Trial Outcomes & Findings for Pregabalin in the Treatment of Patients With Generalized Anxiety Disorder (GAD). (NCT NCT00413010)
NCT ID: NCT00413010
Last Updated: 2021-02-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
356 participants
Primary outcome timeframe
Baseline, 8 weeks
Results posted on
2021-02-10
Participant Flow
The study was conducted in 55 centers in 8 countries (United States, Russian Federation, Czech Republic, Ukraine, Serbia, Hungary, Finland, and Estonia).
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).
Participant milestones
| Measure |
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).
|
|---|---|---|
|
Overall Study
STARTED
|
180
|
176
|
|
Overall Study
COMPLETED
|
108
|
113
|
|
Overall Study
NOT COMPLETED
|
72
|
63
|
Reasons for withdrawal
| Measure |
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).
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
4
|
|
Overall Study
Laboratory abnormality
|
0
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
7
|
2
|
|
Overall Study
Due to termination of the study
|
54
|
52
|
Baseline Characteristics
Pregabalin in the Treatment of Patients With Generalized Anxiety Disorder (GAD).
Baseline characteristics by cohort
| Measure |
Pregabalin
n=180 Participants
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
n=176 Participants
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
n=356 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.7 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
43.5 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
43.6 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
129 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
244 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 8 weeksPopulation: Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment. All efficacy analyses included the ITT subjects who had a Baseline and a post-Baseline assessment of the respective efficacy endpoints.
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.
Outcome measures
| Measure |
Pregabalin
n=177 Participants
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
n=176 Participants
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).
|
|---|---|---|
|
Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores
|
-7.6 score on scale
Standard Error 0.35
|
-6.4 score on scale
Standard Error 0.36
|
SECONDARY outcome
Timeframe: Baseline, Weeks 1 through Week 8Population: Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment. All efficacy analyses included the ITT subjects who had a Baseline and a post-Baseline assessment of the respective efficacy endpoints.
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.
Outcome measures
| Measure |
Pregabalin
n=177 Participants
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
n=176 Participants
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).
|
|---|---|---|
|
Change in HAM-A Total Score at Weekly Visits
Week 1 (n=164;n=169)
|
-4.4 score on scale
Standard Error 0.37
|
-3.1 score on scale
Standard Error 0.37
|
|
Change in HAM-A Total Score at Weekly Visits
Week 2 (n=166;n=163)
|
-6.3 score on scale
Standard Error 0.43
|
-5.2 score on scale
Standard Error 0.43
|
|
Change in HAM-A Total Score at Weekly Visits
Week 3 (n=157;n=160)
|
-7.0 score on scale
Standard Error 0.45
|
-5.5 score on scale
Standard Error 0.45
|
|
Change in HAM-A Total Score at Weekly Visits
Week 4 (n=153;n=150)
|
-8.3 score on scale
Standard Error 0.46
|
-7.0 score on scale
Standard Error 0.47
|
|
Change in HAM-A Total Score at Weekly Visits
Week 5 (n=135;n=130)
|
-8.4 score on scale
Standard Error 0.49
|
-7.6 score on scale
Standard Error 0.49
|
|
Change in HAM-A Total Score at Weekly Visits
Week 6 (n=122;n=125)
|
-9.2 score on scale
Standard Error 0.49
|
-8.0 score on scale
Standard Error 0.49
|
|
Change in HAM-A Total Score at Weekly Visits
Week 8 (n=126;n=127)
|
-9.3 score on scale
Standard Error 0.56
|
-8.0 score on scale
Standard Error 0.56
|
SECONDARY outcome
Timeframe: Weeks 1 through Week 8Population: Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment, and had a baseline and post-baseline efficacy assessment.
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.
Outcome measures
| Measure |
Pregabalin
n=177 Participants
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
n=176 Participants
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).
|
|---|---|---|
|
Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A)
Week 1 Responder: Yes
|
21 participants
|
8 participants
|
|
Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A)
Week 1 Responder: No
|
143 participants
|
161 participants
|
|
Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A)
Week 2 Responder: Yes
|
39 participants
|
26 participants
|
|
Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A)
Week 2 Responder: No
|
127 participants
|
137 participants
|
|
Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A)
Week 3 Responder: Yes
|
51 participants
|
23 participants
|
|
Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A)
Week 3 Responder: No
|
106 participants
|
137 participants
|
|
Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A)
Week 4 Responder: Yes
|
64 participants
|
46 participants
|
|
Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A)
Week 4 Responder: No
|
89 participants
|
104 participants
|
|
Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A)
Week 5 Responder: Yes
|
58 participants
|
46 participants
|
|
Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A)
Week 5 Responder: No
|
77 participants
|
84 participants
|
|
Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A)
Week 6 Responder: Yes
|
57 participants
|
48 participants
|
|
Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A)
Week 6 Responder: No
|
65 participants
|
77 participants
|
|
Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A)
Week 8 Responder: Yes
|
63 participants
|
47 participants
|
|
Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A)
Week 8 Responder: No
|
63 participants
|
80 participants
|
|
Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A)
Week 8 (LOCF) Responder: Yes
|
84 participants
|
62 participants
|
|
Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A)
Week 8 (LOCF) Responder: No
|
93 participants
|
114 participants
|
SECONDARY outcome
Timeframe: Week 1 through Week 8Population: Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment, and had a baseline and post-baseline efficacy assessment.
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.
Outcome measures
| Measure |
Pregabalin
n=177 Participants
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
n=176 Participants
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).
|
|---|---|---|
|
Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score
Week 1 Remission: Yes
|
12 participants
|
5 participants
|
|
Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score
Week 1 Remission: No
|
152 participants
|
164 participants
|
|
Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score
Week 2 Remission: Yes
|
22 participants
|
15 participants
|
|
Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score
Week 2 Remission: No
|
144 participants
|
148 participants
|
|
Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score
Week 3 Remission: Yes
|
32 participants
|
18 participants
|
|
Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score
Week 3 Remission: No
|
125 participants
|
142 participants
|
|
Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score
Week 4 Remission: Yes
|
43 participants
|
29 participants
|
|
Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score
Week 4 Remission: No
|
110 participants
|
121 participants
|
|
Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score
Week 5 Remission: Yes
|
39 participants
|
30 participants
|
|
Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score
Week 5 Remission: No
|
96 participants
|
100 participants
|
|
Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score
Week 6 Remission: Yes
|
37 participants
|
32 participants
|
|
Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score
Week 6 Remission: No
|
85 participants
|
93 participants
|
|
Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score
Week 8 Remission: Yes
|
40 participants
|
31 participants
|
|
Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score
Week 8 Remission: No
|
86 participants
|
96 participants
|
|
Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score
Week 8 (LOCF) Remission: Yes
|
55 participants
|
42 participants
|
|
Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score
Week 8 (LOCF) Remission: No
|
122 participants
|
134 participants
|
SECONDARY outcome
Timeframe: Week 8Population: Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment, and had a baseline and post-baseline efficacy assessment. CI for placebo patients was not estimable.
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.
Outcome measures
| Measure |
Pregabalin
n=177 Participants
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).
|
|---|---|---|
|
Time to Onset of Sustained Hamilton Anxiety Rating Scale (HAM-A) Improvement
|
57 days
Interval 43.0 to 61.0
|
—
|
SECONDARY outcome
Timeframe: Week 1 through Week 8Population: Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment, and had a baseline and post-baseline efficacy assessment.
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).
Outcome measures
| Measure |
Pregabalin
n=177 Participants
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
n=176 Participants
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).
|
|---|---|---|
|
Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score
Week 1: Yes
|
62 participants
|
49 participants
|
|
Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score
Week 1: No
|
101 participants
|
120 participants
|
|
Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score
Week 2: Yes
|
94 participants
|
74 participants
|
|
Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score
Week 2: No
|
72 participants
|
89 participants
|
|
Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score
Week 3: Yes
|
93 participants
|
76 participants
|
|
Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score
Week 3: No
|
62 participants
|
86 participants
|
|
Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score
Week 4: Yes
|
97 participants
|
88 participants
|
|
Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score
Week 4: No
|
55 participants
|
61 participants
|
|
Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score
Week 5: Yes
|
89 participants
|
81 participants
|
|
Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score
Week 5: No
|
45 participants
|
50 participants
|
|
Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score
Week 6: Yes
|
83 participants
|
76 participants
|
|
Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score
Week 6: No
|
38 participants
|
49 participants
|
|
Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score
Week 8: Yes
|
80 participants
|
82 participants
|
|
Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score
Week 8: No
|
43 participants
|
45 participants
|
|
Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score
Week 8 (LOCF): Yes
|
113 participants
|
110 participants
|
|
Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score
Week 8 (LOCF): No
|
61 participants
|
66 participants
|
SECONDARY outcome
Timeframe: Week 8Population: Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment, and had a baseline and post-baseline efficacy assessment.
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.
Outcome measures
| Measure |
Pregabalin
n=177 Participants
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
n=176 Participants
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).
|
|---|---|---|
|
Clinical Global Impression of Severity (CGI-S) Score
Normal, not ill at all
|
28 participants
|
18 participants
|
|
Clinical Global Impression of Severity (CGI-S) Score
Borderline, mentally ill
|
49 participants
|
37 participants
|
|
Clinical Global Impression of Severity (CGI-S) Score
Mildly ill
|
49 participants
|
63 participants
|
|
Clinical Global Impression of Severity (CGI-S) Score
Moderately ill
|
46 participants
|
48 participants
|
|
Clinical Global Impression of Severity (CGI-S) Score
Markedly ill
|
2 participants
|
8 participants
|
|
Clinical Global Impression of Severity (CGI-S) Score
Severely ill
|
2 participants
|
1 participants
|
|
Clinical Global Impression of Severity (CGI-S) Score
Among the most extremely ill
|
0 participants
|
0 participants
|
|
Clinical Global Impression of Severity (CGI-S) Score
Not assessed
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Weeks 1 through Week 8Population: Intent-to-Treat (ITT) population included all randomized subjects who had received at least 1 dose of the double-blind treatment, and had a baseline and post-baseline efficacy assessment.
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.
Outcome measures
| Measure |
Pregabalin
n=177 Participants
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
n=176 Participants
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).
|
|---|---|---|
|
Change in Hamilton Depression Rating Scale (HAM-D) Total Score
Week 1 n=165,168
|
-2.1 score on scale
Standard Error 0.28
|
-1.3 score on scale
Standard Error 0.28
|
|
Change in Hamilton Depression Rating Scale (HAM-D) Total Score
Week 2 n=165,164
|
-3.1 score on scale
Standard Error 0.30
|
-2.4 score on scale
Standard Error 0.31
|
|
Change in Hamilton Depression Rating Scale (HAM-D) Total Score
Week 3 n=156,160
|
-3.5 score on scale
Standard Error 0.32
|
-2.8 score on scale
Standard Error 0.32
|
|
Change in Hamilton Depression Rating Scale (HAM-D) Total Score
Week 4 n=153, 149
|
-4.7 score on scale
Standard Error 0.29
|
-3.3 score on scale
Standard Error 0.29
|
|
Change in Hamilton Depression Rating Scale (HAM-D) Total Score
Week 5 n=135, 130
|
-4.3 score on scale
Standard Error 0.33
|
-3.9 score on scale
Standard Error 0.34
|
|
Change in Hamilton Depression Rating Scale (HAM-D) Total Score
Week 6 n=122, 125
|
-4.7 score on scale
Standard Error 0.33
|
-3.8 score on scale
Standard Error 0.33
|
|
Change in Hamilton Depression Rating Scale (HAM-D) Total Score
Week 8 n= 126, 127
|
-4.8 score on scale
Standard Error 0.40
|
-3.8 score on scale
Standard Error 0.40
|
Adverse Events
Pregabalin
Serious events: 1 serious events
Other events: 81 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
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).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease (COPD)
|
0.56%
1/180
|
0.00%
0/176
|
|
Psychiatric disorders
Depression
|
0.00%
0/180
|
0.57%
1/176
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/180
|
0.57%
1/176
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/180
|
0.57%
1/176
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/180
|
0.57%
1/176
|
|
Cardiac disorders
Cardiac failure congestive
|
0.56%
1/180
|
0.00%
0/176
|
|
Infections and infestations
Cellulitis
|
0.56%
1/180
|
0.00%
0/176
|
Other adverse events
| Measure |
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).
|
|---|---|---|
|
Psychiatric disorders
Insomnia
|
2.8%
5/180
|
0.57%
1/176
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
2/180
|
3.4%
6/176
|
|
Eye disorders
Vision blurred
|
4.4%
8/180
|
1.1%
2/176
|
|
Gastrointestinal disorders
Constipation
|
2.8%
5/180
|
1.7%
3/176
|
|
Gastrointestinal disorders
Diarrhea
|
3.9%
7/180
|
4.0%
7/176
|
|
Gastrointestinal disorders
Dry mouth
|
2.2%
4/180
|
1.1%
2/176
|
|
Gastrointestinal disorders
Dyspepsia
|
3.3%
6/180
|
0.57%
1/176
|
|
Gastrointestinal disorders
Flatulence
|
2.2%
4/180
|
0.00%
0/176
|
|
Gastrointestinal disorders
Nausea
|
7.2%
13/180
|
4.5%
8/176
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
2/180
|
2.3%
4/176
|
|
General disorders
Fatigue
|
3.9%
7/180
|
2.8%
5/176
|
|
Infections and infestations
Nasopharyngitis
|
2.8%
5/180
|
3.4%
6/176
|
|
Infections and infestations
Upper respiratory tract infection
|
1.7%
3/180
|
3.4%
6/176
|
|
Investigations
Weight increased
|
2.2%
4/180
|
0.00%
0/176
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.8%
5/180
|
0.57%
1/176
|
|
Nervous system disorders
Dizziness
|
11.7%
21/180
|
5.7%
10/176
|
|
Nervous system disorders
Headache
|
9.4%
17/180
|
4.0%
7/176
|
|
Nervous system disorders
Paraesthesia
|
2.2%
4/180
|
0.57%
1/176
|
|
Nervous system disorders
Sedation
|
3.9%
7/180
|
4.0%
7/176
|
|
Nervous system disorders
Somnolence
|
8.3%
15/180
|
3.4%
6/176
|
|
Psychiatric disorders
Euphoric mood
|
2.2%
4/180
|
0.00%
0/176
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
- Publication restrictions are in place
Restriction type: OTHER