Trial · NCT00368745
Efficacy and Safety of Pregabalin vs Placebo for Generalized Anxiety Disorder (GAD) Symptoms in Subjects Discontinuing Benzodiazepine Treatment and Remaining 6 Weeks on Study Medication, Free From Benzodiazepine Use.
NCT00368745, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2009-11-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Pregabalin vs Placebo for Generalized Anxiety Disorder (GAD) Symptoms in Subjects Discontinuing Benzodiazepine Treatment and Remaining 6 Weeks on Study Medication, Free From Benzodiazepine Use. Trials, record NCT00368745. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00368745
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Efficacy and Safety of Pregabalin vs Placebo for Generalized Anxiety Disorder (GAD) Symptoms in Subjects Discontinuing Benzodiazepine Treatment and Remaining 6 Weeks on Study Medication, Free From Benzodiazepine Use.
- NCT number
- NCT00368745
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 108 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Generalized Anxiety Disorder
- Interventions
- Pregabalin, Placebo
- First posted
- 2006-08-25
- Last updated
- 2021-02-09
- Results first posted
- 2009-11-09
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects at Endpoint (Post Alprazolam Free Week 6 or Last Observation Carried Forward [LOCF] Post Alprazolam Free Week 1) Who Are Benzodiazepine Free | Endpoint (Post Alprazolam Free Week 6 or LOCF Post Alprazolam Free Week 1) | Number of subjects benzodiazepine free: \< 2 doses rescue medication; negative urine benzodiazepine psychoactive toxicology assay (each visit Alprazolam Free phase); negative serum benzodiazepine alcohol assay (endpoint or LOCF). |
| Secondary | Mean Change From Baseline in Hamilton Anxiety Scale (HAM-A) Scores | Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (Alprazolam Free [AF] Week 6) | HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); lower score indicates less affected. Change from baseline: mean at observation minus mean at baseline. |
| Secondary | Number of Subjects With > = 6 Point Increase in Physician's Withdrawal Checklist (PWC) Scores | Baseline, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6) | PWC: 20 item physician rated interview (0 = not present; 3 = severe; score range: 0 to 60) measuring: signs of anxiolytic drug withdrawal and gastrointestinal (GI), mood, sleep, motor, somatic, perception and cognition symptoms. Data not analyzed: PWC not measured at baseline. |
| Secondary | Number of Subjects With > = 5 New PWC Symptoms | Baseline, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6) | PWC: 20 item physician rated interview (0 = not present; 3 = severe; score range: 0 to 60) measuring: signs of anxiolytic drug withdrawal and gastrointestinal (GI), mood, sleep, motor, somatic, perception and cognition symptoms. Data not analyzed: PWC not measured at baseline. |
| Secondary | Mean Change From Baseline in Physician's Withdrawal Checklist (PWC) Scores | Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6) | PWC: 20 item physician rated interview (0 = not present; 3 = severe; score range: 0 to 60) measuring: signs of anxiolytic drug withdrawal and gastrointestinal (GI), mood, sleep, motor, somatic, perception and cognition symptoms. Change from baseline not analyzed as PWC was not measured at baseline. Mean PWS scores presented in Post-hoc outcome measure Mean PWS scores. |
| Secondary | Mean Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale Scores. | Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 ) | CGI-S: 7-point scale to assess global change in subject condition compared to baseline; range 1 (no evidence of illness) to 7 (among the most severely ill); higher score = more affected. Change from baseline: mean at observation minus mean at baseline. |
| Secondary | Mean Scores for Clinical Global Impression-Improvement (CGI-I) Scale | Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 ) | CGI-I: 7-point scale to assess global change in subject condition compared to baseline; range 1 (very much improved) to 7 (very much worse); higher score = more affected. |
| Secondary | Mean Scores for Patient Global Impression-Improvement (PGI-I) | Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 ) | PGI-I: subject rated 7-point scale measures change in overall status; range 1 (very much improved) to 7 (very much worse). |
| Secondary | Mean Change From Baseline in Digit Symbol Substitution Test (DSST) Scores | Baseline, Endpoint (AF Week 6 ) | DSST: subject-rated; evaluates aspects of cognition (includes attending to directions, processing speed, sustained attention, visual-motor integration, learning and psychomotor speed). Subject matches symbol (1 to 9) with corresponding number key (1 to 9); number of correct symbol-number pairs completed by subject over a 90-second test period determines DSST score. Change: mean at observation minus mean at baseline. Data summarized as change from baseline to endpoint. |
| Secondary | Time to Discontinuation | Baseline, Week 13 (Final Visit/Early Termination) | The 25th percentile estimate of time until discontinuation is based on Kaplan-Meier estimates. Event day is the study day when the subject discontinued from study. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects at Endpoint (Post Alprazolam Free Week 6 or Last Observation Carried Forward [LOCF] Post Alprazolam Free Week 1) Who Are Benzodiazepine Free | Endpoint (Post Alprazolam Free Week 6 or LOCF Post Alprazolam Free Week 1) | Intent to Treat (ITT) population: received at least 1 dose pregabalin or placebo. Primary outcome ITT = all treated subjects in alprazolam free phase. Endpoint = Post Alprazolam Free Week 6 or LOCF Post Alprazolam Free Week 1. | participants | NUMBER |
| SECONDARY | Mean Change From Baseline in Hamilton Anxiety Scale (HAM-A) Scores | Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (Alprazolam Free [AF] Week 6) | ITT; subject has a baseline and at least 1 post-baseline measurement before week 13; endpoint = AF Week 6 or LOCF; (n) = number of subjects with data for analysis for pregabalin and placebo, respectively. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Subjects With > = 6 Point Increase in Physician's Withdrawal Checklist (PWC) Scores | Baseline, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6) | ITT; data not analyzed: PWC not measured at baseline. | ||
| SECONDARY | Number of Subjects With > = 5 New PWC Symptoms | Baseline, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6) | ITT; data not analyzed: PWC not measured at baseline. | ||
| POST_HOC | Mean Scores Physician's Withdrawal Checklist (PWC) | Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6 ) | ITT; (n) = number of subjects with data for analysis for pregabalin and placebo, respectively. Endpoint = AF Week 6 or LOCF. Refer to measure Mean Change From Baseline in Physician's Withdrawal Checklist (PWC) Scores. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Physician's Withdrawal Checklist (PWC) Scores | Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6) | ITT; Change from baseline not analyzed as PWC was not measured at baseline. Mean PWS scores presented in Post-hoc outcome measure Mean PWS scores. | ||
| SECONDARY | Mean Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale Scores. | Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 ) | ITT; subject has a baseline and at least 1 post-baseline endpoint measurement; endpoint = AF Week 6 or LOCF; (n) = number of subjects with data for analysis for pregabalin and placebo, respectively. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Scores for Clinical Global Impression-Improvement (CGI-I) Scale | Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 ) | ITT; subject has a baseline and endpoint measurement; endpoint = AF Week 6 or LOCF; (n) = number of subjects with data for analysis for pregabalin and placebo, respectively. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Scores for Patient Global Impression-Improvement (PGI-I) | Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 ) | ITT; endpoint = AF Week 6 or LOCF; (n) = number of subjects with data for analysis for pregabalin and placebo, respectively. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Digit Symbol Substitution Test (DSST) Scores | Baseline, Endpoint (AF Week 6 ) | ITT; subject has baseline and endpoint (final visit) measurement; endpoint = AF Week 6 or LOCF. | scores on scale | LEAST_SQUARES_MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group140
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects at Endpoint (Post Alprazolam Free Week 6 or Last Observation Carried Forward [LOCF] Post Alprazolam Free Week 1) Who Are Benzodiazepine Free | Pregabalin 75 mg to 300 mg PO BID | 20 | participants | ||
| Number of Subjects at Endpoint (Post Alprazolam Free Week 6 or Last Observation Carried Forward [LOCF] Post Alprazolam Free Week 1) Who Are Benzodiazepine Free | Placebo 75 mg to 300 mg PO BID | 10 | participants | ||
| Mean Change From Baseline in Hamilton Anxiety Scale (HAM-A) Scores | Pregabalin 75 mg to 300 mg PO BID | Alprazolam Taper (AT) Week 1 (n=46, 40) | -0.82 | Standard Error 0.66 | scores on scale |
| Mean Change From Baseline in Hamilton Anxiety Scale (HAM-A) Scores | Placebo 75 mg to 300 mg PO BID | Alprazolam Taper (AT) Week 1 (n=46, 40) | 0.67 | Standard Error 0.81 | scores on scale |
| Mean Change From Baseline in Hamilton Anxiety Scale (HAM-A) Scores | Pregabalin 75 mg to 300 mg PO BID | AT Week 2 (n=45, 37) | -1.72 | Standard Error 0.98 | scores on scale |
| Mean Change From Baseline in Hamilton Anxiety Scale (HAM-A) Scores | Placebo 75 mg to 300 mg PO BID | AT Week 2 (n=45, 37) | 2.17 | Standard Error 1.15 | scores on scale |
| Mean Change From Baseline in Hamilton Anxiety Scale (HAM-A) Scores | Pregabalin 75 mg to 300 mg PO BID | AT Week 3 (n=33, 26) | -2.59 | Standard Error 0.99 | scores on scale |
| Mean Change From Baseline in Hamilton Anxiety Scale (HAM-A) Scores | Placebo 75 mg to 300 mg PO BID | AT Week 3 (n=33, 26) | -0.21 | Standard Error 1.32 | scores on scale |
| Mean Change From Baseline in Hamilton Anxiety Scale (HAM-A) Scores | Pregabalin 75 mg to 300 mg PO BID | AT Week 4 (n=18, 11) | -1.47 | Standard Error 1.11 | scores on scale |
| Mean Change From Baseline in Hamilton Anxiety Scale (HAM-A) Scores | Placebo 75 mg to 300 mg PO BID | AT Week 4 (n=18, 11) | 1.91 | Standard Error 1.82 | scores on scale |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomized to Double-blind Treatment | STARTED | Pregabalin 75 mg to 300 mg PO BID | 57 | |
| Randomized to Double-blind Treatment | STARTED | Placebo 75 mg to 300 mg PO BID | 51 | |
| Randomized to Double-blind Treatment | COMPLETED | Pregabalin 75 mg to 300 mg PO BID | 56 | |
| Randomized to Double-blind Treatment | COMPLETED | Placebo 75 mg to 300 mg PO BID | 50 | |
| Randomized to Double-blind Treatment | NOT COMPLETED | Pregabalin 75 mg to 300 mg PO BID | 1 | |
| Randomized to Double-blind Treatment | NOT COMPLETED | Placebo 75 mg to 300 mg PO BID | 1 | |
| Double-blind Treatment Period | STARTED | Pregabalin 75 mg to 300 mg PO BID | 56 | |
| Double-blind Treatment Period | STARTED | Placebo 75 mg to 300 mg PO BID | 50 | |
| Double-blind Treatment Period | COMPLETED | Pregabalin 75 mg to 300 mg PO BID | 30 | |
| Double-blind Treatment Period | COMPLETED | Placebo 75 mg to 300 mg PO BID | 19 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events36
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 | Hyperacusis | Ear and labyrinth disorders | Pregabalin 75 mg to 300 mg PO BID | 3 | 56 | |
| other | Hyperacusis | Ear and labyrinth disorders | Placebo 75 mg to 300 mg PO BID | 1 | 50 | |
| other | Vision blurred | Eye disorders | Pregabalin 75 mg to 300 mg PO BID | 5 | 56 | |
| other | Vision blurred | Eye disorders | Placebo 75 mg to 300 mg PO BID | 2 | 50 | |
| other | Diarrhoea | Gastrointestinal disorders | Pregabalin 75 mg to 300 mg PO BID | 3 | 56 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo 75 mg to 300 mg PO BID | 5 | 50 | |
| other | Nausea | Gastrointestinal disorders | Pregabalin 75 mg to 300 mg PO BID | 5 | 56 | |
| other | Nausea | Gastrointestinal disorders | Placebo 75 mg to 300 mg PO BID | 7 | 50 | |
| other | Vomiting | Gastrointestinal disorders | Pregabalin 75 mg to 300 mg PO BID | 3 | 56 | |
| other | Vomiting | Gastrointestinal disorders | Placebo 75 mg to 300 mg PO BID | 0 | 50 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pregabalin 75 mg to 300 mg PO BID | ||
| Total, all-cause mortality | Placebo 75 mg to 300 mg PO BID | ||
| Total, other adverse events | Pregabalin 75 mg to 300 mg PO BID | 33 | 56 |
| Total, other adverse events | Placebo 75 mg to 300 mg PO BID | 29 | 50 |
| Total, serious adverse events | Pregabalin 75 mg to 300 mg PO BID | 0 | 56 |
| Total, serious adverse events | Placebo 75 mg to 300 mg PO BID | 0 | 50 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Pregabalin 75 mg to 300 mg PO BID vs Placebo 75 mg to 300 mg PO BID: Number of Subjects at Endpoint (Post Alprazolam Free Week 6 or Last Observation Carried Forward [LOCF] Post Alprazolam Free Week 1) Who Are Benzodiazepine Free | Trial comparisons |
| Pregabalin 75 mg to 300 mg PO BID vs Placebo 75 mg to 300 mg PO BID: Number of Subjects in Relapse Free State at 6-week Benzodiazepine-free Endpoint (Alprazolam Free Week 6) | Trial comparisons |
| Pregabalin 75 mg to 300 mg PO BID vs Placebo 75 mg to 300 mg PO BID: serious adverse events | Trial comparisons |
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Symbol Coding | Secondary outcome |
Source ConductCognition
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/NCT00368745
GET https://conductscience.org/api/trials/v1/NCT00368745/results?page=2