You are here

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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Arcadia, California, 91007-3462 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Generalized Anxiety Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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).

NCT00413010
Pfizer
Completed
Pregabalin in the Treatment of Patients With Generalized Anxiety Disorder (GAD).

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Estonia,   Finland,   Hungary,   Russian Federation,   Serbia,   Ukraine,   United States
Former Serbia and Montenegro,   Romania
 
NCT00413010
A0081103
Yes
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now