A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (1)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Generalized Anxiety Disorder

In brief

This is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects, ages from 18 to 65, with generalized anxiety disorder.

Key facts

Study ID

NCT00658008

Run by

Pfizer

People needed

501

Starts

2008-04-01

Expected to finish

2009-03-01

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 diagnosis: 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 — Costa Mesa, California, United States
• Pfizer Investigational Site — Pasadena, California, United States
• Pfizer Investigational Site — Redlands, California, United States
• Pfizer Investigational Site — Denver, Colorado, United States
• Pfizer Investigational Site — Norwich, Connecticut, United States
• Pfizer Investigational Site — Altamonte Springs, Florida, United States
• Pfizer Investigational Site — Maitland, Florida, United States
• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — South Miami, Florida, United States
• Pfizer Investigational Site — Terre Haute, Indiana, United States
• Pfizer Investigational Site — Overland Park, Kansas, United States
• Pfizer Investigational Site — Topeka, Kansas, United States
• Pfizer Investigational Site — Shreveport, Louisiana, United States
• Pfizer Investigational Site — Baltimore, Maryland, United States
• Pfizer Investigational Site — Boston, Massachusetts, United States
• Pfizer Investigational Site — Saint Charles, Missouri, United States
• Pfizer Investigational Site — Las Vegas, Nevada, United States
• Pfizer Investigational Site — Clementon, New Jersey, United States
• Pfizer Investigational Site — Willingboro, New Jersey, United States
• Pfizer Investigational Site — Albuquerque, New Mexico, United States
• Pfizer Investigational Site — Brooklyn, New York, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — The Bronx, New York, United States
• Pfizer Investigational Site — Litchfield Park, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.