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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00413010
First received: December 15, 2006
Last updated: December 3, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Generalized Anxiety Disorder
Drug: pregabalin
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: An 8-Week, Double-Blind, Placebo-Controlled, Phase 3 Trial of Pregabalin (150-600 mg/Day) in the Adjunctive Treatment of Patients With Generalized Anxiety Disorder (GAD) Who Have Not Optimally Responded to Existing Therapies(GAD)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in HAM-A Total Score at Weekly Visits [ Time Frame: Baseline, Weeks 1 through Week 8 ] [ Designated as safety issue: No ]
  • Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: Weeks 1 through Week 8 ] [ Designated as safety issue: No ]
  • Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score [ Time Frame: Week 1 through Week 8 ] [ Designated as safety issue: No ]
  • Time to Onset of Sustained Hamilton Anxiety Rating Scale (HAM-A) Improvement [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score [ Time Frame: Week 1 through Week 8 ] [ Designated as safety issue: No ]
  • Clinical Global Impression of Severity (CGI-S) Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Change in Hamilton Depression Rating Scale (HAM-D) Total Score [ Time Frame: Weeks 1 through Week 8 ] [ Designated as safety issue: No ]

Enrollment: 356
Study Start Date: December 2006
Study Completion Date: March 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm 2 Drug: placebo
placebo + concurrent GAD treatment from the open-label study period
Experimental: Arm 1 Drug: pregabalin
pregabalin 150-600 mg/day flexibly dosed for the first 6 weeks and fixed dosed for the last 2 weeks of total 8 weeks of double blind study period, + concurrent GAD treatment from the open-label study period
Other Name: Lyrica

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Current primary DSM-IV (Diagnostic and Statistical Manual of Mental Disorders 4th edition) 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 and Statistical Manual of Mental Disorders 4th edition, Text Revision).
  • Past and/or current DSM-IV diagnosis of schizophrenia, schizoaffective disorder, other psychotic disorders, bipolar disorders (I or II), factitious disorder or cognitive disorder (including delirium, dementia, and amnestic disorder).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413010

  Hide Study Locations
Locations
United States, California
Pfizer Investigational Site
Arcadia, California, United States, 91007-3462
Pfizer Investigational Site
Burbank, California, United States, 91506
Pfizer Investigational Site
Redlands, California, United States, 92374
Pfizer Investigational Site
Sherman Oaks, California, United States, 91403
United States, Connecticut
Pfizer Investigational Site
Norwich, Connecticut, United States, 06360
United States, Florida
Pfizer Investigational Site
Destin, Florida, United States, 32541
Pfizer Investigational Site
Fort Walton Beach, Florida, United States, 32547
Pfizer Investigational Site
Miami, Florida, United States, 33143
Pfizer Investigational Site
South Miami, Florida, United States, 33143
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
Pfizer Investigational Site
Wichita, Kansas, United States, 67207
United States, Louisiana
Pfizer Investigational Site
Shreveport, Louisiana, United States, 71101
Pfizer Investigational Site
Shreveport, Louisiana, United States, 71104
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21208
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
United States, Mississippi
Pfizer Investigational Site
Olive Branch, Mississippi, United States, 38654
United States, Missouri
Pfizer Investigational Site
St. Charles, Missouri, United States, 63301
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68131
United States, New Jersey
Pfizer Investigational Site
Clementon, New Jersey, United States, 08021
United States, New Mexico
Pfizer Investigational Site
Albuquerque, New Mexico, United States, 87102
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10128-1708
United States, Ohio
Pfizer Investigational Site
Beachwood, Ohio, United States, 44122
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45227
Pfizer Investigational Site
Cleveland, Ohio, United States, 44109-1998
United States, Pennsylvania
Pfizer Investigational Site
Bala Cynwyd, Pennsylvania, United States, 19004
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Media, Pennsylvania, United States, 19063
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19104-3309
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Philadelphia, Pennsylvania, United States, 19136
United States, South Carolina
Pfizer Investigational Site
Columbia, South Carolina, United States, 29201
United States, Tennessee
Pfizer Investigational Site
Memphis, Tennessee, United States, 38117
Pfizer Investigational Site
Memphis, Tennessee, United States, 38133
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77008
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Houston, Texas, United States, 77074
Pfizer Investigational Site
Lake Jackson, Texas, United States, 77566
United States, Wisconsin
Pfizer Investigational Site
Waukesha, Wisconsin, United States, 53188-1660
Czech Republic
Pfizer Investigational Site
Brno, Czech Republic, 602 00
Pfizer Investigational Site
Litomerice, Czech Republic, 412 01
Pfizer Investigational Site
Praha 2, Czech Republic, 120 00
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Praha 5, Czech Republic, 158 00
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Praha 6, Czech Republic, 163 00
Pfizer Investigational Site
Praha 8 - Bohnice, Czech Republic, 181 03
Estonia
Pfizer Investigational Site
Viljandi, Viljandi mk., Estonia, 71024
Pfizer Investigational Site
Tallinn, Estonia, 10614
Pfizer Investigational Site
Tartu, Estonia, 50417
Finland
Pfizer Investigational Site
Helsinki, Finland, 00029 HUS
Pfizer Investigational Site
Joensuu, Finland, 80100
Pfizer Investigational Site
Kuopio, Finland, 70110
Hungary
Pfizer Investigational Site
Budapest, Hungary, 1137
Pfizer Investigational Site
Budapest, Hungary, 1083
Pfizer Investigational Site
Pecs, Hungary, 7623
Russian Federation
Pfizer Investigational Site
Moscow, Russian Federation, 119034
Pfizer Investigational Site
Moscow, Russian Federation, 123367
Pfizer Investigational Site
Moscow, Russian Federation, 115522
Pfizer Investigational Site
Smolensk, Russian Federation, 214019
Pfizer Investigational Site
Smolensk, Russian Federation, 214018
Pfizer Investigational Site
St Petersburg, Russian Federation, 190121
Pfizer Investigational Site
St. Petersburg, Russian Federation, 192019
Pfizer Investigational Site
St. Petersburg, Russian Federation, 191180
Serbia
Pfizer Investigational Site
Belgrade, Serbia, 11 000
Pfizer Investigational Site
Belgrade, Serbia
Pfizer Investigational Site
Belgrade, Serbia, 11000
Pfizer Investigational Site
Kragujevac, Serbia, 34000
Ukraine
Pfizer Investigational Site
Dnipropetrovsk, Ukraine, 49005
Pfizer Investigational Site
Dnipropetrovsk, Ukraine, 49115
Pfizer Investigational Site
Donetsk, Ukraine, 83037
Pfizer Investigational Site
Kyiv, Ukraine, 01030
Pfizer Investigational Site
Lugansk, Ukraine, 91045
Pfizer Investigational Site
Lviv, Ukraine, 79021
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00413010     History of Changes
Other Study ID Numbers: A0081103
Study First Received: December 15, 2006
Results First Received: February 27, 2009
Last Updated: December 3, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 28, 2014