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
Results First Received: February 27, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Generalized Anxiety Disorder
Interventions: Drug: pregabalin
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted in 55 centers in 8 countries (United States, Russian Federation, Czech Republic, Ukraine, Serbia, Hungary, Finland, and Estonia).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After a screening phase (Period 1), subjects entered an 8-week open-label treatment optimzation phase (Period 2). Only those subjects who partially responded to background Generalized Anxiety Disorder (GAD) treatment (escitalopram, paroxetine, or venlafaxine XR) and met all inclusion/exclusion criteria were eligible for randomization (Period 3).

Reporting Groups
  Description
Pregabalin Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
Placebo Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).

Participant Flow:   Overall Study
    Pregabalin     Placebo  
STARTED     180     176  
COMPLETED     108     113  
NOT COMPLETED     72     63  
Adverse Event                 8                 4  
Laboratory abnormality                 0                 2  
Lack of Efficacy                 0                 3  
Lost to Follow-up                 3                 0  
Withdrawal by Subject                 7                 2  
Due to termination of the study                 54                 52  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pregabalin Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
Placebo Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
Total Total of all reporting groups

Baseline Measures
    Pregabalin     Placebo     Total  
Number of Participants  
[units: participants]
  180     176     356  
Age  
[units: years]
Mean ± Standard Deviation
  43.7  ± 11.5     43.5  ± 12.5     43.6  ± 12.0  
Gender  
[units: participants]
     
Female     129     115     244  
Male     51     61     112  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores   [ Time Frame: Baseline, 8 weeks ]

2.  Secondary:   Change in HAM-A Total Score at Weekly Visits   [ Time Frame: Baseline, Weeks 1 through Week 8 ]

3.  Secondary:   Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A)   [ Time Frame: Weeks 1 through Week 8 ]

4.  Secondary:   Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score   [ Time Frame: Week 1 through Week 8 ]

5.  Secondary:   Time to Onset of Sustained Hamilton Anxiety Rating Scale (HAM-A) Improvement   [ Time Frame: Week 8 ]

6.  Secondary:   Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score   [ Time Frame: Week 1 through Week 8 ]

7.  Secondary:   Clinical Global Impression of Severity (CGI-S) Score   [ Time Frame: Week 8 ]

8.  Secondary:   Change in Hamilton Depression Rating Scale (HAM-D) Total Score   [ Time Frame: Weeks 1 through Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Further enrollment in this study was stopped based on the recommendation of an independent Data Monitoring Committee (DMC). An interim data analysis did not suggest the potential for robust efficacy. The study was not stopped for any safety findings.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com


No publications provided by Pfizer

Publications automatically indexed to this study:

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00413010     History of Changes
Other Study ID Numbers: A0081103
Study First Received: December 15, 2006
Results First Received: February 27, 2009
Last Updated: December 3, 2009
Health Authority: United States: Food and Drug Administration