Overview

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

Status:
Terminated
Trial end date:
2009-04-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Treatments:
Paroxetine
Criteria
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 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 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.