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.
Worsening and improvement from baseline to week 8 on the changes in the Sexual Functioning Questionnaire (CSFQ)Response rate on the patient-rated PGI-C at week 8
Change from baseline to week 8 on the Sheehan Disability Scale subscales
Change from baseline in the somatic subscale score of the HAM-A (items 7 - 13)
Response rate on the HAM-A at week 1 and week 8
Response rate on the clinician-rated CGI-I ate week 1 and week 8
Change from Baseline in the psychic subscale score of the HAM A (Items 1- 6 and 14) at Week 8
Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Problems Index II
Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Problems Index II
Change from baseline in the HAM-A total score at weeks 1, 2, 4, and 6
Change from baseline in the 17-item HAM-D total score at weeks 1, 2, 4, and 8
Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale subscales
Remission rate based on the HAM A at Week 8
Change from baseline in CGI-S at week 8
Change from baseline to week 8 in the QLesQ General Activity Score
The "Week 1 Sustained Responder" rate based on the HAM A (where "Week 1 Sustained Responders" are defined as subjects with a 50% or greater improvement from baseline on the HAM A total score at Week 1 that is sustained until the Week 8 visit)
Change from Baseline to Days 2 8 and Weeks 2, 4, 6, 8 on the DAS A (total score)
Change from baseline to week 8 on the Sheehan Disability Scale (SDS) total score
Change from baseline to Days 2-8 and weeks 2, 4, 6 and 8 on the GA-VAS (diary)
Average (across the week 1, 2, 4, 6 and 8 visits) HAM-A change from baseline score
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Inclusion Criteria:
- 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 Criteria:
- 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.
Pfizer Investigational Site, Budapest 1095, Hungary
Pfizer Investigational Site, Budapest 1137, Hungary
Pfizer Investigational Site, Catania 95123, Italy
Pfizer Investigational Site, Torino 10126, Italy
Pfizer Investigational Site, Seoul 135-710, Korea, Republic of
Pfizer Investigational Site, Seoul 138-736, Korea, Republic of
Pfizer Investigational Site, Khotkovo, Moscow region 142601, Russian Federation
Pfizer Investigational Site, Litchfield Park, Arizona 85340, United States
Pfizer Investigational Site, Costa Mesa, California 92626, United States
Pfizer Investigational Site, Pasadena, California 91106, United States
Pfizer Investigational Site, Redlands, California 92374, United States
Pfizer Investigational Site, Denver, Colorado 80239, United States
Pfizer Investigational Site, Norwich, Connecticut 06360, United States
Pfizer Investigational Site, Altamonte Springs, Florida 32701, United States
Pfizer Investigational Site, Maitland, Florida 32751, United States
Pfizer Investigational Site, Miami, Florida 33126, United States
Pfizer Investigational Site, Miami, Florida 33143, United States
Pfizer Investigational Site, South Miami, Florida 33143, United States
Pfizer Investigational Site, Terre Haute, Indiana 47802, United States
Pfizer Investigational Site, Overland Park, Kansas 66212, United States
Pfizer Investigational Site, Topeka, Kansas 66606, United States
Pfizer Investigational Site, Shreveport, Louisiana 71104, United States
Pfizer Investigational Site, Baltimore, Maryland 21208, United States
Pfizer Investigational Site, Boston, Massachusetts 02135, United States
Pfizer Investigational Site, St. Charles, Missouri 63301, United States
Pfizer Investigational Site, Las Vegas, Nevada 89146, United States
Pfizer Investigational Site, Clementon, New Jersey 08021, United States
Pfizer Investigational Site, Willingboro, New Jersey 08046, United States
Pfizer Investigational Site, Albuquerque, New Mexico 87109, United States
Pfizer Investigational Site, Bronx, New York 10454, United States
Pfizer Investigational Site, Bronx, New York 10467, United States
Pfizer Investigational Site, Brooklyn, New York 11235, United States
Pfizer Investigational Site, New York, New York 10023, United States
Pfizer Investigational Site, Raleigh, North Carolina 27607, United States
Pfizer Investigational Site, Toledo, Ohio 43609, United States
Pfizer Investigational Site, Toledo, Ohio 43623, United States
Pfizer Investigational Site, Bethany, Oklahoma 73008, United States
Pfizer Investigational Site, Bala Cynwyd, Pennsylvania 19004, United States
Pfizer Investigational Site, Media, Pennsylvania 19063, United States
Pfizer Investigational Site, Norristown, Pennsylvania 19401, United States
Pfizer Investigational Site, Philadelphia, Pennsylvania 19136, United States
Pfizer Investigational Site, Philadelphia, Pennsylvania 19104, United States
Pfizer Investigational Site, Columbia, South Carolina 29201, United States
Pfizer Investigational Site, Memphis, Tennessee 38117, United States
Pfizer Investigational Site, Austin, Texas 78756, United States
Pfizer Investigational Site, Dallas, Texas 75231, United States
Pfizer Investigational Site, Lake Jackson, Texas 77566, United States
Pfizer Investigational Site, San Antonio, Texas 78229, United States
Pfizer Investigational Site, Burlington, Vermont 05401, United States
Pfizer Investigational Site, Charlottesville, Virginia 22911, United States
Pfizer Investigational Site, Charlottesville, Virginia 22903, United States
Pfizer Investigational Site, Waukesha, Wisconsin 53188-1660, United States