Status:
TERMINATED
A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder (3)
Lead Sponsor:
Pfizer
Conditions:
Generalized Anxiety Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects ages 18 and older with generalized anxiety disorder.
Detailed Description
Termination reason: On February 23rd 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not base...
Eligibility Criteria
Inclusion
- Diagnosis of GAD (Diagnostic and Statistical Manual-IV \[DSM-IV\], 300.02) as established by the clinician (psychiatrist or licensed clinical psychologist) who has interviewed the subject using all sources of data including the Mini International Neuropsychiatric Interview (MINI) for DSM-IV Axis I disorders and other clinical information. Subjects with specific phobia(s) (as defined in DSM-IV) or dysthymic disorder will be allowed in the study.
- Subjects must have a HAM-A total score \>/= 20 at the screening (V1) and randomization (V2) visits. Subjects must also have a Covi Anxiety Scale score of \>/= 9 and a Raskin Depression Scale score \</= 7 at the Screening (V1) visit to ensure predominance of anxiety symptoms over depression symptoms.
Exclusion
- Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, neurologic, active infections, immunological, or allergic disease (including drug allergies).
- Any of the following current (within the past 6 months through the present) DSM-IV Axis I diagnoses: Major depressive disorder; Obsessive compulsive disorder; Panic disorder; Agoraphobia; Posttraumatic stress disorder; Anorexia; Bulimia; Caffeine-induced anxiety disorder; Alcohol or substance abuse or dependence unless in full remission for at least 6 months; Social anxiety disorder.
- Any of the following past or current DSM-IV Axis I diagnoses: Schizophrenia; Psychotic disorder; Delirium, dementia, amnestic and other clinically significant cognitive disorders; Bipolar or schizoaffective disorder; Cyclothymic disorder; Dissociative disorders.
- Antisocial or borderline personality disorder.
- Serious suicidal risk per the clinical investigator's judgment.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
286 Patients enrolled
Trial Details
Trial ID
NCT00658762
Start Date
May 1 2008
End Date
April 1 2009
Last Update
November 16 2012
Active Locations (28)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35226
2
Pfizer Investigational Site
Glendale, California, United States, 91206
3
Pfizer Investigational Site
Orange, California, United States, 92868
4
Pfizer Investigational Site
Temecula, California, United States, 92591