• The efficacy of PD 0332334 in the treatment of GAD will be measured by the change in the Hamilton Anxiety Rating Scale (HAM-A) total scores from baseline observed following 8 weeks of double-blind treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• The safety and tolerability of PD 0332334 in subjects with GAD will be monitored in this study [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

• Worsening and improvement from baseline to week 8 on the changes in the Sexual Functioning Questionnaire (CSFQ) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Response rate on the patient-rated PGI-C at week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Change from baseline to week 8 on the Sheehan Disability Scale subscales [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Change from baseline in the somatic subscale score of the HAM-A (items 7 - 13) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Response rate on the HAM-A at week 1 and week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Response rate on the clinician-rated CGI-I ate week 1 and week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in the psychic subscale score of the HAM A (Items 1- 6 and 14) at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Problems Index II [ Time Frame: 1 week ] [ Designated as safety issue: No ]
• Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Problems Index II [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Change from baseline in the HAM-A total score at weeks 1, 2, 4, and 6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
• Change from baseline in the 17-item HAM-D total score at weeks 1, 2, 4, and 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale subscales [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Remission rate based on the HAM A at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Change from baseline in CGI-S at week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Change from baseline to week 8 in the QLesQ General Activity Score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• 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) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
• Change from Baseline to Days 2 8 and Weeks 2, 4, 6, 8 on the DAS A (total score) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Change from baseline to week 8 on the Sheehan Disability Scale (SDS) total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Change from baseline to Days 2-8 and weeks 2, 4, 6 and 8 on the GA-VAS (diary) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Average (across the week 1, 2, 4, 6 and 8 visits) HAM-A change from baseline score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

• Average (across the week 1, 2, 4, 6 and 8 visits) HAM-A change from baseline score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Change from baseline in the HAM-A total score at weeks 1, 2, 4, and 6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
• Change from baseline in the somatic subscale score of the HAM-A (items 7 - 13) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Change from Baseline in the psychic subscale score of the HAM A (Items 1- 6 and 14) at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Response rate on the patient-rated PGI-C at week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Change from baseline to week 8 in the QLesQ General Activity Score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• 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) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
• Change from Baseline to Days 2 8 and Weeks 2, 4, 6, 8 on the DAS A (total score) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Problems Index II [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Worsening and improvement from baseline to week 8 on the changes in the Sexual Functioning Questionnaire (CSFQ) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Change from baseline to week 8 on the Sheehan Disability Scale subscales [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale subscales [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Change from baseline to week 8 on the Sheehan Disability Scale (SDS) total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Response rate on the HAM-A at week 1 and week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Problems Index II [ Time Frame: 1 week ] [ Designated as safety issue: No ]
• Change from baseline in the 17-item HAM-D total score at weeks 1, 2, 4, and 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Change from baseline in CGI-S at week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Change from baseline to Days 2-8 and weeks 2, 4, 6 and 8 on the GA-VAS (diary) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Remission rate based on the HAM A at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Response rate on the clinician-rated CGI-I ate week 1 and week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

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.

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 based on any safety concerns.

• Drug: PD 0332334
• Drug: Paroxetine
• Drug: Placebo

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.