A 5-Week Trial Of PD 0332334 And Alprazolam Extended Release Compared To Placebo In Patients With Generalized Anxiety Disorder

Study 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

Official Title
-----------------
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

Conditions
-----------------
Generalized Anxiety Disorder

Intervention / Treatment
-----------------
* Drug: PD 0332334
* Drug: PD 0332334
* Drug: placebo
* Drug: Alprazolam extended release


Participation Criteria
=================
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.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PD 0332334 250 mg<br> | Drug: PD 0332334<br>* 250 mg capsule, BID for 4 weeks<br>* Other names: imagabalin;|
| Experimental: PD 0332334 100 mg<br> | Drug: PD 0332334<br>* 100 mg capsule, BID for 4 weeks<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* 0 mg capsule, BID for 4 weeks<br>|
| Active Comparator: Alprazolam extended release<br> | Drug: Alprazolam extended release<br>* 1 mg capsule, BID for 4 weeks<br>* Other names: Xanax XR;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAM-A Total Score |  | 4 weeks | 

Secondary Outcome Measures

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