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

January 21, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
356

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brno, Czechia, 602 00
        • Pfizer Investigational Site
      • Litomerice, Czechia, 412 01
        • Pfizer Investigational Site
      • Praha 2, Czechia, 120 00
        • Pfizer Investigational Site
      • Praha 5, Czechia, 158 00
        • Pfizer Investigational Site
      • Praha 6, Czechia, 163 00
        • Pfizer Investigational Site
      • Praha 8 - Bohnice, Czechia, 181 03
        • Pfizer Investigational Site
  • Estonia
      • Tallinn, Estonia, 10614
        • Pfizer Investigational Site
      • Tartu, Estonia, 50417
        • Pfizer Investigational Site
    • Viljandi Mk.
      • Viljandi, Viljandi Mk., Estonia, 71024
        • Pfizer Investigational Site
  • Finland
      • Helsinki, Finland, 00029 HUS
        • Pfizer Investigational Site
      • Joensuu, Finland, 80100
        • Pfizer Investigational Site
      • Kuopio, Finland, 70110
        • Pfizer Investigational Site
  • Hungary
      • Budapest, Hungary, 1137
        • Pfizer Investigational Site
      • Budapest, Hungary, 1083
        • Pfizer Investigational Site
      • Pecs, Hungary, 7623
        • Pfizer Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 115522
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 119034
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 123367
        • 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
        • Pfizer Investigational Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Pfizer Investigational Site
      • Belgrade, Serbia, 11 000
        • Pfizer Investigational Site
      • Belgrade, Serbia
        • Pfizer Investigational Site
      • Kragujevac, Serbia, 34000
        • Pfizer Investigational Site
  • Ukraine
      • 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
        • Pfizer Investigational Site
  • United States
    • California
      • 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
        • Pfizer Investigational Site
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Pfizer Investigational Site
    • Florida
      • 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
        • Pfizer Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Pfizer Investigational Site
      • Wichita, Kansas, United States, 67207
        • Pfizer Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Pfizer Investigational Site
      • Shreveport, Louisiana, United States, 71104
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21208
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Pfizer Investigational Site
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
        • Pfizer Investigational Site
    • Missouri
      • Saint Charles, Missouri, United States, 63301
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Pfizer Investigational Site
    • New Jersey
      • Clementon, New Jersey, United States, 08021
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States, 10128-1708
        • Pfizer Investigational Site
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45227
        • Pfizer Investigational Site
      • Cleveland, Ohio, United States, 44109-1998
        • Pfizer Investigational Site
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Pfizer Investigational Site
      • Media, Pennsylvania, United States, 19063
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19136
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19104-3309
        • Pfizer Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Pfizer Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38133
        • Pfizer Investigational Site
      • Memphis, Tennessee, United States, 38117
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, United States, 77008
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77074
        • Pfizer Investigational Site
      • Lake Jackson, Texas, United States, 77566
        • Pfizer Investigational Site
    • Wisconsin
      • Waukesha, Wisconsin, United States, 53188-1660
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Lyrica
Placebo Comparator: Arm 2
Drug: placebo
placebo + concurrent GAD treatment from the open-label study period

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores
Time Frame: Baseline, 8 weeks
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.
Baseline, 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in HAM-A Total Score at Weekly Visits
Time Frame: Baseline, Weeks 1 through Week 8
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.
Baseline, Weeks 1 through Week 8
Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A)
Time Frame: Weeks 1 through Week 8
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.
Weeks 1 through Week 8
Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score
Time Frame: Week 1 through Week 8
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.
Week 1 through Week 8
Time to Onset of Sustained Hamilton Anxiety Rating Scale (HAM-A) Improvement
Time Frame: Week 8
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.
Week 8
Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score
Time Frame: Week 1 through Week 8
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).
Week 1 through Week 8
Clinical Global Impression of Severity (CGI-S) Score
Time Frame: Week 8
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.
Week 8
Change in Hamilton Depression Rating Scale (HAM-D) Total Score
Time Frame: Weeks 1 through Week 8
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.
Weeks 1 through Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2006

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A0081103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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