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

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ClinicalTrials.gov Identifier: NCT00413010
Recruitment Status : Completed
First Posted : December 19, 2006
Results First Posted : December 2, 2009
Last Update Posted : December 9, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE December 15, 2006
First Posted Date  ICMJE December 19, 2006
Results First Submitted Date  ICMJE February 27, 2009
Results First Posted Date  ICMJE December 2, 2009
Last Update Posted Date December 9, 2009
Study Start Date  ICMJE December 2006
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2009)
Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores [ Time Frame: Baseline, 8 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 18, 2006)
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2006)
  • HAM-A changes from baseline by week
  • HAM-A responders (greater than/equal to 50% decrease in total HAM-A scores from baseline through Week 8)
  • Time to onset of sustained HAM-A improvement (greater than/equal to 50% reduction in HAM-A score from baseline)
  • HAM-A Psychic Anxiety and Somatic subscale changes
  • Remission rate (HAM-A less than/equal to 7) in subjects at last study week
  • Hamilton Depression Rating Scale score change from baseline through week 8
  • Sheehan Disability Scale (SDS) total and domain scale change from baseline
  • Changes in the Daily Diary and Daily Assessment of Symptoms-Anxiety (DAS-A) and Global Anxiety-Visual Analogue Scale (GA-VAS) component and total scores from baseline
  • CGI-S at the subject's last study week
  • CGI-I responders (CGI-I greater than/equal to 2, much improved or very much improved) at the subject's last study week.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pregabalin in the Treatment of Patients With Generalized Anxiety Disorder (GAD).
Official Title  ICMJE 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)
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Generalized Anxiety Disorder
Intervention  ICMJE
  • Drug: pregabalin
    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
    Other Name: Lyrica
  • Drug: placebo
    placebo + concurrent GAD treatment from the open-label study period
Study Arms  ICMJE
  • Placebo Comparator: Arm 2
    Intervention: Drug: placebo
  • Experimental: Arm 1
    Intervention: Drug: pregabalin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2009)
356
Original Enrollment  ICMJE
 (submitted: December 18, 2006)
350
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic,   Estonia,   Finland,   Hungary,   Russian Federation,   Serbia,   Ukraine,   United States
Removed Location Countries Former Serbia and Montenegro,   Romania
 
Administrative Information
NCT Number  ICMJE NCT00413010
Other Study ID Numbers  ICMJE A0081103
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP