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

Generalized Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00624780
• Other study ID #: A0081147
• Status: Completed
• Phase: Phase 4
• Start date: May 2009
• Est. completion date: April 2012

Study information

• Verified date: September 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 615
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Drug:
• Pregabalin
Pregabalin 150-300 mg given twice a day
• Lorazepam
Lorazepam 3-4 mg given twice a day
• Pregabalin
Pregabalin 450-600 mg given twice a day
• Placebo
Placebo

Locations

Country	Name	City	State
Argentina	Pfizer Investigational Site	Buenos Aires
Argentina	Pfizer Investigational Site	Buenos Aires
Argentina	Pfizer Investigational Site	Buenos Aires
Argentina	Pfizer Investigational Site	La Plata	Buenos Aires
Argentina	Pfizer Investigational Site	Lanus	Prov. De Buenos Aires
Austria	Pfizer Investigational Site	Wien
Austria	Pfizer Investigational Site	Wien
Costa Rica	Pfizer Investigational Site	San Jose
Costa Rica	Pfizer Investigational Site	San Jose
Croatia	Pfizer Investigational Site	Rijeka
Croatia	Pfizer Investigational Site	Split
Croatia	Pfizer Investigational Site	Zagreb
Czechia	Pfizer Investigational Site	Brno
Czechia	Pfizer Investigational Site	Ceske Budejovice
Czechia	Pfizer Investigational Site	Litomerice
Czechia	Pfizer Investigational Site	Lnare
Czechia	Pfizer Investigational Site	Melnik
Czechia	Pfizer Investigational Site	Praha 10- Strasnice
Czechia	Pfizer Investigational Site	Praha 2
Czechia	Pfizer Investigational Site	Praha 6
Czechia	Pfizer Investigational Site	Strakonice
Finland	Pfizer Investigational Site	Espoo
Finland	Pfizer Investigational Site	HUS
Finland	Pfizer Investigational Site	Joensuu
Finland	Pfizer Investigational Site	Kuopio
Finland	Pfizer Investigational Site	Seinajoki
Finland	Pfizer Investigational Site	Turku
Greece	Pfizer Investigational Site	Athens
India	Pfizer Investigational Site	Chennai	Tamil Nadu
India	Pfizer Investigational Site	Ellisbridge	Ahmedabad
India	Pfizer Investigational Site	Mangalore	Karnataka
India	Pfizer Investigational Site	Pune	Maharashtra
India	Pfizer Investigational Site	Tirupati	Andhra Pradesh
Indonesia	Pfizer Investigational Site	Denpasar	Bali
Indonesia	Pfizer Investigational Site	Jakarta	Jakarta Selatan
Indonesia	Pfizer Investigational Site	Jakarta Selatan	Jakarta
Indonesia	Pfizer Investigational Site	Surabaya
Lithuania	Pfizer Investigational Site	Kaunas
Lithuania	Pfizer Investigational Site	Kaunas
Lithuania	Pfizer Investigational Site	Klaipeda
Lithuania	Pfizer Investigational Site	Vilnius
Mexico	Pfizer Investigational Site	Acapulco	Guerrero
Mexico	Pfizer Investigational Site	Mexico D.F.
Mexico	Pfizer Investigational Site	Zapopan	Jalisco
Russian Federation	Pfizer Investigational Site	Khotkovo, Moscow Region
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	St. Petersburg
Serbia	Pfizer Investigational Site	Belgrade
Serbia	Pfizer Investigational Site	Kragujevac
Slovenia	Pfizer Investigational Site	Ljubljana
Spain	Pfizer Investigational Site	Langreo	Asturias
Spain	Pfizer Investigational Site	Zamora
Turkey	Pfizer Investigational Site	Istanbul
Turkey	Pfizer Investigational Site	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

Argentina,  Austria,  Costa Rica,  Croatia,  Czechia,  Finland,  Greece,  India,  Indonesia,  Lithuania,  Mexico,  Russian Federation,  Serbia,  Slovenia,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

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