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

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

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).

Study Overview

• Status: Completed
• Conditions: Generalized Anxiety Disorder
• Intervention / Treatment: Drug: Placebo; Drug: Pregabalin; Drug: Pregabalin; Drug: Lorazepam

• Study Type: Interventional
• Enrollment (Actual): 615
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1115AAJ
    • Pfizer Investigational Site
  • Buenos Aires, Argentina, C1405BOA
    • Pfizer Investigational Site
  • Buenos Aires, Argentina, C1428AQK
    • Pfizer Investigational Site
  • Buenos Aires
    • La Plata, Buenos Aires, Argentina, B1904ADM
      • Pfizer Investigational Site
  • Prov. De Buenos Aires
    • Lanus, Prov. De Buenos Aires, Argentina, B1824IBR
      • Pfizer Investigational Site
• Austria
  • Wien, Austria, A-1090
    • Pfizer Investigational Site
  • Wien, Austria, A-1010
    • Pfizer Investigational Site
• Costa Rica
  • San Jose, Costa Rica
    • Pfizer Investigational Site
  • San Jose, Costa Rica, 00000
    • Pfizer Investigational Site
• Croatia
  • Rijeka, Croatia, 51000
    • Pfizer Investigational Site
  • Split, Croatia, 21000
    • Pfizer Investigational Site
  • Zagreb, Croatia, 10000
    • Pfizer Investigational Site
• Czechia
  • Brno, Czechia, 602 00
    • Pfizer Investigational Site
  • Ceske Budejovice, Czechia, 370 87
    • Pfizer Investigational Site
  • Litomerice, Czechia, 412 01
    • Pfizer Investigational Site
  • Lnare, Czechia, 387 42
    • Pfizer Investigational Site
  • Melnik, Czechia, 276 01
    • Pfizer Investigational Site
  • Praha 10- Strasnice, Czechia, 10000
    • Pfizer Investigational Site
  • Praha 2, Czechia, 120 00
    • Pfizer Investigational Site
  • Praha 6, Czechia, 160 00
    • Pfizer Investigational Site
  • Strakonice, Czechia, 386 01
    • Pfizer Investigational Site
• Finland
  • Espoo, Finland, 02650
    • Pfizer Investigational Site
  • HUS, Finland, 00029
    • Pfizer Investigational Site
  • Joensuu, Finland, 80100
    • Pfizer Investigational Site
  • Kuopio, Finland, 70110
    • Pfizer Investigational Site
  • Seinajoki, Finland, 60100
    • Pfizer Investigational Site
  • Turku, Finland, 20100
    • Pfizer Investigational Site
• Greece
  • Athens, Greece, 11528
    • Pfizer Investigational Site
• India
  • Ahmedabad
    • Ellisbridge, Ahmedabad, India, 380 006
      • Pfizer Investigational Site
  • Andhra Pradesh
    • Tirupati, Andhra Pradesh, India, 517 507
      • Pfizer Investigational Site
  • Karnataka
    • Mangalore, Karnataka, India, 575001
      • Pfizer Investigational Site
  • Maharashtra
    • Pune, Maharashtra, India, 411 030
      • Pfizer Investigational Site
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600 003
      • Pfizer Investigational Site
• Indonesia
  • Surabaya, Indonesia
    • Pfizer Investigational Site
  • Bali
    • Denpasar, Bali, Indonesia
      • Pfizer Investigational Site
  • Jakarta
    • Jakarta Selatan, Jakarta, Indonesia, 10430
      • Pfizer Investigational Site
  • Jakarta Selatan
    • Jakarta, Jakarta Selatan, Indonesia
      • Pfizer Investigational Site
• Lithuania
  • Kaunas, Lithuania, 50425
    • Pfizer Investigational Site
  • Kaunas, Lithuania, 50185
    • Pfizer Investigational Site
  • Klaipeda, Lithuania, 94231
    • Pfizer Investigational Site
  • Vilnius, Lithuania, 09112
    • Pfizer Investigational Site
• Mexico
  • Mexico D.F., Mexico, 14269
    • Pfizer Investigational Site
  • Guerrero
    • Acapulco, Guerrero, Mexico, 39670
      • Pfizer Investigational Site
  • Jalisco
    • Zapopan, Jalisco, Mexico, 45170
      • Pfizer Investigational Site
• Russian Federation
  • Khotkovo, Moscow Region, Russian Federation, 142601
    • Pfizer Investigational Site
  • Moscow, Russian Federation, 115522
    • Pfizer Investigational Site
  • Moscow, Russian Federation, 107076
    • Pfizer Investigational Site
  • Moscow, Russian Federation, 119021
    • Pfizer Investigational Site
  • Moscow, Russian Federation, 125367
    • Pfizer Investigational Site
  • St. Petersburg, Russian Federation, 192019
    • Pfizer Investigational Site
• Serbia
  • Belgrade, Serbia, 11000
    • Pfizer Investigational Site
  • Kragujevac, Serbia, 34000
    • Pfizer Investigational Site
• Slovenia
  • Ljubljana, Slovenia
    • Pfizer Investigational Site
• Spain
  • Zamora, Spain, 49021
    • Pfizer Investigational Site
  • Asturias
    • Langreo, Asturias, Spain, 33900
      • Pfizer Investigational Site
• Turkey
  • Istanbul, Turkey, 34203
    • Pfizer Investigational Site
  • Kocaeli, Turkey, 41380
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Pregabalin; Pregabalin 150-300 mg given twice a day; Other Names: Lyrica; Drug: Pregabalin; Pregabalin 450-600 mg given twice a day; Other Names: Lyrica
Active Comparator: 2	Drug: Lorazepam; Lorazepam 3-4 mg given twice a day
Experimental: 3	Drug: Pregabalin; Pregabalin 150-300 mg given twice a day; Other Names: Lyrica; Drug: Pregabalin; Pregabalin 450-600 mg given twice a day; Other Names: Lyrica
Placebo Comparator: 4	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1	HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.	Baseline, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9)
Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2	HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.	Baseline, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)
Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1	HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.	Baseline, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2	HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.	Baseline, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1	HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.	Baseline, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2	HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected.	Baseline, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
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	PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.	Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9)
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	PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.	Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)
Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1	PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.	Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2	PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.	Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1	PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.	Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2	PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.	Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Rebound Anxiety for Cohort 1 (Less Than 3-Month Last Visit)	Rebound anxiety was defined as a rapid return of the participant's original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value.	2 weeks post-treatment discontinuation (discontinuation occurred prior to Week 9)
Number of Participants With Rebound Anxiety for Cohort 2 (3-Month Last Visit)	Rebound anxiety was defined as a rapid return of the participant's original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value.	2 weeks post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
Number of Participants With Rebound Anxiety for Cohort 3 (6-Month Last Visit)	Rebound anxiety was defined as a rapid return of the participant's original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value.	2 weeks post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 1 (Less Than 3-Month Last Visit)	DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2.	2 weeks post-treatment discontinuation (discontinuation occurred prior to Week 9)
Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 2 (3-Month Last Visit)	DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2.	2 weeks post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 3 (6-Month Last Visit)	DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2.	2 weeks post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
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	PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.	Baseline, Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)
Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 and 2	PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.	Baseline, Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 and 2	PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.	Baseline, Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24)
Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit)	PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.	Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)
Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit)	PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.	Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit)	PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.	Week 1, 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
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	HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.	Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)
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	HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected.	Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
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	HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.	Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24)
Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit)	HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.	Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)
Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit)	HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected.	Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
Hamilton Anxiety Scale (HAM-A) Score for Cohort 3 (6-Month Last Visit)	HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.	Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24)
Hamilton Anxiety Scale (HAM-A) Score for Period 1	HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.	Baseline, Week 12
Hamilton Anxiety Scale (HAM-A) Score for Period 2	HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.	Baseline, Week 24
Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 12	HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.	Baseline, Week 12
Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 24	HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.	Baseline, Week 24
Clinical Global Impression - Severity (CGI-S) Score for Period 1	CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.	Baseline, Week 12
Clinical Global Impression - Severity (CGI-S) Score for Period 2	CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected	Baseline, Week 24
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12	CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.	Baseline, Week 12
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 24	CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected	Baseline, Week 24
Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 1	CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.	Week 12
Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 2	CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.	Week 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sheehan-Suicidality Tracking Scale (S-STS) Score	Sheehan-Suicidality Tracking Scale (S-STS): an 8-item prospective rating scale that tracked treatment-emergent suicidal ideation and behaviors. Items 1a, 2-6, 7a, and 8 were scored on a 5-point Likert scale (ranging from 0= not at all to 4=extremely). Items 1, 1b, and 7 required yes or no responses. Total score ranged from 0 to 35, higher score indicated higher suicidal tendency.	Baseline up to Week 24
Number of Participants With Treatment-Emergent Adverse Events (AEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and Week 12, for period 1, and between Week 13 and Week 24, for period 2, that were absent before treatment or that worsened relative to pretreatment state.	Baseline up to Week 12 (period 1), Week 13 up to Week 24 (period 2)

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: February 15, 2008
• First Submitted That Met QC Criteria: February 15, 2008
• First Posted (Estimate): February 27, 2008

Study Record Updates

• Last Update Posted (Actual): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Antiemetics; Gastrointestinal Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Hypnotics and Sedatives; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin; Lorazepam
• Other Study ID Numbers: A0081147