Trial · NCT00413010
Pregabalin in the Treatment of Patients With Generalized Anxiety Disorder (GAD).
NCT00413010, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2009-12-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pregabalin in the Treatment of Patients With Generalized Anxiety Disorder (GAD). Trials, record NCT00413010. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00413010
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pregabalin in the Treatment of Patients With Generalized Anxiety Disorder (GAD).
- NCT number
- NCT00413010
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 356 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Generalized Anxiety Disorder
- Interventions
- pregabalin, placebo
- First posted
- 2006-12-19
- Last updated
- 2021-02-10
- Results first posted
- 2009-12-02
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores | Baseline, 8 weeks | 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. |
| Secondary | Change in HAM-A Total Score at Weekly Visits | Baseline, Weeks 1 through Week 8 | 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. |
| Secondary | Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A) | Weeks 1 through Week 8 | 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. |
| Secondary | Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score | Week 1 through Week 8 | 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. |
| Secondary | Time to Onset of Sustained Hamilton Anxiety Rating Scale (HAM-A) Improvement | Week 8 | 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. |
| Secondary | Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score | Week 1 through Week 8 | 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). |
| Secondary | Clinical Global Impression of Severity (CGI-S) Score | Week 8 | 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. |
| Secondary | Change in Hamilton Depression Rating Scale (HAM-D) Total Score | Weeks 1 through Week 8 | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores | Baseline, 8 weeks | 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. | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in HAM-A Total Score at Weekly Visits | Baseline, Weeks 1 through Week 8 | 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. | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A) | Weeks 1 through Week 8 | 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. | participants | NUMBER |
| SECONDARY | Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score | Week 1 through Week 8 | 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. | participants | NUMBER |
| SECONDARY | Time to Onset of Sustained Hamilton Anxiety Rating Scale (HAM-A) Improvement | Week 8 | 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. | days | MEDIAN |
| SECONDARY | Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score | Week 1 through Week 8 | 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. | participants | NUMBER |
| SECONDARY | Clinical Global Impression of Severity (CGI-S) Score | Week 8 | 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. | participants | NUMBER |
| SECONDARY | Change in Hamilton Depression Rating Scale (HAM-D) Total Score | Weeks 1 through Week 8 | 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. | score on scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group143
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores | Pregabalin | -7.6 | Standard Error 0.35 | score on scale | |
| Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores | Placebo | -6.4 | Standard Error 0.36 | score on scale | |
| Change in HAM-A Total Score at Weekly Visits | Pregabalin | Week 1 (n=164;n=169) | -4.4 | Standard Error 0.37 | score on scale |
| Change in HAM-A Total Score at Weekly Visits | Placebo | Week 1 (n=164;n=169) | -3.1 | Standard Error 0.37 | score on scale |
| Change in HAM-A Total Score at Weekly Visits | Pregabalin | Week 2 (n=166;n=163) | -6.3 | Standard Error 0.43 | score on scale |
| Change in HAM-A Total Score at Weekly Visits | Placebo | Week 2 (n=166;n=163) | -5.2 | Standard Error 0.43 | score on scale |
| Change in HAM-A Total Score at Weekly Visits | Pregabalin | Week 3 (n=157;n=160) | -7.0 | Standard Error 0.45 | score on scale |
| Change in HAM-A Total Score at Weekly Visits | Placebo | Week 3 (n=157;n=160) | -5.5 | Standard Error 0.45 | score on scale |
| Change in HAM-A Total Score at Weekly Visits | Pregabalin | Week 4 (n=153;n=150) | -8.3 | Standard Error 0.46 | score on scale |
| Change in HAM-A Total Score at Weekly Visits | Placebo | Week 4 (n=153;n=150) | -7.0 | Standard Error 0.47 | score on scale |
1 to 10 of 143Source ClinicalTrials.gov
See all 143 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pregabalin | 180 | |
| Overall Study | STARTED | Placebo | 176 | |
| Overall Study | COMPLETED | Pregabalin | 108 | |
| Overall Study | COMPLETED | Placebo | 113 | |
| Overall Study | NOT COMPLETED | Pregabalin | 72 | |
| Overall Study | NOT COMPLETED | Placebo | 63 |
Source ClinicalTrials.gov
Adverse events56
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vision blurred | Eye disorders | Pregabalin | 8 | 180 | |
| other | Vision blurred | Eye disorders | Placebo | 2 | 176 | |
| other | Constipation | Gastrointestinal disorders | Pregabalin | 5 | 180 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 3 | 176 | |
| other | Diarrhea | Gastrointestinal disorders | Pregabalin | 7 | 180 | |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 7 | 176 | |
| other | Dry mouth | Gastrointestinal disorders | Pregabalin | 4 | 180 | |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 2 | 176 | |
| other | Dyspepsia | Gastrointestinal disorders | Pregabalin | 6 | 180 | |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 1 | 176 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pregabalin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Pregabalin | 81 | |
| Total, other adverse events | Placebo | 59 | |
| Total, serious adverse events | Pregabalin | 1 | |
| Total, serious adverse events | Placebo | 3 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22302014 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00413010
GET https://conductscience.org/api/trials/v1/NCT00413010/results?page=2