Clinical trial NCT00624780: Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder
Official title: Long Term Safety And Efficacy Study Of Pregabalin (Lyrica) In Subjects With Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Generalized Anxiety Disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-02-27
Enrollment: 615
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1
timeFrame: Baseline, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9)
measure: Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2
timeFrame: Baseline, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)
measure: Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1
timeFrame: Baseline, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
measure: Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2
timeFrame: Baseline, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
measure: Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1
timeFrame: Baseline, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
measure: Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2
timeFrame: Baseline, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
measure: 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
timeFrame: Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9)
measure: 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
timeFrame: Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)
measure: Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1
timeFrame: Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
measure: Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2
timeFrame: Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
measure: Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1
timeFrame: Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
measure: Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2
timeFrame: Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
Secondary outcomes:
measure: Number of Participants With Rebound Anxiety for Cohort 1 (Less Than 3-Month Last Visit)
timeFrame: 2 weeks post-treatment discontinuation (discontinuation occurred prior to Week 9)
measure: Number of Participants With Rebound Anxiety for Cohort 2 (3-Month Last Visit)
timeFrame: 2 weeks post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
measure: Number of Participants With Rebound Anxiety for Cohort 3 (6-Month Last Visit)
timeFrame: 2 weeks post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
measure: Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 1 (Less Than 3-Month Last Visit)
timeFrame: 2 weeks post-treatment discontinuation (discontinuation occurred prior to Week 9)
measure: Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 2 (3-Month Last Visit)
timeFrame: 2 weeks post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
measure: Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 3 (6-Month Last Visit)
timeFrame: 2 weeks post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
measure: 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
timeFrame: Baseline, Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)
measure: Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 and 2
timeFrame: Baseline, Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
measure: Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 and 2
timeFrame: Baseline, Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24)
measure: Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit)
timeFrame: Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)
measure: Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit)
timeFrame: Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
measure: Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit)
timeFrame: Week 1, 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
measure: 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
timeFrame: Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)
measure: 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
timeFrame: Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
measure: 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
timeFrame: Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24)
measure: Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit)
timeFrame: Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)
measure: Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit)
timeFrame: Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
measure: Hamilton Anxiety Scale (HAM-A) Score for Cohort 3 (6-Month Last Visit)
timeFrame: Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24)
measure: Hamilton Anxiety Scale (HAM-A) Score for Period 1
timeFrame: Baseline, Week 12
measure: Hamilton Anxiety Scale (HAM-A) Score for Period 2
timeFrame: Baseline, Week 24
measure: Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 24
timeFrame: Baseline, Week 24
measure: Clinical Global Impression - Severity (CGI-S) Score for Period 1
timeFrame: Baseline, Week 12
measure: Clinical Global Impression - Severity (CGI-S) Score for Period 2
timeFrame: Baseline, Week 24
measure: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 24
timeFrame: Baseline, Week 24
measure: Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 1
timeFrame: Week 12
measure: Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 2
timeFrame: Week 24
Other outcomes:
measure: Sheehan-Suicidality Tracking Scale (S-STS) Score
timeFrame: Baseline up to Week 24
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs)
timeFrame: Baseline up to Week 12 (period 1), Week 13 up to Week 24 (period 2)
Locations:
city: La Plata
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Lanus
country: Argentina
facility: Pfizer Investigational Site
state: Prov. De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: San Jose
country: Costa Rica
facility: Pfizer Investigational Site
city: San Jose
country: Costa Rica
facility: Pfizer Investigational Site
city: Rijeka
country: Croatia
facility: Pfizer Investigational Site
city: Split
country: Croatia
facility: Pfizer Investigational Site
city: Zagreb
country: Croatia
facility: Pfizer Investigational Site
city: Brno
country: Czechia
facility: Pfizer Investigational Site
city: Ceske Budejovice
country: Czechia
facility: Pfizer Investigational Site
city: Litomerice
country: Czechia
facility: Pfizer Investigational Site
city: Lnare
country: Czechia
facility: Pfizer Investigational Site
city: Melnik
country: Czechia
facility: Pfizer Investigational Site
city: Praha 10- Strasnice
country: Czechia
facility: Pfizer Investigational Site
city: Praha 2
country: Czechia
facility: Pfizer Investigational Site
city: Praha 6
country: Czechia
facility: Pfizer Investigational Site
city: Strakonice
country: Czechia
facility: Pfizer Investigational Site
city: Espoo
country: Finland
facility: Pfizer Investigational Site
city: HUS
country: Finland
facility: Pfizer Investigational Site
city: Joensuu
country: Finland
facility: Pfizer Investigational Site
city: Kuopio
country: Finland
facility: Pfizer Investigational Site
city: Seinajoki
country: Finland
facility: Pfizer Investigational Site
city: Turku
country: Finland
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Ellisbridge
country: India
facility: Pfizer Investigational Site
state: Ahmedabad
city: Tirupati
country: India
facility: Pfizer Investigational Site
state: Andhra Pradesh
city: Mangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Pune
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Chennai
country: India
facility: Pfizer Investigational Site
state: Tamil Nadu
city: Denpasar
country: Indonesia
facility: Pfizer Investigational Site
state: Bali
city: Jakarta
country: Indonesia
facility: Pfizer Investigational Site
state: Jakarta Selatan
city: Jakarta Selatan
country: Indonesia
facility: Pfizer Investigational Site
state: Jakarta
city: Surabaya
country: Indonesia
facility: Pfizer Investigational Site
city: Kaunas
country: Lithuania
facility: Pfizer Investigational Site
city: Kaunas
country: Lithuania
facility: Pfizer Investigational Site
city: Klaipeda
country: Lithuania
facility: Pfizer Investigational Site
city: Vilnius
country: Lithuania
facility: Pfizer Investigational Site
city: Acapulco
country: Mexico
facility: Pfizer Investigational Site
state: Guerrero
city: Zapopan
country: Mexico
facility: Pfizer Investigational Site
state: Jalisco
city: Mexico D.F.
country: Mexico
facility: Pfizer Investigational Site
city: Khotkovo, Moscow Region
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: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
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: Kragujevac
country: Serbia
facility: Pfizer Investigational Site
city: Ljubljana
country: Slovenia
facility: Pfizer Investigational Site
city: Langreo
country: Spain
facility: Pfizer Investigational Site
state: Asturias
city: Zamora
country: Spain
facility: Pfizer Investigational Site
city: Istanbul
country: Turkey
facility: Pfizer Investigational Site
city: Kocaeli
country: Turkey
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Kasper S, Iglesias-Garcia C, Schweizer E, Wilson J, DuBrava S, Prieto R, Pitman VW, Knapp L. Pregabalin long-term treatment and assessment of discontinuation in patients with generalized anxiety disorder. Int J Neuropsychopharmacol. 2014 May;17(5):685-95. doi: 10.1017/S1461145713001557. Epub 2013 Dec 19.