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

Generalized Anxiety Disorder Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00413010
• Other study ID #: A0081103
• Status: Completed
• Phase: Phase 3
• Start date: December 2006
• Est. completion date: March 2008

Study information

• Verified date: December 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: March 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

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

Locations

Country	Name	City	State
Czechia	Pfizer Investigational Site	Brno
Czechia	Pfizer Investigational Site	Litomerice
Czechia	Pfizer Investigational Site	Praha 2
Czechia	Pfizer Investigational Site	Praha 5
Czechia	Pfizer Investigational Site	Praha 6
Czechia	Pfizer Investigational Site	Praha 8 - Bohnice
Estonia	Pfizer Investigational Site	Tallinn
Estonia	Pfizer Investigational Site	Tartu
Estonia	Pfizer Investigational Site	Viljandi	Viljandi Mk.
Finland	Pfizer Investigational Site	Helsinki
Finland	Pfizer Investigational Site	Joensuu
Finland	Pfizer Investigational Site	Kuopio
Hungary	Pfizer Investigational Site	Budapest
Hungary	Pfizer Investigational Site	Budapest
Hungary	Pfizer Investigational Site	Pecs
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Smolensk
Russian Federation	Pfizer Investigational Site	Smolensk
Russian Federation	Pfizer Investigational Site	St Petersburg
Russian Federation	Pfizer Investigational Site	St. Petersburg
Russian Federation	Pfizer Investigational Site	St. Petersburg
Serbia	Pfizer Investigational Site	Belgrade
Serbia	Pfizer Investigational Site	Belgrade
Serbia	Pfizer Investigational Site	Belgrade
Serbia	Pfizer Investigational Site	Kragujevac
Ukraine	Pfizer Investigational Site	Dnipropetrovsk
Ukraine	Pfizer Investigational Site	Dnipropetrovsk
Ukraine	Pfizer Investigational Site	Donetsk
Ukraine	Pfizer Investigational Site	Kyiv
Ukraine	Pfizer Investigational Site	Lugansk
Ukraine	Pfizer Investigational Site	Lviv
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Arcadia	California
United States	Pfizer Investigational Site	Bala-Cynwyd	Pennsylvania
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Beachwood	Ohio
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Burbank	California
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Clementon	New Jersey
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Columbia	South Carolina
United States	Pfizer Investigational Site	Destin	Florida
United States	Pfizer Investigational Site	Fort Walton Beach	Florida
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Lake Jackson	Texas
United States	Pfizer Investigational Site	Media	Pennsylvania
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Norwich	Connecticut
United States	Pfizer Investigational Site	Olive Branch	Mississippi
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Redlands	California
United States	Pfizer Investigational Site	Saint Charles	Missouri
United States	Pfizer Investigational Site	Sherman Oaks	California
United States	Pfizer Investigational Site	Shreveport	Louisiana
United States	Pfizer Investigational Site	Shreveport	Louisiana
United States	Pfizer Investigational Site	South Miami	Florida
United States	Pfizer Investigational Site	Waukesha	Wisconsin
United States	Pfizer Investigational Site	Wichita	Kansas

Sponsors (1)

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

Countries where clinical trial is conducted

United States,  Czechia,  Estonia,  Finland,  Hungary,  Russian Federation,  Serbia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 8 weeks
Secondary	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.	Baseline, Weeks 1 through Week 8
Secondary	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.	Weeks 1 through Week 8
Secondary	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.	Week 1 through Week 8
Secondary	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.	Week 8
Secondary	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).	Week 1 through Week 8
Secondary	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.	Week 8
Secondary	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.	Weeks 1 through Week 8