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
1 other identifier
interventional
222
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2005
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 15, 2009
CompletedFirst Posted
Study publicly available on registry
June 16, 2009
CompletedFebruary 19, 2010
February 1, 2010
8 months
June 15, 2009
February 17, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
HAM-A Total Score
4 weeks
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Study Arms (4)
PD 0332334 250 mg
EXPERIMENTALPD 0332334 100 mg
EXPERIMENTALplacebo
PLACEBO COMPARATORAlprazolam extended release
ACTIVE COMPARATORInterventions
1 mg capsule, BID for 4 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 15, 2009
First Posted
June 16, 2009
Study Start
November 1, 2005
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
February 19, 2010
Record last verified: 2010-02