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

Condition(s) targeted: General Anxiety Disorder

Intervention: pregabalin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

Official title: An 8-Week Double-Blind, Placebo-Controlled, Phase 3 Trial of Pregabalin (150 - 600 mg/Day) in the Treatment of Patients With Generalized Anxiety Disorder (GAD)

Study design: Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study

Primary outcome:

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.

Secondary outcome:

HAM-A changes from baseline by week

HAM-A responders (greater than/equal to 50% decrease in total HAM-A scores from baseline through Week 8)

Time to onset of sustained HAM-A improvement (greater than/equal to 50% reduction in HAM-A score from baseline)

HAM-A Psychic Anxiety and Somatic subscale changes

Remission rate (HAM-A less than/equal to 7) in subjects at last study week

Hamilton Depression Rating Scale score change from baseline through week 8

Sheehan Disability Scale (SDS) total and domain scale change from baseline

Changes in the Daily Diary and Daily Assessment of Symptoms-Anxiety (DAS-A) and Global Anxiety-Visual Analogue Scale (GA-VAS) component and total scores from baseline

CGI-S at the subject's last study week

CGI-I responders (CGI-I greater than/equal to 2, much improved or very much improved) at the subject's last study week.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adult male and female subjects with primary DSM-IV diagnosis of GAD, as confirmed by

the MINI structured interview.

Exclusion Criteria:

- Current primary DSM-IV diagnosis of major depressive disorder with or without seasonal

pattern, dysthmic disorder, depressive disorder NOS, 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.

- 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).

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Praha 2 120 00, Czech Republic; Recruiting

Pfizer Investigational Site, Litomerice 412 01, Czech Republic; Recruiting

Pfizer Investigational Site, Brno 602 00, Czech Republic; Recruiting

Pfizer Investigational Site, Praha 6 163 00, Czech Republic; Recruiting

Pfizer Investigational Site, Praha 5 158 00, Czech Republic; Recruiting

Pfizer Investigational Site, Praha 8 - Bohnice 181 03, Czech Republic; Recruiting

Pfizer Investigational Site, Tallinn 10614, Estonia; Recruiting

Pfizer Investigational Site, Tartu 50417, Estonia; Recruiting

Pfizer Investigational Site, Kuopio 70110, Finland; Recruiting

Pfizer Investigational Site, Joensuu 80100, Finland; Recruiting

Pfizer Investigational Site, Helsinki 00029 HUS, Finland; Recruiting

Pfizer Investigational Site, Budapest 1083, Hungary; Recruiting

Pfizer Investigational Site, Gyor 9024, Hungary; Not yet recruiting

Pfizer Investigational Site, Pecs 7623, Hungary; Not yet recruiting

Pfizer Investigational Site, Budapest 1137, Hungary; Recruiting

Pfizer Investigational Site, Tg.Mures 540139, Romania; Not yet recruiting

Pfizer Investigational Site, Bucuresti 050524, Romania; Not yet recruiting

Pfizer Investigational Site, Moscow 119034, Russian Federation; Recruiting

Pfizer Investigational Site, Moscow 123367, Russian Federation; Recruiting

Pfizer Investigational Site, Moscow 115522, Russian Federation; Recruiting

Pfizer Investigational Site, St Petersburg 190121, Russian Federation; Recruiting

Pfizer Investigational Site, St. Petersburg 192019, Russian Federation; Recruiting

Pfizer Investigational Site, St. Petersburg 191180, Russian Federation; Recruiting

Pfizer Investigational Site, Belgrade, Serbia and Montenegro; Recruiting

Pfizer Investigational Site, Belgrde 11 000, Serbia and Montenegro; Recruiting

Pfizer Investigational Site, Kyiv 01030, Ukraine; Recruiting

Pfizer Investigational Site, Dnipropetrovsk 49005, Ukraine; Not yet recruiting

Pfizer Investigational Site, Lviv 79021, Ukraine; Recruiting

Pfizer Investigational Site, Dnipropetrovsk 49115, Ukraine; Recruiting

Pfizer Investigational Site, Donetsk 83037, Ukraine; Recruiting

Pfizer Investigational Site, Lugansk 91045, Ukraine; Recruiting

Pfizer Investigational Site, Sherman Oaks, California 91403, United States; Recruiting

Pfizer Investigational Site, Redlands, California 92374, United States; Recruiting

Pfizer Investigational Site, Arcadia, California 91007-3462, United States; Recruiting

Pfizer Investigational Site, Burbank, California 91506, United States; Recruiting

Pfizer Investigational Site, Norwich, Connecticut 06360, United States; Recruiting

Pfizer Investigational Site, Destin, Florida 32541, United States; Active, not recruiting

Pfizer Investigational Site, Fort Walton Beach, Florida 32547, United States; Active, not recruiting

Pfizer Investigational Site, Miami, Florida 33143, United States; Recruiting

Pfizer Investigational Site, South Miami, Florida 33143, United States; Recruiting

Pfizer Investigational Site, Iasi, Jud. Iasi 700282, Romania; Not yet recruiting

Pfizer Investigational Site, Wichita, Kansas 67207, United States; Recruiting

Pfizer Investigational Site, Overland Park, Kansas 66212, United States; Recruiting

Pfizer Investigational Site, Shreveport, Louisiana 71101, United States; Recruiting

Pfizer Investigational Site, Shreveport, Louisiana 71104, United States; Recruiting

Pfizer Investigational Site, Baltimore, Maryland 21208, United States; Recruiting

Pfizer Investigational Site, Boston, Massachusetts 02114, United States; Recruiting

Pfizer Investigational Site, Olive Branch, Mississippi 38654, United States; Recruiting

Pfizer Investigational Site, St. Charles, Missouri 63301, United States; Recruiting

Pfizer Investigational Site, Omaha, Nebraska 68131, United States; Recruiting

Pfizer Investigational Site, Clementon, New Jersey 08021, United States; Recruiting

Pfizer Investigational Site, Albuquerque, New Mexico 87102, United States; Recruiting

Pfizer Investigational Site, New York, New York 10128-1708, United States; Recruiting

Pfizer Investigational Site, Beachwood, Ohio 44122, United States; Recruiting

Pfizer Investigational Site, Cincinnati, Ohio 45227, United States; Recruiting

Pfizer Investigational Site, Cleveland, Ohio 44109-1998, United States; Recruiting

Pfizer Investigational Site, Bala Cynwyd, Pennsylvania 19004, United States; Recruiting

Pfizer Investigational Site, Media, Pennsylvania 19063, United States; Recruiting

Pfizer Investigational Site, Philadelphia, Pennsylvania 19104-3309, United States; Recruiting

Pfizer Investigational Site, Philadelphia, Pennsylvania 19136, United States; Recruiting

Pfizer Investigational Site, Belgrade, Serbia 11000, Serbia and Montenegro; Recruiting

Pfizer Investigational Site, Kragujevac, Serbia 34000, Serbia and Montenegro; Recruiting

Pfizer Investigational Site, Columbia, South Carolina 29201, United States; Recruiting

Pfizer Investigational Site, Memphis, Tennessee 38117, United States; Recruiting

Pfizer Investigational Site, Memphis, Tennessee 38133, United States; Recruiting

Pfizer Investigational Site, Houston, Texas 77057, United States; Recruiting

Pfizer Investigational Site, Houston, Texas 77074, United States; Recruiting

Pfizer Investigational Site, Lake Jackson, Texas 77566, United States; Recruiting

Pfizer Investigational Site, Houston, Texas 77008, United States; Recruiting

Pfizer Investigational Site, Viljandi, Viljandi mk. 71024, Estonia; Recruiting

Pfizer Investigational Site, Waukesha, Wisconsin 53188-1660, United States; Recruiting

To obtain contact information for a study center near you, click here.

Starting date: December 2006
Last updated: January 9, 2008