A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder (3)

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 18 and older with generalized anxiety disorder.

Key facts

Study ID

NCT00658762

Run by

Pfizer

People needed

286

Starts

2008-05-01

Expected to finish

2009-04-01

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 — Birmingham, Alabama, United States
• Pfizer Investigational Site — Glendale, California, United States
• Pfizer Investigational Site — Orange, California, United States
• Pfizer Investigational Site — Temecula, California, United States
• Pfizer Investigational Site — Upland, California, United States
• Pfizer Investigational Site — Wildomar, California, United States
• Pfizer Investigational Site — Fort Myers, Florida, United States
• Pfizer Investigational Site — Orange City, Florida, United States
• Pfizer Investigational Site — Atlanta, Georgia, United States
• Pfizer Investigational Site — Marietta, Georgia, United States
• Pfizer Investigational Site — Greenwood, Indiana, United States
• Pfizer Investigational Site — Wichita, Kansas, United States
• Pfizer Investigational Site — Omaha, Nebraska, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — Syracuse, New York, United States
• Pfizer Investigational Site — Beachwood, Ohio, United States
• Pfizer Investigational Site — Cincinnati, Ohio, United States
• Pfizer Investigational Site — Cleveland, Ohio, United States
• Pfizer Investigational Site — Oklahoma City, Oklahoma, United States
• Pfizer Investigational Site — Oklahoma City, Oklahoma, United States
• Pfizer Investigational Site — Salem, Oregon, United States
• Pfizer Investigational Site — Media, Pennsylvania, United States
• Pfizer Investigational Site — Norristown, Pennsylvania, United States
• Pfizer Investigational Site — Dallas, Texas, United States
• Pfizer Investigational Site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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