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A 10-Week Study Evaluating the Efficacy And Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A 10-Week Study Evaluating the Efficacy And Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder

A Phase 3, Randomized, Double-Blind, Placebo Controlled, Parallel Group, 10-Week Study Evaluating the Efficacy And Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder

NCT00542685•Pfizer

View on ClinicalTrials.gov

Summary

This study will evaluate the efficacy and safety of PD 0332334 for the treatment of generalized anxiety disorder.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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 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.

Locations (43)

Pfizer Investigational Site

Beverly Hills, California, United States

Pfizer Investigational Site

Encino, California, United States

Pfizer Investigational Site

National City, California, United States

Pfizer Investigational Site

Newport Beach, California, United States

Pfizer Investigational Site

San Diego, California, United States

Pfizer Investigational Site

Sherman Oaks, California, United States

Pfizer Investigational Site

Farmington, Connecticut, United States

Pfizer Investigational Site

Jacksonville, Florida, United States

Pfizer Investigational Site

Jacksonville, Florida, United States

Pfizer Investigational Site

Orlando, Florida, United States

Key Dates

Start Date

October 1, 2007

Primary Completion Date

December 1, 2008

Completion Date

December 1, 2008

Last Updated

November 16, 2012

Enrollment

551

ACTUAL participants

Conditions

Generalized Anxiety Disorder

Interventions

PD 0332334

DRUG

Placebo

DRUG

PD 0332334

DRUG

PD 0332334

DRUG

Transcranial Alternating Current Stimulation for Generalized Anxiety Disorder and Insomnia: An Open-Label Pilot Study

NCT07429578

Generalized Anxiety Disorder (GAD)Chronic Insomnia

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RECRUITINGNA

Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders

NCT06661460

ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)Specific Phobia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 16, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A 10-Week Study Evaluating the Efficacy And Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder

Inclusion Criteria

Exclusion Criteria

Transcranial Alternating Current Stimulation for Generalized Anxiety Disorder and Insomnia: An Open-Label Pilot Study

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