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

November 9, 2012 updated by: Pfizer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

551

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90210
        • Pfizer Investigational Site
      • Encino, California, United States, 91316
        • Pfizer Investigational Site
      • National City, California, United States, 91950
        • Pfizer Investigational Site
      • Newport Beach, California, United States, 92660-2452
        • Pfizer Investigational Site
      • San Diego, California, United States, 92103
        • Pfizer Investigational Site
      • Sherman Oaks, California, United States, 91403
        • Pfizer Investigational Site
    • Connecticut
      • Farmington, Connecticut, United States, 06030-6415
        • Pfizer Investigational Site
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States, 32256-2006
        • Pfizer Investigational Site
      • Orlando, Florida, United States, 32806
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33613
        • Pfizer Investigational Site
      • West Palm Beach, Florida, United States, 33407
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Pfizer Investigational Site
      • Atlanta, Georgia, United States, 30328
        • Pfizer Investigational Site
      • Marietta, Georgia, United States, 30060
        • Pfizer Investigational Site
    • Illinois
      • Libertyville, Illinois, United States, 60048
        • Pfizer Investigational Site
      • Schaumburg, Illinois, United States, 60194
        • Pfizer Investigational Site
    • Indiana
      • Lafayette, Indiana, United States, 47905
        • Pfizer Investigational Site
    • Kentucky
      • Owensboro, Kentucky, United States, 42301
        • Pfizer Investigational Site
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Pfizer Investigational Site
    • Maryland
      • Glen Burnie, Maryland, United States, 21061
        • Pfizer Investigational Site
      • Rockville, Maryland, United States, 20852
        • Pfizer Investigational Site
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • Pfizer Investigational Site
      • Fall River, Massachusetts, United States, 02721
        • Pfizer Investigational Site
    • Michigan
      • Farmington Hills, Michigan, United States, 48336
        • Pfizer Investigational Site
    • New Hampshire
      • Nashua, New Hampshire, United States, 03060
        • Pfizer Investigational Site
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08002
        • Pfizer Investigational Site
      • Piscataway, New Jersey, United States, 08854-5635
        • Pfizer Investigational Site
    • New York
      • Brooklyn, New York, United States, 11201
        • Pfizer Investigational Site
      • New York, New York, United States, 10024
        • Pfizer Investigational Site
      • Staten Island, New York, United States, 10312
        • Pfizer Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Pfizer Investigational Site
      • Durham, North Carolina, United States, 27710
        • Pfizer Investigational Site
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19149
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19139
        • Pfizer Investigational Site
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02865
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, United States, 77057
        • Pfizer Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23230
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, United States, 98104
        • Pfizer Investigational Site
    • Wisconsin
      • Middleton, Wisconsin, United States, 53562
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PD 0332334 175 mg BID
Drug: PD 0332334
Capsules, oral, 300 mg BID, 8 weeks with 2 week taper.
Other Names:
  • imagabalin
Drug: PD 0332334
Capsules, oral, 225 mg BID, 8 weeks with 2 week taper.
Drug: PD 0332334
Capsules, oral, 175 mg BID, 8 weeks with 2 week taper.
Experimental: PD 0332334 225 mg BID
Drug: PD 0332334
Capsules, oral, 300 mg BID, 8 weeks with 2 week taper.
Other Names:
  • imagabalin
Drug: PD 0332334
Capsules, oral, 225 mg BID, 8 weeks with 2 week taper.
Drug: PD 0332334
Capsules, oral, 175 mg BID, 8 weeks with 2 week taper.
Placebo Comparator: Placebo BID
Drug: Placebo
Capsules, oral, placebo BID, 8 weeks with 2 week taper.
Experimental: PD 0332334 300 mg BID
Drug: PD 0332334
Capsules, oral, 300 mg BID, 8 weeks with 2 week taper.
Other Names:
  • imagabalin
Drug: PD 0332334
Capsules, oral, 225 mg BID, 8 weeks with 2 week taper.
Drug: PD 0332334
Capsules, oral, 175 mg BID, 8 weeks with 2 week taper.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
8 weeks
The safety and tolerability of PD 0332334 in subjects with GAD will be monitored in this study.
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in the psychic subscale score of the HAM-A (Items 1-6 and 14) at Week 8.
Time Frame: 8 weeks
8 weeks
Response rate on the clinician-rated CGI-I at Week 1 and Week 8.
Time Frame: 8 weeks
8 weeks
Change from Baseline to Week 8 on the Medical Outcomes Study-Sleep Scale (MOSS-SS) subscales.
Time Frame: 8 weeks
8 weeks
Change from Baseline to Week 8 on the Sheehan Disability Scale (SDS) total score.
Time Frame: 8 weeks
8 weeks
Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the DAS-A (total score).
Time Frame: 8 weeks
8 weeks
Response rate on the HAM-A at Week 1 and Week 8.
Time Frame: 8 weeks
8 weeks
Change from Baseline in the somatic subscale score of the HAM-A (Items 7-13) at Week 8.
Time Frame: 8 weeks
8 weeks
Remission rate based on the HAM-A at Week 1 and Week 8.
Time Frame: 8 weeks
8 weeks
Response rate on the patient-rated PGI-C at Week 8.
Time Frame: 8 weeks
8 weeks
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
1 week
Change from Baseline in HAM-A total score at Weeks 1, 2, 4, and 6.
Time Frame: 6 weeks
6 weeks
Change from Baseline in the 17-item HAM-D total score at Weeks 1, 2, 4, and 8.
Time Frame: 8 weeks
8 weeks
Change from Baseline to Week 8 on the Sheehan Disability Scale subscales.
Time Frame: 8 weeks
8 weeks
Change from Baseline in CGI-S at Week 8.
Time Frame: 8 weeks
8 weeks
Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS-SS) total score.
Time Frame: 8 weeks
8 weeks
Change from Baseline to Week 8 in the Q-Les-Q General Activities Score.
Time Frame: 8 weeks
8 weeks
Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS-SS) total score.
Time Frame: 1 week
1 week
Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the GA-VAS (diary).
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

October 10, 2007

First Submitted That Met QC Criteria

October 10, 2007

First Posted (Estimate)

October 11, 2007

Study Record Updates

Last Update Posted (Estimate)

November 16, 2012

Last Update Submitted That Met QC Criteria

November 9, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5361017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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