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

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

Overview[ - collapse ][ - ]

Purpose	The study is to assess the performance characteristics of a new measure to assess onset of efficacy in a GAD patient population.
Condition	Anxiety Disorders
Intervention	Drug: lorazepam Drug: placebo Drug: paroxetine
Phase	N/A
Sponsor	Pfizer
Responsible Party	Pfizer
ClinicalTrials.gov Identifier	NCT00715039
First Received	July 11, 2008
Last Updated	October 1, 2008
Last verified	October 2008

Tracking Information[ + expand ][ + ]

First Received Date	July 11, 2008
Last Updated Date	October 1, 2008
Start Date	October 2003
Estimated Primary Completion Date	May 2004
Current 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. [Time Frame: baseline, days 2 through 7] [Designated as safety issue: No]
Current Secondary Outcome Measures	CGIC at endpoint (LOCF) [Time Frame: endpoint] [Designated as safety issue: No] PGIC at endpoint (LOCF) [Time Frame: endpoint] [Designated as safety issue: No] Q-LES-Q change from baseline to endpoint (LOCF) [Time Frame: baseline, endpoint] [Designated as safety issue: No] SF-36v2 Mental Health change from baseline to endpoint (LOCF) [Time Frame: baseline, endpoint] [Designated as safety issue: No] HADS-A change from baseline to endpoint (LOCF) [Time Frame: baseline, endpoint] [Designated as safety issue: No] HADS-D change from baseline to endpoint (LOCF) [Time Frame: baseline, endpoint] [Designated as safety issue: No] 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] [Designated as safety issue: No] Change from baseline to daily time point (Study Days 2 through 7) on the DAS-A. [Time Frame: baseline and days 2 through 7] [Designated as safety issue: No] DAS-A change from baseline to endpoint (LOCF) [Time Frame: baseline to endpoint] [Designated as safety issue: No] DAS-A 30% and 50% improvement at endpoint; [Time Frame: endpoint] [Designated as safety issue: No] DAS-A 30% sustained improvement beginning at week 1 [Time Frame: baseline, week1, 2,4,] [Designated as safety issue: No] HAM-A 30% sustained improvement beginning at week 1 [Time Frame: baseline, weeks 1,2,4] [Designated as safety issue: No] HAM-A 30% and 50% improvement at endpoint [Time Frame: endpoint] [Designated as safety issue: No] GA-VAS average change from baseline over the first 6 days [Time Frame: baseline, days 2-7] [Designated as safety issue: No] Change from baseline to daily time point on the GA-VAS(study days 2 through 7) [Time Frame: baseline, days 2-7] [Designated as safety issue: No] GA-VAS change from baseline to endpoint [Time Frame: aseline, endpoint] [Designated as safety issue: No] GA-VAS sustained 30% improvement beginning at week 1 [Time Frame: baseline, weeks 1,2,4] [Designated as safety issue: No] GA-VAS 30% and 50% improvement at endpoint [Time Frame: endpoint] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

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
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 Provided
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
Condition	Anxiety Disorders
Intervention	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: AtivanDrug: placebo placebo p.o. t.i.d. for 28 days; placebo matching lorazepam and paroxetine Drug: paroxetine 20mg p.o. daily for 28 days; and matching placebo twice a day to maintain blind Other Names: Paxil
Study Arm (s)	Active Comparator: lorazepam Placebo Comparator: placebo Active Comparator: paroxetine

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	169
Estimated Completion Date	May 2004
Estimated Primary Completion Date	Not Provided
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.
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00715039
Other Study ID Numbers	A9001141
Has Data Monitoring Committee	No
Information Provided By	Pfizer
Study Sponsor	Pfizer
Collaborators	Not Provided
Investigators	Study Director: Pfizer CT.gov Call Center Pfizer
Verification Date	October 2008

Locations[ + expand ][ + ]

Pfizer Investigational Site	Glendale, California, United States, 91206
Pfizer Investigational Site	Northridge, California, United States, 91406
Pfizer Investigational Site	Orange, California, United States, 92868
Pfizer Investigational Site	San Diego, California, United States, 92105
Pfizer Investigational Site	Sherman Oaks, California, United States, 91403
Pfizer Investigational Site	Van Nuys, California, United States, 91406
Pfizer Investigational Site	Casselberry, Florida, United States, 32707
Pfizer Investigational Site	Orlando, Florida, United States, 32806
Pfizer Investigational Site	Atlanta, Georgia, United States, 30328
Pfizer Investigational Site	Marietta, Georgia, United States, 30060
Pfizer Investigational Site	Overland Park, Kansas, United States, 66209
Pfizer Investigational Site	Overland Park, Kansas, United States, 66211
Pfizer Investigational Site	Albuquerque, New Mexico, United States, 87102
Pfizer Investigational Site	Albuquerque, New Mexico, United States, 87104
Pfizer Investigational Site	Cincinnati, Ohio, United States, 45267-0559