Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder

NCT00624780

Last updated date
Study Location
Pfizer Investigational Site
La Plata, Buenos Aires, B1904ADM, Argentina
Contact
1-800-718-1021

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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
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis Generalized Anxiety Disorder

- HAM-A score >=18 and HAM-D (item 1) score >=2 at screening and baseline

- Needs pharmacological treatment

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


- Current or past diagnosis of any other DSM IV Axis I disorders


- A history of failed treatment with a benzodiazepine


- Any clinically significant, serious, or unstable hematologic, autoimmune, endocrine,
cardiovascular, renal, hepatic, gastrointestinal, or neurological disorder

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Advanced Information
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder
Official Title  ICMJE Long Term Safety And Efficacy Study Of Pregabalin (Lyrica) In Subjects With Generalized Anxiety Disorder
Brief Summary The purpose of this study is to characterize the safety and efficacy in patients with generalized anxiety disorder after short- (3 months) and long-term (6 months) use of Pregabalin (Lyrica).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
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 150-300 mg given twice a day
    Other Name: Lyrica
  • Drug: Lorazepam
    Lorazepam 3-4 mg given twice a day
  • Drug: Pregabalin
    Pregabalin 450-600 mg given twice a day
    Other Name: Lyrica
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Pregabalin
  • Active Comparator: 2
    Intervention: Drug: Lorazepam
  • Experimental: 3
    Intervention: Drug: Pregabalin
  • Placebo Comparator: 4
    Intervention: Drug: Placebo
Publications * Kasper S, Iglesias-García C, Schweizer E, Wilson J, DuBrava S, Prieto R, Pitman VW, Knapp L. Pregabalin long-term treatment and assessment of discontinuation in patients with generalized anxiety disorder. Int J Neuropsychopharmacol. 2014 May;17(5):685-95. doi: 10.1017/S1461145713001557. Epub 2013 Dec 19.

*   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: September 25, 2012)
615
Original Estimated Enrollment  ICMJE
 (submitted: February 15, 2008)
600
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis Generalized Anxiety Disorder
  • HAM-A score >=18 and HAM-D (item 1) score >=2 at screening and baseline
  • Needs pharmacological treatment

Exclusion Criteria:

  • Current or past diagnosis of any other DSM IV Axis I disorders
  • A history of failed treatment with a benzodiazepine
  • Any clinically significant, serious, or unstable hematologic, autoimmune, endocrine, cardiovascular, renal, hepatic, gastrointestinal, or neurological disorder
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (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 Argentina,   Austria,   Costa Rica,   Croatia,   Czech Republic,   Finland,   Greece,   India,   Indonesia,   Lithuania,   Mexico,   Russian Federation,   Serbia,   Slovenia,   Spain,   Turkey
Removed Location Countries Colombia
 
Administrative Information
NCT Number  ICMJE NCT00624780
Other Study ID Numbers  ICMJE A0081147
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2012

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