Clinical trial NCT00413010: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Generalized Anxiety Disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-12-19
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Change in HAM-A Total Score at Weekly Visits
timeFrame: Baseline, Weeks 1 through Week 8
measure: Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: Weeks 1 through Week 8
measure: Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score
timeFrame: Week 1 through Week 8
measure: Time to Onset of Sustained Hamilton Anxiety Rating Scale (HAM-A) Improvement
timeFrame: Week 8
measure: Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score
timeFrame: Week 1 through Week 8
measure: Clinical Global Impression of Severity (CGI-S) Score
timeFrame: Week 8
measure: Change in Hamilton Depression Rating Scale (HAM-D) Total Score
timeFrame: Weeks 1 through Week 8
Other outcomes:
Locations:
city: Arcadia
country: United States
facility: Pfizer Investigational Site
state: California
city: Burbank
country: United States
facility: Pfizer Investigational Site
state: California
city: Redlands
country: United States
facility: Pfizer Investigational Site
state: California
city: Sherman Oaks
country: United States
facility: Pfizer Investigational Site
state: California
city: Norwich
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Destin
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Fort Walton Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: South Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Shreveport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Olive Branch
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Saint Charles
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Clementon
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Beachwood
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Bala-Cynwyd
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Media
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Lake Jackson
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Waukesha
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Brno
country: Czechia
facility: Pfizer Investigational Site
city: Litomerice
country: Czechia
facility: Pfizer Investigational Site
city: Praha 2
country: Czechia
facility: Pfizer Investigational Site
city: Praha 5
country: Czechia
facility: Pfizer Investigational Site
city: Praha 6
country: Czechia
facility: Pfizer Investigational Site
city: Praha 8 - Bohnice
country: Czechia
facility: Pfizer Investigational Site
city: Viljandi
country: Estonia
facility: Pfizer Investigational Site
state: Viljandi Mk.
city: Tallinn
country: Estonia
facility: Pfizer Investigational Site
city: Tartu
country: Estonia
facility: Pfizer Investigational Site
city: Helsinki
country: Finland
facility: Pfizer Investigational Site
city: Joensuu
country: Finland
facility: Pfizer Investigational Site
city: Kuopio
country: Finland
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Pecs
country: Hungary
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Smolensk
country: Russian Federation
facility: Pfizer Investigational Site
city: Smolensk
country: Russian Federation
facility: Pfizer Investigational Site
city: St Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Belgrade
country: Serbia
facility: Pfizer Investigational Site
city: Belgrade
country: Serbia
facility: Pfizer Investigational Site
city: Belgrade
country: Serbia
facility: Pfizer Investigational Site
city: Kragujevac
country: Serbia
facility: Pfizer Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: Pfizer Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: Pfizer Investigational Site
city: Donetsk
country: Ukraine
facility: Pfizer Investigational Site
city: Kyiv
country: Ukraine
facility: Pfizer Investigational Site
city: Lugansk
country: Ukraine
facility: Pfizer Investigational Site
city: Lviv
country: Ukraine
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.