Anxiety Disorders
Conditions
Keywords
generalized anxiety disorder, onset of efficacy, Daily Assessment of Symptoms-Anxiety (DAS-A), Methods
Brief summary
The study is to assess the performance characteristics of a new measure to assess onset of efficacy in a GAD patient population.
Interventions
DRUGlorazepam
1.0 mg p.o. three times a day for three days, then 1.5mg p.o. three times a day for 25 days
DRUGplacebo
placebo p.o. t.i.d. for 28 days; placebo matching lorazepam and paroxetine
DRUGparoxetine
20mg p.o. daily for 28 days; and matching placebo twice a day to maintain blind
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| CGIC at endpoint (LOCF) | 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 |
| DAS-A 30% and 50% improvement at endpoint; | endpoint |
Countries
United States
Outcome results
None listed