Generalized Anxiety DisorderPhase 4NCT00624780

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

A Phase 4 study testing Pregabalin and Lorazepam in people with Generalized Anxiety Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 57 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Generalized Anxiety Disorder
What is being tested?: Pregabalin and Lorazepam
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 615 participants
Where: 57 sitesin 16 countries
Study dates: May 2009to Apr 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis Generalized Anxiety Disorder
HAM-A score >=18 and HAM-D (item 1) score >=2 at screening and baseline
Needs pharmacological treatment

Who cannot join

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

Trial locations and contacts

57 sites in 16 countries.

Country

City, postcode or hospital

57 sites in 16 countries

Czechia9 sites

Pfizer Investigational Site
Brno, 602 00
Pfizer Investigational Site
České Budějovice, 370 87
Pfizer Investigational Site
Litoměřice, 412 01
Pfizer Investigational Site
Lnáře, 387 42
Pfizer Investigational Site
Mělník, 276 01
Pfizer Investigational Site
Prague, 120 00
Pfizer Investigational Site
Prague, 160 00
Pfizer Investigational Site
Praha 10- Strasnice, 10000
Pfizer Investigational Site
Strakonice, 386 01

Other trials in Czechia

Finland6 sites

Pfizer Investigational Site
Espoo, 02650
Pfizer Investigational Site
HUS, 00029
Pfizer Investigational Site
Joensuu, 80100
Pfizer Investigational Site
Kuopio, 70110
Pfizer Investigational Site
Seinäjoki, 60100
Pfizer Investigational Site
Turku, 20100

Other trials in Finland

Russia6 sites

Pfizer Investigational Site
Khotkovo, Moscow Region, 142601
Pfizer Investigational Site
Moscow, 107076
Pfizer Investigational Site
Moscow, 115522
Pfizer Investigational Site
Moscow, 119021
Pfizer Investigational Site
Moscow, 125367
Pfizer Investigational Site
Saint Petersburg, 192019

Other trials in Russia

Argentina5 sites

Pfizer Investigational Site
Buenos Aires, C1115AAJ
Pfizer Investigational Site
Buenos Aires, C1405BOA
Pfizer Investigational Site
Buenos Aires, C1428AQK
Pfizer Investigational Site
La Plata, Buenos Aires, B1904ADM
Pfizer Investigational Site
Lanus, Prov. de Buenos Aires, B1824IBR

Other trials in Argentina

India5 sites

Pfizer Investigational Site
Chennai, Tamil Nadu, 600 003
Pfizer Investigational Site
Ellisbridge, Ahmedabad, 380 006
Pfizer Investigational Site
Mangalore, Karnataka, 575001
Pfizer Investigational Site
Pune, Maharashtra, 411 030
Pfizer Investigational Site
Tirupati, Andhra Pradesh, 517 507

Other trials in India

Indonesia4 sites

Pfizer Investigational Site
Denpasar, Bali
Pfizer Investigational Site
Jakarta, Jakarta Selatan
Pfizer Investigational Site
Jakarta Selatan, Jakarta Special Capital Region, 10430
Pfizer Investigational Site
Surabaya

Other trials in Indonesia

Lithuania4 sites

Pfizer Investigational Site
Kaunas, 50185
Pfizer Investigational Site
Kaunas, 50425
Pfizer Investigational Site
Klaipėda, 94231
Pfizer Investigational Site
Vilnius, 09112

Other trials in Lithuania

Croatia3 sites

Pfizer Investigational Site
Rijeka, 51000
Pfizer Investigational Site
Split, 21000
Pfizer Investigational Site
Zagreb, 10000

Other trials in Croatia

Mexico3 sites

Pfizer Investigational Site
Acapulco de Juárez, Guerrero, 39670
Pfizer Investigational Site
Mexico City, 14269
Pfizer Investigational Site
Zapopan, Jalisco, 45170

Other trials in Mexico

Austria2 sites

Pfizer Investigational Site
Vienna, A-1010
Pfizer Investigational Site
Vienna, A-1090

Other trials in Austria

Costa Rica2 sites

Pfizer Investigational Site
San José, 00000
Pfizer Investigational Site
San José

Other trials in Costa Rica

Serbia2 sites

Pfizer Investigational Site
Belgrade, 11000
Pfizer Investigational Site
Kragujevac, 34000

Other trials in Serbia

Spain2 sites

Pfizer Investigational Site
Langreo, Principality of Asturias, 33900
Pfizer Investigational Site
Zamora, 49021

Other trials in Spain

Turkey (Türkiye)2 sites

Pfizer Investigational Site
Istanbul, 34203
Pfizer Investigational Site
Kocaeli, 41380

Other trials in Turkey (Türkiye)

Greece1 site

Pfizer Investigational Site
Athens, 11528

Other trials in Greece

Slovenia1 site

Pfizer Investigational Site
Ljubljana

Other trials in Slovenia

About this study

Official title: 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).

Conditions: Generalized Anxiety Disorder
Being tested: Pregabalin, Lorazepam, Placebo
Medical subject headings: Generalized Anxiety Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PregabalinDrug
Also called Lyrica
Pregabalin 150-300 mg given twice a day
LorazepamDrug
Lorazepam 3-4 mg given twice a day
PregabalinDrug
Also called Lyrica
Pregabalin 450-600 mg given twice a day
PlaceboDrug
Placebo

Study groups in NCT00624780
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: Pregabalin
2	Active comparator	Not described Receives: Drug: Lorazepam
3	Experimental	Not described Receives: Drug: Pregabalin
4	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)

Secondary outcomes (28)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2009Apr 2012

First posted27 Feb 2008 (estimated)
Study startMay 2009
Primary completionApr 2012
Study completionApr 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 615 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00624780
Sponsor's protocol ID: A0081147
Status last verified: Sep 2012
First submitted: 15 Feb 2008
Last updated: 28 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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.
PubMed 24351233

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long Term Safety And Efficacy Study Of Pregabalin (Lyrica) In Subjects With Generalized Anxiety Disorder
ClinicalTrials.gov ID: NCT00624780
Acronym / sponsor ID: A0081147
Conditions: Generalized Anxiety Disorder
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 615 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: May 2009
Primary completion: Apr 2012 (actual)
Study completion: Apr 2012 (actual)
First posted: 27 Feb 2008 (estimated)
Results: Posted 19 Apr 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
1	Experimental	Drug: Pregabalin
2	Active comparator	Drug: Lorazepam
3	Experimental	Drug: Pregabalin
4	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Diagnosis Generalized Anxiety Disorder
HAM-A score >=18 and HAM-D (item 1) score >=2 at screening and baseline
Needs pharmacological treatment

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PregabalinAlso: LyricaPregabalin 150-300 mg given twice a day	Drug	1
LorazepamLorazepam 3-4 mg given twice a day	Drug	2
PregabalinAlso: LyricaPregabalin 450-600 mg given twice a day	Drug	3
PlaceboPlacebo	Drug	4

Primary outcome

Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1
Time frame: Baseline, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9)
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.
Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2
Time frame: Baseline, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)
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.
Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1
Time frame: Baseline, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
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.
Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2
Time frame: Baseline, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
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.
Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1
Time frame: Baseline, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to 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.
Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2
Time frame: Baseline, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
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.
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
Time frame: Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9)
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.
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
Time frame: Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)
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.
Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1
Time frame: Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
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.
Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2
Time frame: Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
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.
Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1
Time frame: Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
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.
Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2
Time frame: Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
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.

28 secondary outcomes

Number of Participants With Rebound Anxiety for Cohort 1 (Less Than 3-Month Last Visit)
Time frame: 2 weeks post-treatment discontinuation (discontinuation occurred prior to Week 9)
Number of Participants With Rebound Anxiety for Cohort 2 (3-Month Last Visit)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)
Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit)
Time frame: 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)
Time frame: Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24)
Hamilton Anxiety Scale (HAM-A) Score for Period 1
Time frame: Baseline, Week 12
Hamilton Anxiety Scale (HAM-A) Score for Period 2
Time frame: Baseline, Week 24
Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 24
Time frame: Baseline, Week 24
Clinical Global Impression - Severity (CGI-S) Score for Period 1
Time frame: Baseline, Week 12
Clinical Global Impression - Severity (CGI-S) Score for Period 2
Time frame: Baseline, Week 24
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 24
Time frame: Baseline, Week 24
Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 1
Time frame: Week 12
Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 2
Time frame: Week 24

Results and safety

Results posted to the registry on 19 Apr 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pregabalin High Dose, Pregabalin High Dose	154	121
Pregabalin High Dose, Placebo	52	39
Pregabalin Low Dose, Pregabalin Low Dose	154	112
Pregabalin Low Dose, Placebo	52	38
Lorazepam, Lorazepam	153	114
Lorazepam, Placebo	50	39

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

Time frame: Baseline, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9). Mean (Standard Deviation). Unit: units on a scale

Measure	Pregabalin High Dose n = 15	Pregabalin Low Dose n = 19	Lorazepam n = 21
Baseline (n=15,19,21)	25.8 (4.23)	24.9 (4.15)	24.4 (4.88)
Change at Discontinuation Week 1 (n=15,19,18)	-7.7 (6.75)	-5.9 (7.20)	-9.9 (10.81)

Population analysed: Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included. n=participants evaluable at given time points for each group.

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

Time frame: Baseline, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9). Mean (Standard Deviation). Unit: units on a scale

Measure	Pregabalin High Dose n = 14	Pregabalin Low Dose n = 15	Lorazepam n = 16
Value	-12.0 (7.24)	-5.9 (5.46)	-9.7 (11.08)

Population analysed: Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

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

Time frame: Baseline, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15). Mean (Standard Deviation). Unit: units on a scale

Measure	Pregabalin High Dose n = 58	Pregabalin Low Dose n = 52	Lorazepam n = 52
Baseline	25.0 (5.37)	24.7 (3.89)	24.6 (4.76)
Change at Discontinuation Week 1	-15.3 (7.76)	-15.3 (6.71)	-15.8 (7.92)

Population analysed: Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis.

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

Time frame: Baseline, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15). Mean (Standard Deviation). Unit: units on a scale

Measure	Pregabalin High Dose n = 54	Pregabalin Low Dose n = 49	Lorazepam n = 44
Value	-15.6 (7.42)	-14.9 (7.11)	-16.0 (7.96)

Population analysed: Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.

28 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pregabalin High Dose, Pregabalin High Dose	2 of 154 (1.3%)	110 of 154 (71.4%)	Not reported
Pregabalin High Dose, Placebo	0 of 52 (0%)	40 of 52 (76.9%)	Not reported
Pregabalin Low Dose, Pregabalin Low Dose	5 of 154 (3.2%)	108 of 154 (70.1%)	Not reported
Pregabalin Low Dose, Placebo	2 of 52 (3.8%)	38 of 52 (73.1%)	Not reported
Lorazepam, Lorazepam	4 of 153 (2.6%)	100 of 153 (65.4%)	Not reported
Lorazepam, Placebo	0 of 50 (0%)	35 of 50 (70%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24351233Kasper 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

57 sites in 16 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pregabalin and Lorazepam in people with Generalized Anxiety Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 57 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in Czechia, Finland, Russia, Argentina, India and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 (time frame: Baseline, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00624780, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.