Status:
COMPLETED
A 5-Week Trial Of PD 0332334 And Alprazolam Extended Release Compared To Placebo In Patients With Generalized Anxiety Disorder
Lead Sponsor:
Pfizer
Conditions:
Generalized Anxiety Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT00921063
Start Date
November 1 2005
End Date
July 1 2006
Last Update
February 19 2010
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