A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, 10-WEEK, PLACEBO CONTROLLED FIXED DOSE STUDY OF PD 0332334 AND PAROXETINE EVALUATING THE EFFICACY AND SAFETY OF PD 0332334 FOR THE TREATMENT OF GENERALIZED ANXIETY DISORDER

Pfizer Inc, 235 East 42nd Street, New York, NY 100170 sites658 target enrollmentJune 3, 2008

ConditionsGeneralized Anxiety Disorder (GAD)MedDRA version: 9.1Level: LLTClassification code 10018105Term: Generalized anxiety disorder

DrugsSeroxat

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Generalized Anxiety Disorder (GAD)
Sponsor: Pfizer Inc, 235 East 42nd Street, New York, NY 10017
Enrollment: 658
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 3, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

Eligibility Criteria

Inclusion Criteria

•1\. 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.
•2\. 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.
•3\. Otherwise healthy men or nonpregnant, nonlactating women (women must be using a hormonal or barrier method of contraception or be postmenopausal or surgically sterilized). Healthy is defined as no other clinically relevant abnormalities identified by a detailed medical history, full physical examination including sitting blood pressure (BP) and heart rate measurement, 12\-lead ECG, and clinical laboratory tests.
•4\. Age 18 to 65 years, inclusive.
•5\. All women must have negative pregnancy tests at the Screening (V1\) and Randomization (V2\) visits.
•6\. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
•7\. Subjects who are willing and able to comply with scheduled visits, treatment plan,
•laboratory tests, and other study procedures.
•Are the trial subjects under 18? no
•Number of subjects for this age range:

Exclusion Criteria

•1\. 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).
•2\. 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.
•3\. 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.
•4\. Antisocial or borderline personality disorder.
•5\. Serious suicidal risk per the clinical investigator’s judgment. (Note: The Suicidality module of the MINI diagnostic interview and the C\-SSRS should be used as aids to the assessment of suicidality, but do not replace overall clinical judgement in determination of suicidal risk).
•6\. Current use of psychotropic medications (ie, drugs normally prescribed for depression, mania, anxiety, insomnia, or psychosis) that cannot be discontinued 2 weeks prior to randomization. Fluoxetine is prohibited within 5 weeks of randomization. In the event of inadvertent administration of psychotropic medications during the 2 weeks prior to randomization, continued eligibility will be assessed on a case by case basis by the investigator and the medical monitor
•7\. Use of drugs, supplements, prescription or nonprescription, or food that have psychoactive properties. In the event of inadvertent use of such products during the 2 weeks prior to randomization, continued eligibility will be assessed on a case by case basis by the investigator and the medical monitor. In addition, following a discussion of the individual case between medical monitor and the investigator, the medical monitor may allow minimal anxiolytic medication (for example a benzodiazepine) use for subjects who experience significant anxiety during the final week of the study (Days 64\-71\).
•8\. Subjects who have been treated with monoamine oxidase inhibitors in the 14 days prior to the baseline visit.