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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00413010
First received: December 15, 2006
Last updated: December 3, 2009
Last verified: December 2009

December 15, 2006
December 3, 2009
December 2006
February 2008   (final data collection date for primary outcome measure)
Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  • 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.
Complete list of historical versions of study NCT00413010 on ClinicalTrials.gov Archive Site
  • Change in HAM-A Total Score at Weekly Visits [ Time Frame: Baseline, Weeks 1 through Week 8 ] [ Designated as safety issue: No ]
  • Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: Weeks 1 through Week 8 ] [ Designated as safety issue: No ]
  • Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score [ Time Frame: Week 1 through Week 8 ] [ Designated as safety issue: No ]
  • Time to Onset of Sustained Hamilton Anxiety Rating Scale (HAM-A) Improvement [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score [ Time Frame: Week 1 through Week 8 ] [ Designated as safety issue: No ]
  • Clinical Global Impression of Severity (CGI-S) Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Change in Hamilton Depression Rating Scale (HAM-D) Total Score [ Time Frame: Weeks 1 through Week 8 ] [ Designated as safety issue: No ]
  • 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.
Not Provided
Not Provided
 
Pregabalin in the Treatment of Patients With Generalized Anxiety Disorder (GAD).
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)

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Generalized Anxiety Disorder
  • 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
  • Placebo Comparator: Arm 2
    Intervention: Drug: placebo
  • Experimental: Arm 1
    Intervention: Drug: pregabalin
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.
 
Completed
356
March 2008
February 2008   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Czech Republic,   Estonia,   Finland,   Hungary,   Russian Federation,   Serbia,   Ukraine
 
NCT00413010
A0081103
Yes
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2009

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