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

Primary Purpose

Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
lorazepam
placebo
paroxetine
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Anxiety Disorders focused on measuring generalized anxiety disorder, onset of efficacy, Daily Assessment of Symptoms-Anxiety (DAS-A), Methods

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

lorazepam

placebo

paroxetine

Arm Description

Outcomes

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 11, 2008
Last Updated
October 1, 2008
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00715039
Brief Title
Clinical Study Assessing a New Scale to Measure Onset of Action in Generalized Anxiety Disorder
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 Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
generalized anxiety disorder, onset of efficacy, Daily Assessment of Symptoms-Anxiety (DAS-A), Methods

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
169 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lorazepam
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
paroxetine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
lorazepam
Other Intervention Name(s)
Ativan
Intervention Description
1.0 mg p.o. three times a day for three days, then 1.5mg p.o. three times a day for 25 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo p.o. t.i.d. for 28 days; placebo matching lorazepam and paroxetine
Intervention Type
Drug
Intervention Name(s)
paroxetine
Other Intervention Name(s)
Paxil
Intervention Description
20mg p.o. daily for 28 days; and matching placebo twice a day to maintain blind
Primary Outcome Measure Information:
Title
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.
Time Frame
baseline, days 2 through 7
Secondary Outcome Measure Information:
Title
CGIC at endpoint (LOCF)
Time Frame
endpoint
Title
PGIC at endpoint (LOCF)
Time Frame
endpoint
Title
Q-LES-Q change from baseline to endpoint (LOCF)
Time Frame
baseline, endpoint
Title
SF-36v2 Mental Health change from baseline to endpoint (LOCF)
Time Frame
baseline, endpoint
Title
HADS-A change from baseline to endpoint (LOCF)
Time Frame
baseline, endpoint
Title
HADS-D change from baseline to endpoint (LOCF)
Time Frame
baseline, endpoint
Title
Change from baseline to endpoint (Weeks 1, 2, 4, and 5) in the HAM-A total score.
Time Frame
baseline and weeks 1,2,4, and 5
Title
Change from baseline to daily time point (Study Days 2 through 7) on the DAS-A.
Time Frame
baseline and days 2 through 7
Title
DAS-A change from baseline to endpoint (LOCF)
Time Frame
baseline to endpoint
Title
DAS-A 30% and 50% improvement at endpoint;
Time Frame
endpoint
Title
DAS-A 30% sustained improvement beginning at week 1
Time Frame
baseline, week1, 2,4,
Title
HAM-A 30% sustained improvement beginning at week 1
Time Frame
baseline, weeks 1,2,4
Title
HAM-A 30% and 50% improvement at endpoint
Time Frame
endpoint
Title
GA-VAS average change from baseline over the first 6 days
Time Frame
baseline, days 2-7
Title
Change from baseline to daily time point on the GA-VAS(study days 2 through 7)
Time Frame
baseline, days 2-7
Title
GA-VAS change from baseline to endpoint
Time Frame
aseline, endpoint
Title
GA-VAS sustained 30% improvement beginning at week 1
Time Frame
baseline, weeks 1,2,4
Title
GA-VAS 30% and 50% improvement at endpoint
Time Frame
endpoint

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Pfizer Investigational Site
City
Northridge
State/Province
California
ZIP/Postal Code
91406
Country
United States
Facility Name
Pfizer Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92105
Country
United States
Facility Name
Pfizer Investigational Site
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Pfizer Investigational Site
City
Van Nuys
State/Province
California
ZIP/Postal Code
91406
Country
United States
Facility Name
Pfizer Investigational Site
City
Casselberry
State/Province
Florida
ZIP/Postal Code
32707
Country
United States
Facility Name
Pfizer Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Pfizer Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Pfizer Investigational Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Pfizer Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
Pfizer Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Pfizer Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Pfizer Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87104
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0559
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9001141&StudyName=Clinical%20study%20assessing%20a%20new%20scale%20to%20measure%20onset%20of%20action%20in%20Generalized%20Anxiety%20Disorder
Description
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Clinical Study Assessing a New Scale to Measure Onset of Action in Generalized Anxiety Disorder

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