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

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

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.

Study Overview

• Status: Terminated
• Conditions: Generalized Anxiety Disorder
• Intervention / Treatment: Drug: PD 0332334; Drug: PD 0332334; Drug: PD 0332334; Drug: Paroxetine; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 501
• Phase: Phase 3

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1095
    • Pfizer Investigational Site
  • Budapest, Hungary, 1137
    • Pfizer Investigational Site
• Italy
  • Catania, Italy, 95123
    • Pfizer Investigational Site
  • Torino, Italy, 10126
    • Pfizer Investigational Site
• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 135-710
    • Pfizer Investigational Site
• Russian Federation
  • Khotkovo, Moscow region, Russian Federation, 142601
    • Pfizer Investigational Site
• United States
  • Arizona
    • Litchfield Park, Arizona, United States, 85340
      • Pfizer Investigational Site
  • California
    • Costa Mesa, California, United States, 92626
      • Pfizer Investigational Site
    • Pasadena, California, United States, 91106
      • Pfizer Investigational Site
    • Redlands, California, United States, 92374
      • Pfizer Investigational Site
  • Colorado
    • Denver, Colorado, United States, 80239
      • Pfizer Investigational Site
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Pfizer Investigational Site
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • Pfizer Investigational Site
    • Maitland, Florida, United States, 32751
      • Pfizer Investigational Site
    • Miami, Florida, United States, 33126
      • Pfizer Investigational Site
    • Miami, Florida, United States, 33143
      • Pfizer Investigational Site
    • South Miami, Florida, United States, 33143
      • Pfizer Investigational Site
  • Indiana
    • Terre Haute, Indiana, United States, 47802
      • Pfizer Investigational Site
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Pfizer Investigational Site
    • Topeka, Kansas, United States, 66606
      • Pfizer Investigational Site
  • Louisiana
    • Shreveport, Louisiana, United States, 71104
      • Pfizer Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21208
      • Pfizer Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02135
      • Pfizer Investigational Site
  • Missouri
    • St. Charles, Missouri, United States, 63301
      • Pfizer Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89146
      • Pfizer Investigational Site
  • New Jersey
    • Clementon, New Jersey, United States, 08021
      • Pfizer Investigational Site
    • Willingboro, New Jersey, United States, 08046
      • Pfizer Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Pfizer Investigational Site
  • New York
    • Bronx, New York, United States, 10454
      • Pfizer Investigational Site
    • Bronx, New York, United States, 10467
      • Pfizer Investigational Site
    • Brooklyn, New York, United States, 11235
      • Pfizer Investigational Site
    • New York, New York, United States, 10023
      • Pfizer Investigational Site
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • Pfizer Investigational Site
  • Ohio
    • Toledo, Ohio, United States, 43623
      • Pfizer Investigational Site
    • Toledo, Ohio, United States, 43609
      • Pfizer Investigational Site
  • Oklahoma
    • Bethany, Oklahoma, United States, 73008
      • Pfizer Investigational Site
  • Pennsylvania
    • Bala Cynwyd, Pennsylvania, United States, 19004
      • Pfizer Investigational Site
    • Media, Pennsylvania, United States, 19063
      • Pfizer Investigational Site
    • Norristown, Pennsylvania, United States, 19401
      • Pfizer Investigational Site
    • Philadelphia, Pennsylvania, United States, 19104
      • Pfizer Investigational Site
    • Philadelphia, Pennsylvania, United States, 19136
      • Pfizer Investigational Site
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Pfizer Investigational Site
  • Tennessee
    • Memphis, Tennessee, United States, 38117
      • Pfizer Investigational Site
  • Texas
    • Austin, Texas, United States, 78756
      • Pfizer Investigational Site
    • Dallas, Texas, United States, 75231
      • Pfizer Investigational Site
    • Lake Jackson, Texas, United States, 77566
      • Pfizer Investigational Site
    • San Antonio, Texas, United States, 78229
      • Pfizer Investigational Site
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Pfizer Investigational Site
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Pfizer Investigational Site
    • Charlottesville, Virginia, United States, 22911
      • Pfizer Investigational Site
  • Wisconsin
    • Waukesha, Wisconsin, United States, 53188-1660
      • Pfizer Investigational Site

Participation Criteria

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 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PD 0332334 175 mg BID	Drug: PD 0332334; Capsules, oral, 175 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, 75 mg BID, 8 weeks with 2 week taper
Experimental: PD 0332334 225 mg BID	Drug: PD 0332334; Capsules, oral, 175 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, 75 mg BID, 8 weeks with 2 week taper
Experimental: PD 0332334 75 mg BID	Drug: PD 0332334; Capsules, oral, 175 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, 75 mg BID, 8 weeks with 2 week taper
Active Comparator: Paroxetine 20 mg QD	Drug: Paroxetine; Capsules, oral, Paroxetine 20 mg QD, 8 weeks with 2 week taper
Placebo Comparator: Placebo BID	Drug: Placebo; Capsules, oral, placebo 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.	8 weeks
The safety and tolerability of PD 0332334 in subjects with GAD will be monitored in this study	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Worsening and improvement from baseline to week 8 on the changes in the Sexual Functioning Questionnaire (CSFQ)	8 weeks
Response rate on the patient-rated PGI-C at week 8	8 weeks
Change from baseline to week 8 on the Sheehan Disability Scale subscales	8 weeks
Change from baseline in the somatic subscale score of the HAM-A (items 7 - 13)	8 weeks
Response rate on the HAM-A at week 1 and week 8	8 weeks
Response rate on the clinician-rated CGI-I ate week 1 and week 8	8 weeks
Change from Baseline in the psychic subscale score of the HAM A (Items 1- 6 and 14) at Week 8	8 weeks
Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Problems Index II	1 week
Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Problems Index II	8 weeks
Change from baseline in the HAM-A total score at weeks 1, 2, 4, and 6	6 weeks
Change from baseline in the 17-item HAM-D total score at weeks 1, 2, 4, and 8	8 weeks
Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale subscales	8 weeks
Remission rate based on the HAM A at Week 8	8 weeks
Change from baseline in CGI-S at week 8	8 weeks
Change from baseline to week 8 in the QLesQ General Activity Score	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)	1 week
Change from Baseline to Days 2 8 and Weeks 2, 4, 6, 8 on the DAS A (total score)	8 weeks
Change from baseline to week 8 on the Sheehan Disability Scale (SDS) total score	8 weeks
Change from baseline to Days 2-8 and weeks 2, 4, 6 and 8 on the GA-VAS (diary)	8 weeks
Average (across the week 1, 2, 4, 6 and 8 visits) HAM-A change from baseline score	8 weeks

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: April 8, 2008
• First Submitted That Met QC Criteria: April 8, 2008
• First Posted (Estimate): April 14, 2008

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

• Keywords: PD 0332334 phase 3 pivotal trial
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Paroxetine
• Other Study ID Numbers: A5361019