Pregabalin in the Treatment of Patients With Generalized Anxiety Disorder (GAD).

Last updated: January 21, 2021
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Overall Status: Completed

Phase

3

Condition

Panic Disorders

Anxiety Disorders

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT00413010
A0081103
  • Ages > 18
  • All Genders

Study Summary

The primary objective of this study is to evaluate the efficacy of pregabalin as compared to placebo in the treatment of patients with general anxiety disorder (GAD). Efficacy will be measured by the improvement in the total Hamilton Anxiety Rating Scale (HAM-A) scores from baseline observed following 8 weeks of double-blind treatment or at earlier termination during the double-blind treatment phase and analyzed using a mixed linear model for repeated measures.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult male and female subjects with primary DSM-IV diagnosis of GAD, as confirmed bythe MINI structured interview.
  • Historical failure to respond optimally to a GAD treatment

Exclusion

Exclusion Criteria:

  • Current primary DSM-IV (Diagnostic and Statistical Manual of Mental Disorders 4thedition) diagnosis of major depressive disorder with or without seasonal pattern,dysthmic disorder, depressive disorder NOS (not otherwise specified), social phobia,panic disorder with or without agoraphobia, post traumatic stress disorder,dissociative disorder, borderline personality disorder, obsessive-compulsive disorder,antisocial personality disorder, as defined in the DSM-IV TR (Diagnostic andStatistical Manual of Mental Disorders 4th edition, Text Revision).
  • Past and/or current DSM-IV diagnosis of schizophrenia, schizoaffective disorder, otherpsychotic disorders, bipolar disorders (I or II), factitious disorder or cognitivedisorder (including delirium, dementia, and amnestic disorder).

Study Design

Total Participants: 356
Study Start date:
December 01, 2006
Estimated Completion Date:
March 31, 2008

Study Description

Further enrollment in this study was stopped on January 28, 2008 based on the recommendation of an independent data monitoring committee. The recommendation to stop the study was not based on any safety findings.

Connect with a study center

  • Pfizer Investigational Site

    Brno, 602 00
    Czechia

    Site Not Available

  • Pfizer Investigational Site

    Litomerice, 412 01
    Czechia

    Site Not Available

  • Pfizer Investigational Site

    Praha 2, 120 00
    Czechia

    Site Not Available

  • Pfizer Investigational Site

    Praha 5, 158 00
    Czechia

    Site Not Available

  • Pfizer Investigational Site

    Praha 6, 163 00
    Czechia

    Site Not Available

  • Pfizer Investigational Site

    Praha 8 - Bohnice, 181 03
    Czechia

    Site Not Available

  • Pfizer Investigational Site

    Viljandi, Viljandi Mk. 71024
    Estonia

    Site Not Available

  • Pfizer Investigational Site

    Tallinn, 10614
    Estonia

    Site Not Available

  • Pfizer Investigational Site

    Tartu, 50417
    Estonia

    Site Not Available

  • Pfizer Investigational Site

    Helsinki, 00029 HUS
    Finland

    Site Not Available

  • Pfizer Investigational Site

    Joensuu, 80100
    Finland

    Site Not Available

  • Pfizer Investigational Site

    Kuopio, 70110
    Finland

    Site Not Available

  • Pfizer Investigational Site

    Budapest, 1083
    Hungary

    Site Not Available

  • Pfizer Investigational Site

    Pecs, 7623
    Hungary

    Site Not Available

  • Pfizer Investigational Site

    Moscow, 115522
    Russian Federation

    Site Not Available

  • Pfizer Investigational Site

    Smolensk, 214018
    Russian Federation

    Site Not Available

  • Pfizer Investigational Site

    St Petersburg, 190121
    Russian Federation

    Site Not Available

  • Pfizer Investigational Site

    St. Petersburg, 191180
    Russian Federation

    Site Not Available

  • Pfizer Investigational Site

    Belgrade, 11000
    Serbia

    Site Not Available

  • Pfizer Investigational Site

    Kragujevac, 34000
    Serbia

    Site Not Available

  • Pfizer Investigational Site

    Dnipropetrovsk, 49005
    Ukraine

    Site Not Available

  • Pfizer Investigational Site

    Donetsk, 83037
    Ukraine

    Site Not Available

  • Pfizer Investigational Site

    Kyiv, 01030
    Ukraine

    Site Not Available

  • Pfizer Investigational Site

    Lugansk, 91045
    Ukraine

    Site Not Available

  • Pfizer Investigational Site

    Lviv, 79021
    Ukraine

    Site Not Available

  • Pfizer Investigational Site

    Arcadia, California 91007-3462
    United States

    Site Not Available

  • Pfizer Investigational Site

    Burbank, California 91506
    United States

    Site Not Available

  • Pfizer Investigational Site

    Redlands, California 92374
    United States

    Site Not Available

  • Pfizer Investigational Site

    Sherman Oaks, California 91403
    United States

    Site Not Available

  • Pfizer Investigational Site

    Norwich, Connecticut 06360
    United States

    Site Not Available

  • Pfizer Investigational Site

    Destin, Florida 32541
    United States

    Site Not Available

  • Pfizer Investigational Site

    Fort Walton Beach, Florida 32547
    United States

    Site Not Available

  • Pfizer Investigational Site

    Miami, Florida 33143
    United States

    Site Not Available

  • Pfizer Investigational Site

    South Miami, Florida 33143
    United States

    Site Not Available

  • Pfizer Investigational Site

    Overland Park, Kansas 66212
    United States

    Site Not Available

  • Pfizer Investigational Site

    Wichita, Kansas 67207
    United States

    Site Not Available

  • Pfizer Investigational Site

    Shreveport, Louisiana 71104
    United States

    Site Not Available

  • Pfizer Investigational Site

    Baltimore, Maryland 21208
    United States

    Site Not Available

  • Pfizer Investigational Site

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Pfizer Investigational Site

    Olive Branch, Mississippi 38654
    United States

    Site Not Available

  • Pfizer Investigational Site

    Saint Charles, Missouri 63301
    United States

    Site Not Available

  • Pfizer Investigational Site

    St. Charles, Missouri 63301
    United States

    Site Not Available

  • Pfizer Investigational Site

    Omaha, Nebraska 68131
    United States

    Site Not Available

  • Pfizer Investigational Site

    Clementon, New Jersey 08021
    United States

    Site Not Available

  • Pfizer Investigational Site

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Pfizer Investigational Site

    New York, New York 10128-1708
    United States

    Site Not Available

  • Pfizer Investigational Site

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • Pfizer Investigational Site

    Cincinnati, Ohio 45227
    United States

    Site Not Available

  • Pfizer Investigational Site

    Cleveland, Ohio 44109-1998
    United States

    Site Not Available

  • Pfizer Investigational Site

    Bala Cynwyd, Pennsylvania 19004
    United States

    Site Not Available

  • Pfizer Investigational Site

    Bala-Cynwyd, Pennsylvania 19004
    United States

    Site Not Available

  • Pfizer Investigational Site

    Media, Pennsylvania 19063
    United States

    Site Not Available

  • Pfizer Investigational Site

    Philadelphia, Pennsylvania 19136
    United States

    Site Not Available

  • Pfizer Investigational Site

    Columbia, South Carolina 29201
    United States

    Site Not Available

  • Pfizer Investigational Site

    Memphis, Tennessee 38133
    United States

    Site Not Available

  • Pfizer Investigational Site

    Houston, Texas 77008
    United States

    Site Not Available

  • Pfizer Investigational Site

    Lake Jackson, Texas 77566
    United States

    Site Not Available

  • Pfizer Investigational Site

    Waukesha, Wisconsin 53188-1660
    United States

    Site Not Available

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