A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (2)

NCT00658372

Last updated date
Study Location
Pfizer Investigational Site
Arcadia, California, 91007-3462, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Generalized Anxiety Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Generalized Anxiety DisorderAn Open-label Study to Investigate the Absorption, Metabolism and Excretion of Radiolabeled PD 0332334 in Six Healthy Male Volunteers
NCT00537615
  1. New Haven, Connecticut
Male
18 Years+
years
MULTIPLE SITES
Generalized Anxiety DisorderEvaluating The Effects Of Cimetidine On The Elimination Of PD 0332334 From The Body
NCT00800280
  1. New Haven, Connecticut
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Generalized Anxiety Disorder6-Month Open-Label Safety Study Of PD 0332334 In Elderly Patients With Generalized Anxiety Disorder (GAD)
NCT00738738
  1. Orlando, Florida
  2. Prairie Village, Kansas
ALL GENDERS
65 Years+
years
MULTIPLE SITES
Generalized Anxiety DisorderA 52-Week Open-Label Safety Study of PD 0332334 in Subjects With Generalized Anxiety Disorder (GAD)
NCT00735267
  1. Birmingham, Alabama
  2. Litchfield Park, Arizona
  3. Arcadia, California
  4. Beverly Hills, California
  5. Costa Mesa, California
  6. Costa Mesa, California
  7. Encino, California
  8. Escondido, California
  9. Murrieta, California
  10. National City, California
  11. Newport Beach, California
  12. Orange, California
  13. Pasadena, California
  14. Redlands, California
  15. San Diego, California
  16. San Diego, California
  17. Sherman Oaks, California
  18. Temecula, California
  19. Upland, California
  20. Wildomar, California
  21. Denver, Colorado
  22. Hamden, Connecticut
  23. Norwich, Connecticut
  24. Altamonte Springs, Florida
  25. Ft. Myers, Florida
  26. Jacksonville, Florida
  27. Maitland, Florida
  28. Miami, Florida
  29. Miami, Florida
  30. Orange City, Florida
  31. Orlando, Florida
  32. South Miami, Florida
  33. West Palm Beach, Florida
  34. Atlanta, Georgia
  35. Atlanta, Georgia
  36. Marietta, Georgia
  37. Libertyville, Illinois
  38. Naperville, Illinois
  39. Park Ridge, Illinois
  40. Greenwood, Indiana
  41. Terre Haute, Indiana
  42. Overland Park, Kansas
  43. Prairie Village, Kansas
  44. Wichita, Kansas
  45. Owensboro, Kentucky
  46. Lake Charles, Louisiana
  47. Baltimore, Maryland
  48. Belmont, Massachusetts
  49. Boston, Massachusetts
  50. Fall River, Massachusetts
  51. Haverhill, Massachusetts
  52. Pittsfield, Massachusetts
  53. Omaha, Nebraska
  54. Las Vegas, Nevada
  55. Nashua, New Hampshire
  56. Albuquerque, New Mexico
  57. Bronx, New York
  58. Brooklyn, New York
  59. New York, New York
  60. New York, New York
  61. New York, New York
  62. Rochester, New York
  63. Raleigh, North Carolina
  64. Columbus, Ohio
  65. Dayton, Ohio
  66. Toledo, Ohio
  67. Toledo, Ohio
  68. Bethany, Oklahoma
  69. Oklahoma City, Oklahoma
  70. Oklahoma City, Oklahoma
  71. Portland, Oregon
  72. Salem, Oregon
  73. Allentown, Pennsylvania
  74. Media, Pennsylvania
  75. Norristown, Pennsylvania
  76. Philadelphia, Pennsylvania
  77. Lincoln, Rhode Island
  78. Columbia, South Carolina
  79. Memphis, Tennessee
  80. Memphis, Tennessee
  81. Austin, Texas
  82. Dallas, Texas
  83. Dallas, Texas
  84. DeSoto, Texas
  85. Houston, Texas
  86. Houston, Texas
  87. Lake Jackson, Texas
  88. San Antonio, Texas
  89. Woodstock, Vermont
  90. Charlottesville, Virginia
  91. Seattle, Washington
  92. Middleton, Wisconsin
  93. Waukesha, Wisconsin
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (2)
Official Title  ICMJE 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
Brief Summary This is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects, ages 18 to 65, with generalized anxiety disorder.
Detailed Description 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Generalized Anxiety Disorder
Intervention  ICMJE
  • Drug: PD 0332334
    Capsules, oral, 225 mg BID, 8 weeks with 2 week taper
    Other Name: imagabalin
  • Drug: PD 0332334
    Capsules, oral, 300 mg BID, 8 weeks with 2 week taper
  • Drug: Paroxetine
    Capsules, oral, Paroxetine, 20 mg QD, 8 weeks with 2 week taper
  • Drug: Placebo
    Capsules, oral, placebo, BID, 8 weeks with 2 week taper
Study Arms  ICMJE
  • Experimental: PD 0332334 225 mg BID
    Intervention: Drug: PD 0332334
  • Experimental: PD 0332334 300 mg BID
    Intervention: Drug: PD 0332334
  • Active Comparator: Paroxetine 20 mg QD
    Intervention: Drug: Paroxetine
  • Placebo Comparator: Placebo BID
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 12, 2010)
360
Original Enrollment  ICMJE
 (submitted: April 9, 2008)
528
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary,   Russian Federation,   Taiwan,   United States
Removed Location Countries Italy
 
Administrative Information
NCT Number  ICMJE NCT00658372
Other Study ID Numbers  ICMJE A5361018
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP