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

NCT ID: NCT00413010

Last Updated: 2021-02-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

356 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Generalized Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo + concurrent GAD treatment from the open-label study period

Arm 1

Group Type EXPERIMENTAL

pregabalin

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

placebo

placebo + concurrent GAD treatment from the open-label study period

Intervention Type DRUG

Other Intervention Names

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Lyrica

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Arcadia, California, United States

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Burbank, California, United States

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Redlands, California, United States

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Sherman Oaks, California, United States

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Norwich, Connecticut, United States

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Destin, Florida, United States

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Fort Walton Beach, Florida, United States

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Miami, Florida, United States

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South Miami, Florida, United States

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Overland Park, Kansas, United States

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Wichita, Kansas, United States

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Shreveport, Louisiana, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Olive Branch, Mississippi, United States

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Saint Charles, Missouri, United States

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Omaha, Nebraska, United States

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Clementon, New Jersey, United States

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Albuquerque, New Mexico, United States

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New York, New York, United States

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Beachwood, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Bala-Cynwyd, Pennsylvania, United States

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Media, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Columbia, South Carolina, United States

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Memphis, Tennessee, United States

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Memphis, Tennessee, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Lake Jackson, Texas, United States

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Waukesha, Wisconsin, United States

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Brno, , Czechia

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Litoměřice, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Praha 8 - Bohnice, , Czechia

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Viljandi, Viljandi Mk., Estonia

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Tallinn, , Estonia

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Tartu, , Estonia

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Helsinki, , Finland

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Joensuu, , Finland

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Kuopio, , Finland

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Budapest, , Hungary

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Budapest, , Hungary

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Pécs, , Hungary

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Smolensk, , Russia

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Smolensk, , Russia

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Belgrade, , Serbia

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Belgrade, , Serbia

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Belgrade, , Serbia

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Kragujevac, , Serbia

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Dnipropetrovsk, , Ukraine

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Dnipropetrovsk, , Ukraine

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Donetsk, , Ukraine

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Kyiv, , Ukraine

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Luhansk, , Ukraine

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Lviv, , Ukraine

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Countries

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United States Czechia Estonia Finland Hungary Russia Serbia Ukraine

References

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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.

Reference Type DERIVED
PMID: 22302014 (View on PubMed)

Other Identifiers

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A0081103

Identifier Type: -

Identifier Source: org_study_id

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