Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder

Condition(s) targeted: Generalized Anxiety Disorder

Intervention: Pregabalin (Drug); Lorazepam (Drug); Pregabalin (Drug); Placebo (Drug)

Phase: Phase 4

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 purpose of this study is to characterize the safety and efficacy in patients with generalized anxiety disorder after short- (3 months) and long-term (6 months) use of Pregabalin (Lyrica).

Official title: Long Term Safety And Efficacy Study Of Pregabalin (Lyrica) In Subjects With Generalized Anxiety Disorder

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Safety endpoints: Adverse events at 3 and 6 months, Physicians Withdrawal Checklist (PWC), Rebound Anxiety (HAM-A), Discontinuation Emergent Signs and Symptoms (DESS)

Efficacy endpoints: Hamilton Anxiety Scale (HAM-A), Clinical Global Impression-Severity (CGI-S), Clinical Global Impression-Improvement (CGI-I).

Secondary outcome:

Adverse events

Suicidality

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis Generalized Anxiety Disorder

- HAM-A score >=18 and HAM-D (item 1) score >=2 at screening and baseline

- Needs pharmacological treatment

Exclusion Criteria:

- Current or past diagnosis of any other DSM IV Axis I disorders

- A history of failed treatment with a benzodiazepine

- Any clinically significant, serious, or unstable hematologic, autoimmune, endocrine,

cardiovascular, renal, hepatic, gastrointestinal, or neurological disorder

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

Pfizer Investigational Site, Buenos Aires C1405BOA, Argentina; Completed

Pfizer Investigational Site, Buenos Aires C1115AAJ, Argentina; Completed

Pfizer Investigational Site, Buenos Aires C1428AQK, Argentina; Completed

Pfizer Investigational Site, Wien A-1090, Austria; Active, not recruiting

Pfizer Investigational Site, Wien A-1010, Austria; Active, not recruiting

Pfizer Investigational Site, San Jose, Costa Rica; Active, not recruiting

Pfizer Investigational Site, San Jose 00000, Costa Rica; Active, not recruiting

Pfizer Investigational Site, San Jose, Costa Rica; Completed

Pfizer Investigational Site, Rijeka 51000, Croatia; Recruiting

Pfizer Investigational Site, Split 21000, Croatia; Recruiting

Pfizer Investigational Site, Zagreb 10000, Croatia; Recruiting

Pfizer Investigational Site, Brno 602 00, Czech Republic; Active, not recruiting

Pfizer Investigational Site, Ceske Budejovice 370 87, Czech Republic; Active, not recruiting

Pfizer Investigational Site, Litomerice 412 01, Czech Republic; Active, not recruiting

Pfizer Investigational Site, Melnik 276 01, Czech Republic; Active, not recruiting

Pfizer Investigational Site, Praha 10- Strasnice 10000, Czech Republic; Active, not recruiting

Pfizer Investigational Site, Praha 2 120 00, Czech Republic; Active, not recruiting

Pfizer Investigational Site, Praha 6 160 00, Czech Republic; Active, not recruiting

Pfizer Investigational Site, Strakonice 386 01, Czech Republic; Active, not recruiting

Pfizer Investigational Site, HUS 00029, Finland; Completed

Pfizer Investigational Site, Joensuu 80100, Finland; Completed

Pfizer Investigational Site, Kuopio 70110, Finland; Active, not recruiting

Pfizer Investigational Site, Seinajoki 60100, Finland; Completed

Pfizer Investigational Site, Turku 20100, Finland; Completed

Pfizer Investigational Site, Athens 11528, Greece; Active, not recruiting

Pfizer Investigational Site, Surabaya, Indonesia; Terminated

Pfizer Investigational Site, Kaunas 50185, Lithuania; Recruiting

Pfizer Investigational Site, Kaunas 50425, Lithuania; Recruiting

Pfizer Investigational Site, Klaipeda 94231, Lithuania; Recruiting

Pfizer Investigational Site, Vilnius 09112, Lithuania; Recruiting

Pfizer Investigational Site, Mexico D.F. 14269, Mexico; Terminated

Pfizer Investigational Site, Khotkovo, Moscow region 142601, Russian Federation; Recruiting

Pfizer Investigational Site, Moscow 125367, Russian Federation; Recruiting

Pfizer Investigational Site, Moscow 119021, Russian Federation; Recruiting

Pfizer Investigational Site, Moscow 115522, Russian Federation; Recruiting

Pfizer Investigational Site, Moscow 115522, Russian Federation; Active, not recruiting

Pfizer Investigational Site, Moscow 107076, Russian Federation; Active, not recruiting

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

Pfizer Investigational Site, Belgrade 11000, Serbia; Recruiting

Pfizer Investigational Site, Belgrade 11000, Serbia; Active, not recruiting

Pfizer Investigational Site, Kragujevac 34000, Serbia; Active, not recruiting

Pfizer Investigational Site, Ljubljana, Slovenia; Active, not recruiting

Pfizer Investigational Site, Zamora 49021, Spain; Active, not recruiting

Pfizer Investigational Site, Istanbul 34203, Turkey; Active, not recruiting

Pfizer Investigational Site, Kocaeli 41380, Turkey; Active, not recruiting

Pfizer Investigational Site, Espoo, 02650, Finland; Completed

Pfizer Investigational Site, Lnare, 387 42, Czech Republic; Active, not recruiting

Pfizer Investigational Site, Ellisbridge, Ahmedabad 380 006, India; Recruiting

Pfizer Investigational Site, Tirupati, Andhra Pradesh 517 507, India; Active, not recruiting

Pfizer Investigational Site, Langreo, Asturias 33900, Spain; Active, not recruiting

Pfizer Investigational Site, Denpasar, Bali, Indonesia; Terminated

Pfizer Investigational Site, La Plata, Buenos Aires B1904ADM, Argentina; Completed

Pfizer Investigational Site, Acapulco, Guerrero 39670, Mexico; Active, not recruiting

Pfizer Investigational Site, Jakarta Selatan, Jakarta 10430, Indonesia; Terminated

Pfizer Investigational Site, Jakarta, Jakarta Selatan, Indonesia; Terminated

Pfizer Investigational Site, Zapopan, Jalisco 45170, Mexico; Active, not recruiting

Pfizer Investigational Site, Mangalore, Karnataka 575001, India; Active, not recruiting

Pfizer Investigational Site, Pune, Maharashtra 411 030, India; Recruiting

Pfizer Investigational Site, Lanus, Prov. de Buenos Aires B1824IBR, Argentina; Completed

Pfizer Investigational Site, Chennai, Tamil Nadu 600 003, India; Active, not recruiting

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

Starting date: May 2009
Last updated: November 17, 2011