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


Tracking Information

Start Date  ICMJEApril 2009
Estimated Primary Completion DateJune 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: February 15, 2008)
  • Safety endpoints: Adverse events at 3 and 6 months, Physicians Withdrawal Checklist (PWC), Rebound Anxiety (HAM-A), Discontinuation Emergent Signs and Symptoms (DESS) [ Time Frame: 3 and 6 months ] [ Designated as safety issue: Yes ]
  • Efficacy endpoints: Hamilton Anxiety Scale (HAM-A), Clinical Global Impression-Severity (CGI-S), Clinical Global Impression-Improvement (CGI-I). [ Time Frame: 3 and 6 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00624780 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: February 15, 2008)		Adverse events [ Time Frame: through study ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJESafety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder
Official Title  ICMJELong 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 
Study PhasePhase IV
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEGeneralized 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 / Comparison Groups
  • 1: Experimental
    Intervention: Drug: Pregabalin
  • 2: Active Comparator
    Intervention: Drug: Lorazepam
  • 3: Experimental
    Intervention: Drug: Pregabalin
  • 4: Placebo Comparator
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE600
Estimated Completion DateJune 2011
Estimated Primary Completion DateJune 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Diagnosis of GAD. 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.

GenderBoth
Ages18 Years to 65 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021
Location Countries  ICMJEArgentina,   Austria,   Costa Rica,   Czech Republic,   Finland,   Greece,   India,   Indonesia,   Lithuania,   Russian Federation,   Serbia,   Slovenia,   Spain,   Turkey

Administrative Information

NCT ID  ICMJENCT00624780
Responsible PartyDirector, Clinical Trials Disclosure Group, Pfizer, Inc.
Study ID Numbers  ICMJEA0081147
Study Sponsor  ICMJEPfizer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Information Provided ByPfizer