpoint	aseline, endpoint
GA-VAS sustained 30% improvement beginning at week 1	baseline, weeks 1,2,4
GA-VAS 30% and 50% improvement at endpoint	endpoint

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Cincinnati, Ohio, United States