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

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
pregabalin
placebo
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm 2

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores
Change from baseline: average across visit weeks using mixed model. HAM-A=clinician-rated interview measuring presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, & restlessness. Total score ranges from 0 to 56; higher score indicates greater anxiety.

Secondary Outcome Measures

Change in HAM-A Total Score at Weekly Visits
Change: score at each study week minus score at baseline. HAM-A, a clinician-rated interview, measures presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, & restlessness. Total score ranges from 0 to 56; higher score indicates greater anxiety.
Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A)
Responders = YES if subjects achieved a >= 50% decrease in HAM-A total score from Baseline to respective study week. HAM-A is a clinician-rated interview measuring the presence of anxiety-related symptoms in 14 areas. Total score ranges from 0 to 56; higher score indicates greater anxiety.
Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score
Participant in remission defined as HAM-A total score of <= 7. HAM-A=clinician-rated interview measuring presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, & restlessness. Total score ranges 0 - 56; higher score indicates greater anxiety.
Time to Onset of Sustained Hamilton Anxiety Rating Scale (HAM-A) Improvement
Time to sustained improvement was defined as time to 50% or greater reduction in HAM-A total score from Baseline, which was sustained for the remainder of the study. HAM-A is a clinician-rated interview measuring the presence of anxiety-related symptoms in 14 areas. Total score ranges from 0 to 56; a higher score indicates greater anxiety.
Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score
Responders = YES using CGI-I if score indicated much improved or very much improved at the last study week. CGI-I is a clinician-rated instrument that measures change in subject's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Clinical Global Impression of Severity (CGI-S) Score
CGI-S is a clinician-rated instrument measuring the severity of a subject's symptoms on a 7-point categorical scale. Scores range from 1 (not at all ill) to 7 (among the most extremely ill patients). Higher score indicates that the subject is more ill.
Change in Hamilton Depression Rating Scale (HAM-D) Total Score
Change: score at each study week minus score at baseline. HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, & weight loss). Total score ranges from 0 to 52; higher scores indicate more depression.

Full Information

First Posted
December 15, 2006
Last Updated
January 21, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00413010
Brief Title
Pregabalin in the Treatment of Patients With Generalized Anxiety Disorder (GAD).
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
356 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 2
Arm Type
Placebo Comparator
Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
pregabalin
Other Intervention Name(s)
Lyrica
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo + concurrent GAD treatment from the open-label study period
Primary Outcome Measure Information:
Title
Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores
Description
Change from baseline: average across visit weeks using mixed model. HAM-A=clinician-rated interview measuring presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, & restlessness. Total score ranges from 0 to 56; higher score indicates greater anxiety.
Time Frame
Baseline, 8 weeks
Secondary Outcome Measure Information:
Title
Change in HAM-A Total Score at Weekly Visits
Description
Change: score at each study week minus score at baseline. HAM-A, a clinician-rated interview, measures presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, & restlessness. Total score ranges from 0 to 56; higher score indicates greater anxiety.
Time Frame
Baseline, Weeks 1 through Week 8
Title
Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A)
Description
Responders = YES if subjects achieved a >= 50% decrease in HAM-A total score from Baseline to respective study week. HAM-A is a clinician-rated interview measuring the presence of anxiety-related symptoms in 14 areas. Total score ranges from 0 to 56; higher score indicates greater anxiety.
Time Frame
Weeks 1 through Week 8
Title
Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score
Description
Participant in remission defined as HAM-A total score of <= 7. HAM-A=clinician-rated interview measuring presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, & restlessness. Total score ranges 0 - 56; higher score indicates greater anxiety.
Time Frame
Week 1 through Week 8
Title
Time to Onset of Sustained Hamilton Anxiety Rating Scale (HAM-A) Improvement
Description
Time to sustained improvement was defined as time to 50% or greater reduction in HAM-A total score from Baseline, which was sustained for the remainder of the study. HAM-A is a clinician-rated interview measuring the presence of anxiety-related symptoms in 14 areas. Total score ranges from 0 to 56; a higher score indicates greater anxiety.
Time Frame
Week 8
Title
Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score
Description
Responders = YES using CGI-I if score indicated much improved or very much improved at the last study week. CGI-I is a clinician-rated instrument that measures change in subject's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Time Frame
Week 1 through Week 8
Title
Clinical Global Impression of Severity (CGI-S) Score
Description
CGI-S is a clinician-rated instrument measuring the severity of a subject's symptoms on a 7-point categorical scale. Scores range from 1 (not at all ill) to 7 (among the most extremely ill patients). Higher score indicates that the subject is more ill.
Time Frame
Week 8
Title
Change in Hamilton Depression Rating Scale (HAM-D) Total Score
Description
Change: score at each study week minus score at baseline. HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, & weight loss). Total score ranges from 0 to 52; higher scores indicate more depression.
Time Frame
Weeks 1 through Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Arcadia
State/Province
California
ZIP/Postal Code
91007-3462
Country
United States
Facility Name
Pfizer Investigational Site
City
Burbank
State/Province
California
ZIP/Postal Code
91506
Country
United States
Facility Name
Pfizer Investigational Site
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Pfizer Investigational Site
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Pfizer Investigational Site
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Pfizer Investigational Site
City
Destin
State/Province
Florida
ZIP/Postal Code
32541
Country
United States
Facility Name
Pfizer Investigational Site
City
Fort Walton Beach
State/Province
Florida
ZIP/Postal Code
32547
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Pfizer Investigational Site
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Pfizer Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Pfizer Investigational Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Pfizer Investigational Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Pfizer Investigational Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71104
Country
United States
Facility Name
Pfizer Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
Pfizer Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Pfizer Investigational Site
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Facility Name
Pfizer Investigational Site
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
Pfizer Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Pfizer Investigational Site
City
Clementon
State/Province
New Jersey
ZIP/Postal Code
08021
Country
United States
Facility Name
Pfizer Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10128-1708
Country
United States
Facility Name
Pfizer Investigational Site
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Pfizer Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109-1998
Country
United States
Facility Name
Pfizer Investigational Site
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Pfizer Investigational Site
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Pfizer Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-3309
Country
United States
Facility Name
Pfizer Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19136
Country
United States
Facility Name
Pfizer Investigational Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Pfizer Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38117
Country
United States
Facility Name
Pfizer Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38133
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Pfizer Investigational Site
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
Pfizer Investigational Site
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188-1660
Country
United States
Facility Name
Pfizer Investigational Site
City
Brno
ZIP/Postal Code
602 00
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Litomerice
ZIP/Postal Code
412 01
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Praha 2
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Praha 5
ZIP/Postal Code
158 00
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Praha 6
ZIP/Postal Code
163 00
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Praha 8 - Bohnice
ZIP/Postal Code
181 03
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Viljandi
State/Province
Viljandi Mk.
ZIP/Postal Code
71024
Country
Estonia
Facility Name
Pfizer Investigational Site
City
Tallinn
ZIP/Postal Code
10614
Country
Estonia
Facility Name
Pfizer Investigational Site
City
Tartu
ZIP/Postal Code
50417
Country
Estonia
Facility Name
Pfizer Investigational Site
City
Helsinki
ZIP/Postal Code
00029 HUS
Country
Finland
Facility Name
Pfizer Investigational Site
City
Joensuu
ZIP/Postal Code
80100
Country
Finland
Facility Name
Pfizer Investigational Site
City
Kuopio
ZIP/Postal Code
70110
Country
Finland
Facility Name
Pfizer Investigational Site
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Budapest
ZIP/Postal Code
1137
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Pecs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
119034
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
123367
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St. Petersburg
ZIP/Postal Code
191180
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St. Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Belgrade
ZIP/Postal Code
11 000
Country
Serbia
Facility Name
Pfizer Investigational Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Pfizer Investigational Site
City
Belgrade
Country
Serbia
Facility Name
Pfizer Investigational Site
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Pfizer Investigational Site
City
Dnipropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Dnipropetrovsk
ZIP/Postal Code
49115
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Donetsk
ZIP/Postal Code
83037
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kyiv
ZIP/Postal Code
01030
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Lugansk
ZIP/Postal Code
91045
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
22302014
Citation
Rickels K, Shiovitz TM, Ramey TS, Weaver JJ, Knapp LE, Miceli JJ. Adjunctive therapy with pregabalin in generalized anxiety disorder patients with partial response to SSRI or SNRI treatment. Int Clin Psychopharmacol. 2012 May;27(3):142-50. doi: 10.1097/YIC.0b013e328350b133.
Results Reference
derived

Learn more about this trial

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

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