A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 5-Week Trial To Assess The Efficacy And Safety Of PD 0332334 Compared To Placebo And Alprazolam Extended-Release In Patients With Generalized Anxiety Disorder

Pfizer0 sites222 target enrollmentNovember 2005

ConditionsGeneralized Anxiety Disorder

InterventionsPD 0332334 placebo Alprazolam extended release

DrugsPD 0332334 placebo Alprazolam extended release

Overview

Phase: Phase 2
Intervention: PD 0332334
Conditions: Generalized Anxiety Disorder
Sponsor: Pfizer
Enrollment: 222
Primary Endpoint: HAM-A Total Score
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of PD 0332334 compared to placebo in the treatment of Generalized Anxiety Disorder in an adult population

Registry

clinicaltrials.gov

Start Date

November 2005

End Date

July 2006

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Eligibility Criteria

Inclusion Criteria

•Healthy males or females with a diagnosis of Generalized Anxiety Disorder (GAD) (Diagnostic and Statistical Manual-IV \[DSM-IV\], 300.02).
•HAM-A Total Score ≥20 and item #1 on the HAM-D (depressed mood score) ≤2 at both Screening and Baseline/Randomization.

Exclusion Criteria

•Current diagnoses (within the 6 months) of Major Depressive Disorder; Obsessive Compulsive Disorder; Panic Disorder; Posttraumatic Stress Disorder; Anorexia; Bulimia; Caffeine-induced anxiety disorder;
•Any of the following past or current diagnoses: Schizophrenia; Psychotic Disorder; Delirium, Dementia, Bipolar or Schizoaffective Disorder; Cyclothymic Disorder; Dissociative Disorders; Antisocial or borderline personality disorder
•Current use of psychotropic medications (i.e., drugs normally prescribed for depression, mania, anxiety, insomnia, or psychosis) that could not be discontinued 2 weeks prior to dosing.

Arms & Interventions

PD 0332334 100 mg

Intervention: PD 0332334

PD 0332334 250 mg

Intervention: PD 0332334

placebo

Intervention: placebo

Alprazolam extended release

Intervention: Alprazolam extended release

Outcomes

Primary Outcomes

HAM-A Total Score

Time Frame: 4 weeks

Secondary Outcomes

HAM-A total score at week 1, 2 and 4(1. 2. ands 4 weeks)
HAM-A somatic and psychic subscales(1, 2, and 4 weeks)
HAM-A responders(4 weeks)
HAM-A sustained responders(Week 1 through week 4)
DAS-A (daily assessment of symptoms of anxiety) and GA-VAS (VAS scale for global anxiety)(Day 2 through day 7)
CGI-I (Clinical Global Impression of Improvement) and PGI-I (Patient Global Impression of Change)(1 and 4 weeks)
HAM-D total score(1 and 4 weeks)
Sheehan Disability Score (SDS)(4 weeks)
Treatment Satisfaction Questionaire for Medication(4 weeks)