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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Generalized Anxiety Disorder

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

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

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

Summary

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).

Clinical Details

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:

Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1

Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2

Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1

Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2

Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1

Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2

Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1

Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2

Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1

Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2

Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1

Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2

Secondary outcome:

Number of Participants With Rebound Anxiety for Cohort 1 (Less Than 3-Month Last Visit)

Number of Participants With Rebound Anxiety for Cohort 2 (3-Month Last Visit)

Number of Participants With Rebound Anxiety for Cohort 3 (6-Month Last Visit)

Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 1 (Less Than 3-Month Last Visit)

Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 2 (3-Month Last Visit)

Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 3 (6-Month Last Visit)

Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 and 2

Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 and 2

Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 and 2

Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit)

Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit)

Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit)

Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 and 2

Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 and 2

Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 and 2

Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit)

Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit)

Hamilton Anxiety Scale (HAM-A) Score for Cohort 3 (6-Month Last Visit)

Hamilton Anxiety Scale (HAM-A) Score for Period 1

Hamilton Anxiety Scale (HAM-A) Score for Period 2

Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 12

Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 24

Clinical Global Impression - Severity (CGI-S) Score for Period 1

Clinical Global Impression - Severity (CGI-S) Score for Period 2

Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12

Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 24

Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 1

Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 2

Eligibility

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

Locations and Contacts

Pfizer Investigational Site, Buenos Aires C1405BOA, Argentina

Pfizer Investigational Site, Buenos Aires C1428AQK, Argentina

Pfizer Investigational Site, Buenos Aires C1115AAJ, Argentina

Pfizer Investigational Site, Wien A-1010, Austria

Pfizer Investigational Site, Wien A-1090, Austria

Pfizer Investigational Site, San Jose, Costa Rica

Pfizer Investigational Site, San Jose 00000, Costa Rica

Pfizer Investigational Site, Rijeka 51000, Croatia

Pfizer Investigational Site, Split 21000, Croatia

Pfizer Investigational Site, Zagreb 10000, Croatia

Pfizer Investigational Site, Brno 602 00, Czech Republic

Pfizer Investigational Site, Ceske Budejovice 370 87, Czech Republic

Pfizer Investigational Site, Litomerice 412 01, Czech Republic

Pfizer Investigational Site, Lnare 387 42, Czech Republic

Pfizer Investigational Site, Melnik 276 01, Czech Republic

Pfizer Investigational Site, Praha 10- Strasnice 10000, Czech Republic

Pfizer Investigational Site, Praha 2 120 00, Czech Republic

Pfizer Investigational Site, Praha 6 160 00, Czech Republic

Pfizer Investigational Site, Strakonice 386 01, Czech Republic

Pfizer Investigational Site, Espoo 02650, Finland

Pfizer Investigational Site, HUS 00029, Finland

Pfizer Investigational Site, Joensuu 80100, Finland

Pfizer Investigational Site, Kuopio 70110, Finland

Pfizer Investigational Site, Seinajoki 60100, Finland

Pfizer Investigational Site, Turku 20100, Finland

Pfizer Investigational Site, Athens 11528, Greece

Pfizer Investigational Site, Surabaya, Indonesia

Pfizer Investigational Site, Kaunas 50185, Lithuania

Pfizer Investigational Site, Kaunas 50425, Lithuania

Pfizer Investigational Site, Klaipeda 94231, Lithuania

Pfizer Investigational Site, Vilnius 09112, Lithuania

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

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

Pfizer Investigational Site, Moscow 107076, Russian Federation

Pfizer Investigational Site, Moscow 125367, Russian Federation

Pfizer Investigational Site, Moscow 119021, Russian Federation

Pfizer Investigational Site, Moscow 115522, Russian Federation

Pfizer Investigational Site, St. Petersburg 192019, Russian Federation

Pfizer Investigational Site, Belgrade 11000, Serbia

Pfizer Investigational Site, Kragujevac 34000, Serbia

Pfizer Investigational Site, Ljubljana, Slovenia

Pfizer Investigational Site, Zamora 49021, Spain

Pfizer Investigational Site, Istanbul 34203, Turkey

Pfizer Investigational Site, Kocaeli 41380, Turkey

Pfizer Investigational Site, Ellisbridge, Ahmedabad 380 006, India

Pfizer Investigational Site, Tirupati, Andhra Pradesh 517 507, India

Pfizer Investigational Site, Langreo, Asturias 33900, Spain

Pfizer Investigational Site, Denpasar, Bali, Indonesia

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

Pfizer Investigational Site, Acapulco, Guerrero 39670, Mexico

Pfizer Investigational Site, Jakarta Selatan, Jakarta 10430, Indonesia

Pfizer Investigational Site, Jakarta, Jakarta Selatan, Indonesia

Pfizer Investigational Site, Zapopan, Jalisco 45170, Mexico

Pfizer Investigational Site, Mangalore, Karnataka 575001, India

Pfizer Investigational Site, Pune, Maharashtra 411 030, India

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

Pfizer Investigational Site, Chennai, Tamil Nadu 600 003, India

Additional Information

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

Starting date: May 2009
Last updated: March 5, 2013

Page last updated: August 23, 2015

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