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

NCT00413010 | Completed Phase 3 Results DMC

• 1 other identifier: A0081103
• Study Type: interventional
• Target: 356
• Locations: 8 countries
• Sites: 68

Brief 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 double-blind treatment or at earlier termination during the double-blind treatment phase and analyzed using a mixed linear model for repeated measures.

Conditions

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 8 weeks

Secondary Outcomes (7)

• Change in HAM-A Total Score at Weekly Visits

  Baseline, Weeks 1 through Week 8

• Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A)

  Weeks 1 through Week 8

• Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score

  Week 1 through Week 8

• Time to Onset of Sustained Hamilton Anxiety Rating Scale (HAM-A) Improvement

  Week 8

• Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score

  Week 1 through Week 8

Study Arms (2)

Arm 2

PLACEBO COMPARATOR

Drug: placebo

Arm 1

EXPERIMENTAL

Drug: pregabalin

Interventions

pregabalin DRUG

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

Also known as: Lyrica

Arm 1

placebo DRUG

placebo + concurrent GAD treatment from the open-label study period

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (68)

Pfizer Investigational Site

Arcadia, California, 91007-3462, United States

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Burbank, California, 91506, United States

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Redlands, California, 92374, United States

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Sherman Oaks, California, 91403, United States

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Norwich, Connecticut, 06360, United States

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Destin, Florida, 32541, United States

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Fort Walton Beach, Florida, 32547, United States

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Miami, Florida, 33143, United States

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South Miami, Florida, 33143, United States

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Overland Park, Kansas, 66212, United States

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Wichita, Kansas, 67207, United States

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Shreveport, Louisiana, 71101, United States

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Shreveport, Louisiana, 71104, United States

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Baltimore, Maryland, 21208, United States

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Boston, Massachusetts, 02114, United States

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Olive Branch, Mississippi, 38654, United States

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Saint Charles, Missouri, 63301, United States

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Omaha, Nebraska, 68131, United States

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Clementon, New Jersey, 08021, United States

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Albuquerque, New Mexico, 87102, United States

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New York, New York, 10128-1708, United States

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Beachwood, Ohio, 44122, United States

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Cincinnati, Ohio, 45227, United States

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Cleveland, Ohio, 44109-1998, United States

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Bala-Cynwyd, Pennsylvania, 19004, United States

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Media, Pennsylvania, 19063, United States

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Philadelphia, Pennsylvania, 19104-3309, United States

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Philadelphia, Pennsylvania, 19136, United States

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Columbia, South Carolina, 29201, United States

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Memphis, Tennessee, 38117, United States

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Memphis, Tennessee, 38133, United States

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Houston, Texas, 77008, United States

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Houston, Texas, 77074, United States

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Lake Jackson, Texas, 77566, United States

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Waukesha, Wisconsin, 53188-1660, United States

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Brno, 602 00, Czechia

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Litoměřice, 412 01, Czechia

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Prague, 120 00, Czechia

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Prague, 158 00, Czechia

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Prague, 163 00, Czechia

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Praha 8 - Bohnice, 181 03, Czechia

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Viljandi, Viljandi Mk., 71024, Estonia

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Tallinn, 10614, Estonia

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Tartu, 50417, Estonia

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Helsinki, 00029 HUS, Finland

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Joensuu, 80100, Finland

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Kuopio, 70110, Finland

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Budapest, 1083, Hungary

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Budapest, 1137, Hungary

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Pécs, 7623, Hungary

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Moscow, 115522, Russia

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Moscow, 119034, Russia

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Moscow, 123367, Russia

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Saint Petersburg, 190121, Russia

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Saint Petersburg, 191180, Russia

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Saint Petersburg, 192019, Russia

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Smolensk, 214018, Russia

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Smolensk, 214019, Russia

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Belgrade, 11 000, Serbia

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Belgrade, 11000, Serbia

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Belgrade, Serbia

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Kragujevac, 34000, Serbia

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Dnipropetrovsk, 49005, Ukraine

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Dnipropetrovsk, 49115, Ukraine

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Donetsk, 83037, Ukraine

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Kyiv, 01030, Ukraine

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Luhansk, 91045, Ukraine

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Lviv, 79021, Ukraine

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Related Publications (1)

• 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.

  PMID: 22302014 DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

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.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2006
• First Posted: December 19, 2006
• Study Start: December 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: March 1, 2008
• Last Updated: February 10, 2021
• Results First Posted: December 2, 2009

Record last verified: 2009-12

Locations

RU (8); SE (4); HU (3); ES (3); FI (3); US (35); CZ (6); UA (6)