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

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

Official Title
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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

Conditions
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Anxiety Disorders

Intervention / Treatment
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* Drug: lorazepam
* Drug: placebo
* Drug: paroxetine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: lorazepam<br> | Drug: lorazepam<br>* 1.0 mg p.o. three times a day for three days, then 1.5mg p.o. three times a day for 25 days<br>* Other names: Ativan;|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* placebo p.o. t.i.d. for 28 days; placebo matching lorazepam and paroxetine<br>|
| Active Comparator: paroxetine<br> | Drug: paroxetine<br>* 20mg p.o. daily for 28 days; and matching placebo twice a day to maintain blind<br>* Other names: Paxil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGIC at endpoint (LOCF) |  | endpoint | 
| PGIC at endpoint (LOCF) |  | endpoint | 
| Q-LES-Q change from baseline to endpoint (LOCF) |  | baseline, endpoint | 
| SF-36v2 Mental Health change from baseline to endpoint (LOCF) |  | baseline, endpoint | 
| HADS-A change from baseline to endpoint (LOCF) |  | baseline, endpoint | 
| HADS-D change from baseline to endpoint (LOCF) |  | baseline, endpoint | 
| 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 | 
| Change from baseline to daily time point (Study Days 2 through 7) on the DAS-A. |  | baseline and days 2 through 7 | 
| DAS-A change from baseline to endpoint (LOCF) |  | baseline to endpoint | 
| DAS-A 30% and 50% improvement at endpoint; |  | endpoint | 
| DAS-A 30% sustained improvement beginning at week 1 |  | baseline, week1, 2,4, | 
| HAM-A 30% sustained improvement beginning at week 1 |  | baseline, weeks 1,2,4 | 
| HAM-A 30% and 50% improvement at endpoint |  | endpoint | 
| GA-VAS average change from baseline over the first 6 days |  | baseline, days 2-7 | 
| Change from baseline to daily time point on the GA-VAS(study days 2 through 7) |  | baseline, days 2-7 | 
| GA-VAS change from baseline to endpoint |  | aseline, endpoint | 
| GA-VAS sustained 30% improvement beginning at week 1 |  | baseline, weeks 1,2,4 | 
| GA-VAS 30% and 50% improvement at endpoint |  | endpoint | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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generalized anxiety disorder, onset of efficacy, Daily Assessment of Symptoms-Anxiety (DAS-A), Methods