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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
356
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
placebo + concurrent GAD treatment from the open-label study period
Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores
Change from baseline: average across visit weeks using mixed model. HAM-A=clinician-rated interview measuring presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, \& restlessness. Total score ranges from 0 to 56; higher score indicates greater anxiety.
Time frame: Baseline, 8 weeks
Change in HAM-A Total Score at Weekly Visits
Change: score at each study week minus score at baseline. HAM-A, a clinician-rated interview, measures presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, \& restlessness. Total score ranges from 0 to 56; higher score indicates greater anxiety.
Time frame: Baseline, Weeks 1 through Week 8
Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A)
Responders = YES if subjects achieved a \>= 50% decrease in HAM-A total score from Baseline to respective study week. HAM-A is a clinician-rated interview measuring the presence of anxiety-related symptoms in 14 areas. Total score ranges from 0 to 56; higher score indicates greater anxiety.
Time frame: Weeks 1 through Week 8
Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score
Participant in remission defined as HAM-A total score of \<= 7. HAM-A=clinician-rated interview measuring presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, \& restlessness. Total score ranges 0 - 56; higher score indicates greater anxiety.
Time frame: Week 1 through Week 8
Time to Onset of Sustained Hamilton Anxiety Rating Scale (HAM-A) Improvement
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Time to sustained improvement was defined as time to 50% or greater reduction in HAM-A total score from Baseline, which was sustained for the remainder of the study. HAM-A is a clinician-rated interview measuring the presence of anxiety-related symptoms in 14 areas. Total score ranges from 0 to 56; a higher score indicates greater anxiety.
Time frame: Week 8
Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score
Responders = YES using CGI-I if score indicated much improved or very much improved at the last study week. CGI-I is a clinician-rated instrument that measures change in subject's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Time frame: Week 1 through Week 8
Clinical Global Impression of Severity (CGI-S) Score
CGI-S is a clinician-rated instrument measuring the severity of a subject's symptoms on a 7-point categorical scale. Scores range from 1 (not at all ill) to 7 (among the most extremely ill patients). Higher score indicates that the subject is more ill.
Time frame: Week 8
Change in Hamilton Depression Rating Scale (HAM-D) Total Score
Change: score at each study week minus score at baseline. HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, \& weight loss). Total score ranges from 0 to 52; higher scores indicate more depression.
Time frame: Weeks 1 through Week 8