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

Pfizer

Status: Completed

Conditions: Anxiety Disorders

Treatments: Drug: placebo; Drug: lorazepam; Drug: paroxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00715039

A9001141

Details and patient eligibility

About

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

Enrollment: 169 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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169 participants in 3 patient groups, including a placebo group

lorazepam

Active Comparator group

Treatment:

Drug: lorazepam

placebo

Placebo Comparator group

Treatment:

Drug: placebo

paroxetine

Active Comparator group

Treatment:

Drug: paroxetine