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A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (1)

NCT ID: NCT00658008

Last Updated: 2012-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

501 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Generalized Anxiety Disorder

Keywords

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PD 0332334 phase 3 pivotal trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PD 0332334 175 mg BID

Group Type EXPERIMENTAL

PD 0332334

Intervention Type DRUG

Capsules, oral, 175 mg BID, 8 weeks with 2 week taper

PD 0332334 225 mg BID

Group Type EXPERIMENTAL

PD 0332334

Intervention Type DRUG

Capsules, oral, 225 mg BID, 8 weeks with 2 week taper

PD 0332334 75 mg BID

Group Type EXPERIMENTAL

PD 0332334

Intervention Type DRUG

Capsules, oral, 75 mg BID, 8 weeks with 2 week taper

Paroxetine 20 mg QD

Group Type ACTIVE_COMPARATOR

Paroxetine

Intervention Type DRUG

Capsules, oral, Paroxetine 20 mg QD, 8 weeks with 2 week taper

Placebo BID

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsules, oral, placebo bid, 8 weeks with 2 week taper

Interventions

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PD 0332334

Capsules, oral, 175 mg BID, 8 weeks with 2 week taper

Intervention Type DRUG

PD 0332334

Capsules, oral, 225 mg BID, 8 weeks with 2 week taper

Intervention Type DRUG

PD 0332334

Capsules, oral, 75 mg BID, 8 weeks with 2 week taper

Intervention Type DRUG

Paroxetine

Capsules, oral, Paroxetine 20 mg QD, 8 weeks with 2 week taper

Intervention Type DRUG

Placebo

Capsules, oral, placebo bid, 8 weeks with 2 week taper

Intervention Type DRUG

Other Intervention Names

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imagabalin

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Litchfield Park, Arizona, United States

Site Status

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Costa Mesa, California, United States

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Pasadena, California, United States

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Redlands, California, United States

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Denver, Colorado, United States

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Norwich, Connecticut, United States

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Altamonte Springs, Florida, United States

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Maitland, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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South Miami, Florida, United States

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Terre Haute, Indiana, United States

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Overland Park, Kansas, United States

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Topeka, Kansas, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Saint Charles, Missouri, United States

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Las Vegas, Nevada, United States

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Clementon, New Jersey, United States

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Willingboro, New Jersey, United States

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Albuquerque, New Mexico, United States

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Brooklyn, New York, United States

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New York, New York, United States

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The Bronx, New York, United States

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The Bronx, New York, United States

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Raleigh, North Carolina, United States

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Toledo, Ohio, United States

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Toledo, Ohio, United States

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Bethany, Oklahoma, United States

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Bala-Cynwyd, Pennsylvania, United States

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Media, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Columbia, South Carolina, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Lake Jackson, Texas, United States

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San Antonio, Texas, United States

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Burlington, Vermont, United States

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Charlottesville, Virginia, United States

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Charlottesville, Virginia, United States

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Waukesha, Wisconsin, United States

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Budapest, , Hungary

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Budapest, , Hungary

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Catania, , Italy

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Torino, , Italy

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Khotkovo, Moscow Region, , Russia

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Seoul, , South Korea

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Seoul, , South Korea

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Countries

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United States Hungary Italy Russia South Korea

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5361019&StudyName=A%2010-week%20study%20evaluating%20the%20efficacy%20and%20safety%20of%20PD%200332334%20in%20patients%20with%20generalized%20anxiety%20disorder%20%281%29%0A

To obtain contact information for a study center near you, click here.

Other Identifiers

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A5361019

Identifier Type: -

Identifier Source: org_study_id