Trial · NCT00624780
Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder
NCT00624780, Phase 4, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2013-04-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder. Trials, record NCT00624780. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00624780
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder
- NCT number
- NCT00624780
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 615 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Generalized Anxiety Disorder
- Interventions
- Pregabalin, Lorazepam, Pregabalin, Placebo
- First posted
- 2008-02-27
- Last updated
- 2021-01-28
- Results first posted
- 2013-04-19
Source ClinicalTrials.gov
Registered outcomes42
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 | Baseline, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9) | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. |
| Primary | Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2 | Baseline, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9) | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. |
| Primary | Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 | Baseline, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. |
| Primary | Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2 | Baseline, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. |
| Primary | Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 | Baseline, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24) | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. |
| Primary | Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2 | Baseline, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24) | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected. |
| Primary | Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 | Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9) | PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. |
| Primary | Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2 | Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9) | PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. |
| Primary | Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 | Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) | PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. |
| Primary | Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2 | Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) | PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 registered outcomesOutcomes42
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 | Baseline, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9) | Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included. n=participants evaluable at given time points for each group. | units on a scale | MEAN |
| PRIMARY | Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2 | Baseline, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9) | Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. | units on a scale | MEAN |
| PRIMARY | Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 | Baseline, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) | Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. | units on a scale | MEAN |
| PRIMARY | Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2 | Baseline, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) | Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. | units on a scale | MEAN |
| PRIMARY | Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 | Baseline, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24) | Per-protocol analysis set: all randomized participants who had baseline with at least 1 discontinuation or efficacy visit, and were not major protocol violators. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis. | units on a scale | MEAN |
| PRIMARY | Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2 | Baseline, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24) | Per-protocol analysis set. Cohort 3: Participants who discontinued study after Week 15 or completed Week 24 visit and had at least 1 discontinuation assessment were included in Month 6 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. | units on a scale | MEAN |
| PRIMARY | Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 | Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9) | Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. N (Number of Participants Analyzed) = participants evaluable for this measure. 'n' = participants evaluable at given time points for each group respectively. | units on a scale | MEAN |
| PRIMARY | Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2 | Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9) | Per-protocol analysis set. Cohort 1: Participants who discontinued study prior to Week 9 and had at least 1 discontinuation assessment were included in less-than Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants evaluable for this measure. | units on a scale | MEAN |
| PRIMARY | Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 | Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) | Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. | units on a scale | MEAN |
| PRIMARY | Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2 | Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) | Per-protocol analysis set. Cohort 2: Participants who discontinued study from Week 9 to Week 15 and had at least 1 discontinuation assessment were included in Month 3 last visit analysis. Here, N (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. | units on a scale | MEAN |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 outcomesResults by group303
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 | Pregabalin High Dose | Baseline (n=15,19,21) | 25.8 | Standard Deviation 4.23 | units on a scale |
| Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 | Pregabalin Low Dose | Baseline (n=15,19,21) | 24.9 | Standard Deviation 4.15 | units on a scale |
| Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 | Lorazepam | Baseline (n=15,19,21) | 24.4 | Standard Deviation 4.88 | units on a scale |
| Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 | Pregabalin High Dose | Change at Discontinuation Week 1 (n=15,19,18) | -7.7 | Standard Deviation 6.75 | units on a scale |
| Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 | Pregabalin Low Dose | Change at Discontinuation Week 1 (n=15,19,18) | -5.9 | Standard Deviation 7.20 | units on a scale |
| Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 | Lorazepam | Change at Discontinuation Week 1 (n=15,19,18) | -9.9 | Standard Deviation 10.81 | units on a scale |
| Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2 | Pregabalin High Dose | -12.0 | Standard Deviation 7.24 | units on a scale | |
| Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2 | Pregabalin Low Dose | -5.9 | Standard Deviation 5.46 | units on a scale | |
| Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2 | Lorazepam | -9.7 | Standard Deviation 11.08 | units on a scale | |
| Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 | Pregabalin High Dose | Baseline | 25.0 | Standard Deviation 5.37 | units on a scale |
1 to 10 of 303Source ClinicalTrials.gov
See all 303 results by groupParticipant flow72
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Optimization (Up to Week 12) | STARTED | Pregabalin High Dose, Pregabalin High Dose | 154 | |
| Treatment Optimization (Up to Week 12) | STARTED | Pregabalin High Dose, Placebo | 52 | |
| Treatment Optimization (Up to Week 12) | STARTED | Pregabalin Low Dose, Pregabalin Low Dose | 154 | |
| Treatment Optimization (Up to Week 12) | STARTED | Pregabalin Low Dose, Placebo | 52 | |
| Treatment Optimization (Up to Week 12) | STARTED | Lorazepam, Lorazepam | 153 | |
| Treatment Optimization (Up to Week 12) | STARTED | Lorazepam, Placebo | 50 | |
| Treatment Optimization (Up to Week 12) | COMPLETED | Pregabalin High Dose, Pregabalin High Dose | 121 | |
| Treatment Optimization (Up to Week 12) | COMPLETED | Pregabalin High Dose, Placebo | 39 | |
| Treatment Optimization (Up to Week 12) | COMPLETED | Pregabalin Low Dose, Pregabalin Low Dose | 112 | |
| Treatment Optimization (Up to Week 12) | COMPLETED | Pregabalin Low Dose, Placebo | 38 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 participant flowAdverse events264
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 | Vertigo | Ear and labyrinth disorders | Pregabalin High Dose, Pregabalin High Dose | 4 | 154 | |
| other | Vertigo | Ear and labyrinth disorders | Pregabalin High Dose, Placebo | 1 | 52 | |
| other | Vertigo | Ear and labyrinth disorders | Pregabalin Low Dose, Pregabalin Low Dose | 5 | 154 | |
| other | Vertigo | Ear and labyrinth disorders | Pregabalin Low Dose, Placebo | 4 | 52 | |
| other | Vertigo | Ear and labyrinth disorders | Lorazepam, Lorazepam | 3 | 153 | |
| other | Vertigo | Ear and labyrinth disorders | Lorazepam, Placebo | 1 | 50 | |
| other | Abdominal pain | Gastrointestinal disorders | Pregabalin High Dose, Pregabalin High Dose | 1 | 154 | |
| other | Abdominal pain | Gastrointestinal disorders | Pregabalin High Dose, Placebo | 1 | 52 | |
| other | Abdominal pain | Gastrointestinal disorders | Pregabalin Low Dose, Pregabalin Low Dose | 2 | 154 | |
| other | Abdominal pain | Gastrointestinal disorders | Pregabalin Low Dose, Placebo | 3 | 52 |
1 to 10 of 264Source ClinicalTrials.gov
See all 264 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pregabalin High Dose, Pregabalin High Dose | ||
| Total, all-cause mortality | Pregabalin High Dose, Placebo | ||
| Total, all-cause mortality | Pregabalin Low Dose, Pregabalin Low Dose | ||
| Total, all-cause mortality | Pregabalin Low Dose, Placebo | ||
| Total, all-cause mortality | Lorazepam, Lorazepam | ||
| Total, all-cause mortality | Lorazepam, Placebo | ||
| Total, other adverse events | Pregabalin High Dose, Pregabalin High Dose | 110 | 154 |
| Total, other adverse events | Pregabalin High Dose, Placebo | 40 | 52 |
| Total, other adverse events | Pregabalin Low Dose, Pregabalin Low Dose | 108 | 154 |
| Total, other adverse events | Pregabalin Low Dose, Placebo | 38 | 52 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24351233 | 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.
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