Clinical trial NCT00715039: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Keywords: generalized anxiety disorder
onset of efficacy
Daily Assessment of Symptoms-Anxiety (DAS-A)
Methods
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-07-15
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


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.

Primary outcomes:
measure: 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.
timeFrame: baseline, days 2 through 7
Secondary outcomes:
measure: CGIC at endpoint (LOCF)
timeFrame: endpoint
measure: PGIC at endpoint (LOCF)
timeFrame: endpoint
measure: Q-LES-Q change from baseline to endpoint (LOCF)
timeFrame: baseline, endpoint
measure: SF-36v2 Mental Health change from baseline to endpoint (LOCF)
timeFrame: baseline, endpoint
measure: HADS-A change from baseline to endpoint (LOCF)
timeFrame: baseline, endpoint
measure: HADS-D change from baseline to endpoint (LOCF)
timeFrame: baseline, endpoint
measure: Change from baseline to endpoint (Weeks 1, 2, 4, and 5) in the HAM-A total score.
timeFrame: baseline and weeks 1,2,4, and 5
measure: Change from baseline to daily time point (Study Days 2 through 7) on the DAS-A.
timeFrame: baseline and days 2 through 7
measure: DAS-A change from baseline to endpoint (LOCF)
timeFrame: baseline to endpoint
measure: DAS-A 30% and 50% improvement at endpoint;
timeFrame: endpoint
measure: DAS-A 30% sustained improvement beginning at week 1
timeFrame: baseline, week1, 2,4,
measure: HAM-A 30% sustained improvement beginning at week 1
timeFrame: baseline, weeks 1,2,4
measure: HAM-A 30% and 50% improvement at endpoint
timeFrame: endpoint
measure: GA-VAS average change from baseline over the first 6 days
timeFrame: baseline, days 2-7
measure: Change from baseline to daily time point on the GA-VAS(study days 2 through 7)
timeFrame: baseline, days 2-7
measure: GA-VAS change from baseline to endpoint
timeFrame: aseline, endpoint
measure: GA-VAS sustained 30% improvement beginning at week 1
timeFrame: baseline, weeks 1,2,4
measure: GA-VAS 30% and 50% improvement at endpoint
timeFrame: endpoint
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: California
city: Northridge
country: United States
facility: Pfizer Investigational Site
state: California
city: Orange
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Sherman Oaks
country: United States
facility: Pfizer Investigational Site
state: California
city: Van Nuys
country: United States
facility: Pfizer Investigational Site
state: California
city: Casselberry
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Marietta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: