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

Anxiety Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00715039
• Other study ID #: A9001141
• Status: Completed
• Phase: N/A
• First received: July 11, 2008
• Last updated: October 1, 2008
• Start date: October 2003
• Est. completion date: May 2004

Study information

• Verified date: October 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• 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
• placebo
placebo p.o. t.i.d. for 28 days; placebo matching lorazepam and paroxetine
• paroxetine
20mg p.o. daily for 28 days; and matching placebo twice a day to maintain blind

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Casselberry	Florida
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Glendale	California
United States	Pfizer Investigational Site	Marietta	Georgia
United States	Pfizer Investigational Site	Northridge	California
United States	Pfizer Investigational Site	Orange	California
United States	Pfizer Investigational Site	Orlando	Florida
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	Sherman Oaks	California
United States	Pfizer Investigational Site	Van Nuys	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		baseline, days 2 through 7	No
Secondary	CGIC at endpoint (LOCF)		endpoint	No
Secondary	PGIC at endpoint (LOCF)		endpoint	No
Secondary	Q-LES-Q change from baseline to endpoint (LOCF)		baseline, endpoint	No
Secondary	SF-36v2 Mental Health change from baseline to endpoint (LOCF)		baseline, endpoint	No
Secondary	HADS-A change from baseline to endpoint (LOCF)		baseline, endpoint	No
Secondary	HADS-D change from baseline to endpoint (LOCF)		baseline, endpoint	No
Secondary	Change from baseline to endpoint (Weeks 1, 2, 4, and 5) in the HAM-A total score.		baseline and weeks 1,2,4, and 5	No
Secondary	Change from baseline to daily time point (Study Days 2 through 7) on the DAS-A.		baseline and days 2 through 7	No
Secondary	DAS-A change from baseline to endpoint (LOCF)		baseline to endpoint	No
Secondary	DAS-A 30% and 50% improvement at endpoint;		endpoint	No
Secondary	DAS-A 30% sustained improvement beginning at week 1		baseline, week1, 2,4,	No
Secondary	HAM-A 30% sustained improvement beginning at week 1		baseline, weeks 1,2,4	No
Secondary	HAM-A 30% and 50% improvement at endpoint		endpoint	No
Secondary	GA-VAS average change from baseline over the first 6 days		baseline, days 2-7	No
Secondary	Change from baseline to daily time point on the GA-VAS(study days 2 through 7)		baseline, days 2-7	No
Secondary	GA-VAS change from baseline to endpoint		aseline, endpoint	No
Secondary	GA-VAS sustained 30% improvement beginning at week 1		baseline, weeks 1,2,4	No
Secondary	GA-VAS 30% and 50% improvement at endpoint		endpoint	No

External Links

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