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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00921063

Enrollment

222

Registered

2009-06-16

Start date

2005-11-30

Completion date

2006-07-31

Last updated

2010-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Anxiety Disorder

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

Interventions

DRUGPD 0332334

250 mg capsule, BID for 4 weeks

DRUGplacebo

0 mg capsule, BID for 4 weeks

DRUGAlprazolam extended release

1 mg capsule, BID for 4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
HAM-A Total Score	4 weeks

Secondary

Measure	Time frame
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
HAM-A total score at week 1, 2 and 4	1. 2. ands 4 weeks
HAM-D total score	1 and 4 weeks
Sheehan Disability Score (SDS)	4 weeks
Treatment Satisfaction Questionaire for Medication	4 weeks
CGI-I (Clinical Global Impression of Improvement) and PGI-I (Patient Global Impression of Change)	1 and 4 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026