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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00715039

Collaborator

(none)

169

Enrollment

Locations

Arms

Duration (Months)

11.3

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorders	Drug: lorazepam Drug: placebo Drug: paroxetine	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

169 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Basic Science

Official Title:

A 4-Week, Double-Blind, Randomized, Multicenter, Fixed Dose, Placebo-Controlled, Parallel Group Study of Lorazepam and Paroxetine in Patients With Generalized Anxiety Disorder: Assessment of a New Instrument Intended to Capture Rapid Onset

Study Start Date :

Oct 1, 2003

Actual Study Completion Date :

May 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: lorazepam	Drug: 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 Other Names: Ativan
Placebo Comparator: placebo	Drug: placebo placebo p.o. t.i.d. for 28 days; placebo matching lorazepam and paroxetine
Active Comparator: paroxetine	Drug: paroxetine 20mg p.o. daily for 28 days; and matching placebo twice a day to maintain blind Other Names: Paxil

Arm

Intervention/Treatment

Active Comparator: lorazepam

Drug: 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

Other Names:

Ativan

Placebo Comparator: placebo

Drug: placebo

placebo p.o. t.i.d. for 28 days; placebo matching lorazepam and paroxetine

Active Comparator: paroxetine

Drug: paroxetine

20mg p.o. daily for 28 days; and matching placebo twice a day to maintain blind

Other Names:

Paxil

Outcome Measures

Primary Outcome Measures

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

CGIC at endpoint (LOCF) [endpoint]
PGIC at endpoint (LOCF) [endpoint]
Q-LES-Q change from baseline to endpoint (LOCF) [baseline, endpoint]
SF-36v2 Mental Health change from baseline to endpoint (LOCF) [baseline, endpoint]
HADS-A change from baseline to endpoint (LOCF) [baseline, endpoint]
HADS-D 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]
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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Pfizer Investigational Site	Sherman Oaks	California	United States	91403
6	Pfizer Investigational Site	Van Nuys	California	United States	91406
7	Pfizer Investigational Site	Casselberry	Florida	United States	32707
8	Pfizer Investigational Site	Orlando	Florida	United States	32806
9	Pfizer Investigational Site	Atlanta	Georgia	United States	30328
10	Pfizer Investigational Site	Marietta	Georgia	United States	30060
11	Pfizer Investigational Site	Overland Park	Kansas	United States	66209
12	Pfizer Investigational Site	Overland Park	Kansas	United States	66211
13	Pfizer Investigational Site	Albuquerque	New Mexico	United States	87102
14	Pfizer Investigational Site	Albuquerque	New Mexico	United States	87104
15	Pfizer Investigational Site	Cincinnati	Ohio	United States	45267-0559