DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anxiety Disorders

Intervention: lorazepam (Drug); placebo (Drug); paroxetine (Drug)

Phase: N/A

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Primary outcome: 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:

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

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Pfizer Investigational Site, Glendale, California 91206, United States

Pfizer Investigational Site, Northridge, California 91406, United States

Pfizer Investigational Site, Orange, California 92868, United States

Pfizer Investigational Site, San Diego, California 92105, United States

Pfizer Investigational Site, Sherman Oaks, California 91403, United States

Pfizer Investigational Site, Van Nuys, California 91406, United States

Pfizer Investigational Site, Casselberry, Florida 32707, United States

Pfizer Investigational Site, Orlando, Florida 32806, United States

Pfizer Investigational Site, Atlanta, Georgia 30328, United States

Pfizer Investigational Site, Marietta, Georgia 30060, United States

Pfizer Investigational Site, Overland Park, Kansas 66209, United States

Pfizer Investigational Site, Overland Park, Kansas 66211, United States

Pfizer Investigational Site, Albuquerque, New Mexico 87102, United States

Pfizer Investigational Site, Albuquerque, New Mexico 87104, United States

Pfizer Investigational Site, Cincinnati, Ohio 45267-0559, United States

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: October 2003
Last updated: October 1, 2008

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017