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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00715039
First received: July 11, 2008
Last updated: October 1, 2008
Last verified: October 2008
History of Changes
  Purpose

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


Condition Intervention
Anxiety Disorders
 Drug: lorazepam
Drug: placebo
Drug: paroxetine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by Pfizer:

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 ]

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 ]

Enrollment: 169
Study Start Date: October 2003
Study Completion Date: May 2004
Arms Assigned Interventions
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 Name: 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 Name: Paxil

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00715039

Locations
United States, California
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
United States, Florida
Pfizer Investigational Site
Casselberry, Florida, United States, 32707
Pfizer Investigational Site
Orlando, Florida, United States, 32806
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30328
Pfizer Investigational Site
Marietta, Georgia, United States, 30060
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66209
Pfizer Investigational Site
Overland Park, Kansas, United States, 66211
United States, New Mexico
Pfizer Investigational Site
Albuquerque, New Mexico, United States, 87102
Pfizer Investigational Site
Albuquerque, New Mexico, United States, 87104
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45267-0559
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00715039     History of Changes
Other Study ID Numbers: A9001141
Study First Received: July 11, 2008
Last Updated: October 1, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Pfizer:
generalized anxiety disorder
onset of efficacy
Daily Assessment of Symptoms-Anxiety (DAS-A)
Methods

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Lorazepam
Paroxetine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
 GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents

ClinicalTrials.gov processed this record on May 19, 2013