A 10-Week Study Evaluating the Efficacy And Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder

Completed · Phase 3 · Has a placebo group

Conditions studied: Generalized Anxiety Disorder

In brief

This study will evaluate the efficacy and safety of PD 0332334 for the treatment of generalized anxiety disorder.

Key facts

Study ID

NCT00542685

Run by

Pfizer

People needed

551

Starts

2007-10-01

Expected to finish

2008-12-01

Last updated by the study team

2012-11-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Beverly Hills, California, United States
• Pfizer Investigational Site — Encino, California, United States
• Pfizer Investigational Site — National City, California, United States
• Pfizer Investigational Site — Newport Beach, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — Sherman Oaks, California, United States
• Pfizer Investigational Site — Farmington, Connecticut, United States
• Pfizer Investigational Site — Jacksonville, Florida, United States
• Pfizer Investigational Site — Jacksonville, Florida, United States
• Pfizer Investigational Site — Orlando, Florida, United States
• Pfizer Investigational Site — Tampa, Florida, United States
• Pfizer Investigational Site — West Palm Beach, Florida, United States
• Pfizer Investigational Site — Atlanta, Georgia, United States
• Pfizer Investigational Site — Atlanta, Georgia, United States
• Pfizer Investigational Site — Marietta, Georgia, United States
• Pfizer Investigational Site — Libertyville, Illinois, United States
• Pfizer Investigational Site — Schaumburg, Illinois, United States
• Pfizer Investigational Site — Lafayette, Indiana, United States
• Pfizer Investigational Site — Owensboro, Kentucky, United States
• Pfizer Investigational Site — Lake Charles, Louisiana, United States
• Pfizer Investigational Site — Glen Burnie, Maryland, United States
• Pfizer Investigational Site — Rockville, Maryland, United States
• Pfizer Investigational Site — Belmont, Massachusetts, United States
• Pfizer Investigational Site — Fall River, Massachusetts, United States
• Pfizer Investigational Site — Farmington Hills, Michigan, United States

Full record on ClinicalTrials.gov

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