Generalized Anxiety DisorderPhase 3NCT00413010

Pregabalin in the Treatment of Patients With Generalized Anxiety Disorder (GAD).

A Phase 3 study testing pregabalin in people with Generalized Anxiety Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 68 sites in 8 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 primary objective of this study is to evaluate the efficacy of pregabalin as compared to placebo in the treatment of patients with general anxiety disorder (GAD). Efficacy will be measured by the improvement in the total Hamilton Anxiety Rating Scale (HAM-A) scores from baseline observed following 8 weeks of… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Generalized Anxiety Disorder
What is being tested?: pregabalin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 356 participants
Where: 68 sitesin 8 countries
Study dates: Dec 2006to Mar 2008
Phase: Phase 3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult male and female subjects with primary DSM-IV diagnosis of GAD, as confirmed by the MINI structured interview.
Historical failure to respond optimally to a GAD treatment

Who cannot join

Current primary DSM-IV (Diagnostic and Statistical Manual of Mental Disorders 4th edition) diagnosis of major depressive disorder with or without seasonal pattern, dysthmic disorder, depressive disorder NOS (not otherwise specified), social phobia, panic disorder with or without agoraphobia, post traumatic stress disorder, dissociative disorder, borderline personality disorder, obsessive-compulsive disorder, antisocial personality disorder, as defined in the DSM-IV TR (Diagnostic and Statistical Manual of Mental Disorders 4th edition, Text Revision).
Past and/or current DSM-IV diagnosis of schizophrenia, schizoaffective disorder, other psychotic disorders, bipolar disorders (I or II), factitious disorder or cognitive disorder (including delirium, dementia, and amnestic disorder).

Trial locations and contacts

68 sites in 8 countries.

Country

City, postcode or hospital

68 sites in 8 countries

United States35 sites

Pfizer Investigational Site
Albuquerque, New Mexico, 87102
Pfizer Investigational Site
Arcadia, California, 91007-3462
Pfizer Investigational Site
Bala-Cynwyd, Pennsylvania, 19004
Pfizer Investigational Site
Baltimore, Maryland, 21208
Pfizer Investigational Site
Beachwood, Ohio, 44122
Pfizer Investigational Site
Boston, Massachusetts, 02114
Pfizer Investigational Site
Burbank, California, 91506
Pfizer Investigational Site
Cincinnati, Ohio, 45227
Pfizer Investigational Site
Clementon, New Jersey, 08021
Pfizer Investigational Site
Cleveland, Ohio, 44109-1998
Pfizer Investigational Site
Columbia, South Carolina, 29201
Pfizer Investigational Site
Destin, Florida, 32541
Pfizer Investigational Site
Fort Walton Beach, Florida, 32547
Pfizer Investigational Site
Houston, Texas, 77008
Pfizer Investigational Site
Houston, Texas, 77074
Pfizer Investigational Site
Lake Jackson, Texas, 77566
Pfizer Investigational Site
Media, Pennsylvania, 19063
Pfizer Investigational Site
Memphis, Tennessee, 38117
Pfizer Investigational Site
Memphis, Tennessee, 38133
Pfizer Investigational Site
Miami, Florida, 33143
Pfizer Investigational Site
New York, New York, 10128-1708
Pfizer Investigational Site
Norwich, Connecticut, 06360
Pfizer Investigational Site
Olive Branch, Mississippi, 38654
Pfizer Investigational Site
Omaha, Nebraska, 68131
Pfizer Investigational Site
Overland Park, Kansas, 66212
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19104-3309
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19136
Pfizer Investigational Site
Redlands, California, 92374
Pfizer Investigational Site
Saint Charles, Missouri, 63301
Pfizer Investigational Site
Sherman Oaks, California, 91403
Pfizer Investigational Site
Shreveport, Louisiana, 71101
Pfizer Investigational Site
Shreveport, Louisiana, 71104
Pfizer Investigational Site
South Miami, Florida, 33143
Pfizer Investigational Site
Waukesha, Wisconsin, 53188-1660
Pfizer Investigational Site
Wichita, Kansas, 67207

Other trials in United States

Russia8 sites

Pfizer Investigational Site
Moscow, 115522
Pfizer Investigational Site
Moscow, 119034
Pfizer Investigational Site
Moscow, 123367
Pfizer Investigational Site
Saint Petersburg, 190121
Pfizer Investigational Site
Saint Petersburg, 191180
Pfizer Investigational Site
Saint Petersburg, 192019
Pfizer Investigational Site
Smolensk, 214018
Pfizer Investigational Site
Smolensk, 214019

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Czechia6 sites

Pfizer Investigational Site
Brno, 602 00
Pfizer Investigational Site
Litoměřice, 412 01
Pfizer Investigational Site
Prague, 120 00
Pfizer Investigational Site
Prague, 158 00
Pfizer Investigational Site
Prague, 163 00
Pfizer Investigational Site
Praha 8 - Bohnice, 181 03

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Ukraine6 sites

Pfizer Investigational Site
Dnipropetrovsk, 49005
Pfizer Investigational Site
Dnipropetrovsk, 49115
Pfizer Investigational Site
Donetsk, 83037
Pfizer Investigational Site
Kyiv, 01030
Pfizer Investigational Site
Luhansk, 91045
Pfizer Investigational Site
Lviv, 79021

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Serbia4 sites

Pfizer Investigational Site
Belgrade, 11 000
Pfizer Investigational Site
Belgrade, 11000
Pfizer Investigational Site
Belgrade
Pfizer Investigational Site
Kragujevac, 34000

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Estonia3 sites

Pfizer Investigational Site
Tallinn, 10614
Pfizer Investigational Site
Tartu, 50417
Pfizer Investigational Site
Viljandi, Viljandi Mk., 71024

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Finland3 sites

Pfizer Investigational Site
Helsinki, 00029 HUS
Pfizer Investigational Site
Joensuu, 80100
Pfizer Investigational Site
Kuopio, 70110

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Hungary3 sites

Pfizer Investigational Site
Budapest, 1083
Pfizer Investigational Site
Budapest, 1137
Pfizer Investigational Site
Pécs, 7623

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About this study

Official title: An 8-Week, Double-Blind, Placebo-Controlled, Phase 3 Trial of Pregabalin (150-600 mg/Day) in the Adjunctive Treatment of Patients With Generalized Anxiety Disorder (GAD) Who Have Not Optimally Responded to Existing Therapies(GAD)

Read the detailed description

Further enrollment in this study was stopped on January 28, 2008 based on the recommendation of an independent data monitoring committee. The recommendation to stop the study was not based on any safety findings.

Conditions: Generalized Anxiety Disorder
Being tested: pregabalin, 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 150-600 mg/day flexibly dosed for the first 6 weeks and fixed dosed for the last 2 weeks of total 8 weeks of double blind study period, + concurrent GAD treatment from the open-label study period
placeboDrug
placebo + concurrent GAD treatment from the open-label study period

Study groups in NCT00413010
Study group	Role	What they receive
Arm 2	Placebo comparator	Not described Receives: Drug: placebo
Arm 1	Experimental	Not described Receives: Drug: pregabalin

What is being measured

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

Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores
Change from baseline: average across visit weeks using mixed model. HAM-A=clinician-rated interview measuring presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, \& restlessness. Total score ranges from 0 to 56; higher score indicates greater anxiety.
Measured: Baseline, 8 weeks

Secondary outcomes (7)

Change in HAM-A Total Score at Weekly Visits
Change: score at each study week minus score at baseline. HAM-A, a clinician-rated interview, measures presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, \& restlessness. Total score ranges from 0 to 56; higher score indicates greater anxiety.
Measured: Baseline, Weeks 1 through Week 8
Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A)
Responders = YES if subjects achieved a >= 50% decrease in HAM-A total score from Baseline to respective study week. HAM-A is a clinician-rated interview measuring the presence of anxiety-related symptoms in 14 areas. Total score ranges from 0 to 56; higher score indicates greater anxiety.
Measured: Weeks 1 through Week 8
Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score
Participant in remission defined as HAM-A total score of <= 7. HAM-A=clinician-rated interview measuring presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, \& restlessness. Total score ranges 0 - 56; higher score indicates greater anxiety.
Measured: Week 1 through Week 8
Time to Onset of Sustained Hamilton Anxiety Rating Scale (HAM-A) Improvement
Time to sustained improvement was defined as time to 50% or greater reduction in HAM-A total score from Baseline, which was sustained for the remainder of the study. HAM-A is a clinician-rated interview measuring the presence of anxiety-related symptoms in 14 areas. Total score ranges from 0 to 56; a higher score indicates greater anxiety.
Measured: Week 8
Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score
Responders = YES using CGI-I if score indicated much improved or very much improved at the last study week. CGI-I is a clinician-rated instrument that measures change in subject's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Measured: Week 1 through Week 8
Clinical Global Impression of Severity (CGI-S) Score
CGI-S is a clinician-rated instrument measuring the severity of a subject's symptoms on a 7-point categorical scale. Scores range from 1 (not at all ill) to 7 (among the most extremely ill patients). Higher score indicates that the subject is more ill.
Measured: Week 8
Change in Hamilton Depression Rating Scale (HAM-D) Total Score
Change: score at each study week minus score at baseline. HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, \& weight loss). Total score ranges from 0 to 52; higher scores indicate more depression.
Measured: Weeks 1 through Week 8

Timeline

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

Dec 2006Mar 2008

First posted19 Dec 2006 (estimated)
Study startDec 2006
Primary completionFeb 2008
Study completionMar 2008

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 356 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00413010
Sponsor's protocol ID: A0081103
Status last verified: Dec 2009
First submitted: 15 Dec 2006
Last updated: 10 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Rickels K, Shiovitz TM, Ramey TS, Weaver JJ, Knapp LE, Miceli JJ. Adjunctive therapy with pregabalin in generalized anxiety disorder patients with partial response to SSRI or SNRI treatment. Int Clin Psychopharmacol. 2012 May;27(3):142-50. doi: 10.1097/YIC.0b013e328350b133.
PubMed 22302014

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An 8-Week, Double-Blind, Placebo-Controlled, Phase 3 Trial of Pregabalin (150-600 mg/Day) in the Adjunctive Treatment of Patients With Generalized Anxiety Disorder (GAD) Who Have Not Optimally Responded to Existing Therapies(GAD)
ClinicalTrials.gov ID: NCT00413010
Acronym / sponsor ID: A0081103
Conditions: Generalized Anxiety Disorder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 356 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Dec 2006
Primary completion: Feb 2008 (actual)
Study completion: Mar 2008 (actual)
First posted: 19 Dec 2006 (estimated)
Results: Posted 2 Dec 2009

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Arm 2	Placebo comparator	Drug: placebo
Arm 1	Experimental	Drug: pregabalin

Who may qualify

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

Key inclusion criteria (2 listed)

Adult male and female subjects with primary DSM-IV diagnosis of GAD, as confirmed by the MINI structured interview.
Historical failure to respond optimally to a GAD treatment

Key exclusion criteria (2 listed)

Current primary DSM-IV (Diagnostic and Statistical Manual of Mental Disorders 4th edition) diagnosis of major depressive disorder with or without seasonal pattern, dysthmic disorder, depressive disorder NOS (not otherwise specified), social phobia, panic disorder with or without agoraphobia, post traumatic stress disorder, dissociative disorder, borderline personality disorder, obsessive-compulsive disorder, antisocial personality disorder, as defined in the DSM-IV TR (Diagnostic and Statistical Manual of Mental Disorders 4th edition, Text Revision).
Past and/or current DSM-IV diagnosis of schizophrenia, schizoaffective disorder, other psychotic disorders, bipolar disorders (I or II), factitious disorder or cognitive disorder (including delirium, dementia, and amnestic 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 150-600 mg/day flexibly dosed for the first 6 weeks and fixed dosed for the last 2 weeks of total 8 weeks of double blind study period, + concurrent GAD treatment from the open-label study period	Drug	Arm 1
placeboplacebo + concurrent GAD treatment from the open-label study period	Drug	Arm 2

Primary outcome

Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores
Time frame: Baseline, 8 weeks
Change from baseline: average across visit weeks using mixed model. HAM-A=clinician-rated interview measuring presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, \& restlessness. Total score ranges from 0 to 56; higher score indicates greater anxiety.

7 secondary outcomes

Change in HAM-A Total Score at Weekly Visits
Time frame: Baseline, Weeks 1 through Week 8
Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A)
Time frame: Weeks 1 through Week 8
Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score
Time frame: Week 1 through Week 8
Time to Onset of Sustained Hamilton Anxiety Rating Scale (HAM-A) Improvement
Time frame: Week 8
Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score
Time frame: Week 1 through Week 8
Clinical Global Impression of Severity (CGI-S) Score
Time frame: Week 8
Change in Hamilton Depression Rating Scale (HAM-D) Total Score
Time frame: Weeks 1 through Week 8

Results and safety

Results posted to the registry on 2 Dec 2009, 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	180	108
Placebo	176	113

Primary outcome: Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores

Time frame: Baseline, 8 weeks. Least squares mean (Standard Error). Unit: score on scale

Measure	Pregabalin n = 177	Placebo n = 176
Value	-7.6 (0.35)	-6.4 (0.36)

Pregabalin vs Placebo: Mean Difference (Final Values): -1.2 (95% CI -2.16 to -0.26), Mixed Models Analysis

Population analysed: Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment. All efficacy analyses included the ITT subjects who had a Baseline and a post-Baseline assessment of the respective efficacy endpoints.

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pregabalin	1 of ?	81 of ?	Not reported
Placebo	3 of ?	59 of ?	Not reported

Limitations and caveats (from the sponsor): Further enrollment in this study was stopped based on the recommendation of an independent Data Monitoring Committee (DMC). An interim data analysis did not suggest the potential for robust efficacy. The study was not stopped for any safety findings.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22302014Rickels K, Shiovitz TM, Ramey TS, Weaver JJ, Knapp LE, Miceli JJ. Adjunctive therapy with pregabalin in generalized anxiety disorder patients with partial response to SSRI or SNRI treatment. Int Clin Psychopharmacol. 2012 May;27(3):142-50. doi: 10.1097/YIC.0b013e328350b133.

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RecruitingObservational study
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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

68 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pregabalin in people with Generalized Anxiety Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 68 sites in 8 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 2 inclusion and 2 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 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, Russia, Czechia, Ukraine, Serbia and 3 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 2 Dec 2009). 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 in Hamilton Anxiety Rating Scale (HAM-A) Total Scores (time frame: Baseline, 8 weeks). 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 NCT00413010, 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 10 Feb 2021.