Phase 4
N=615
Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder
Generalized Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00624780 ↗Enrolled (actual)
615
Serious AEs
2.1%
Results posted
Apr 2013
Primary outcome: Primary: Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 — 25.8; 24.9; 24.4; -7.7 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pregabalin (Drug); Lorazepam (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 |
25.8; 24.9; 24.4; -7.7; -5.9; -9.9 | — |
| PRIMARY Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2 |
-12.0; -5.9; -9.7 | — |
| PRIMARY Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 |
25.0; 24.7; 24.6; -15.3; -15.3; -15.8 | — |
| PRIMARY Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2 |
-15.6; -14.9; -16.0 | — |
| PRIMARY Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 |
25.5; 24.2; 24.7; 24.9; 24.6; 24.9 | — |
| PRIMARY Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2 |
-16.6; -19.1; -18.3; -16.0; -16.7; -18.7 | — |
| 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 |
10.1; 16.8; 13.1; 0.1; -2.8; -4.2 | — |
| 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 |
-2.0; -2.7; -3.2 | — |
| 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 |
7.2; 6.5; 5.0; 1.9; 1.4; 2.3 | — |
| 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 |
2.1; 2.0; 1.6 | — |
| PRIMARY Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 |
5.2; 4.9; 3.9; 6.5; 5.3; 4.7 | — |
| PRIMARY Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2 |
2.8; -1.0; 1.7; 1.8; 2.2; -0.1 | — |
| SECONDARY Number of Participants With Rebound Anxiety for Cohort 1 (Less Than 3-Month Last Visit) |
1; 5; 1 | — |
| SECONDARY Number of Participants With Rebound Anxiety for Cohort 2 (3-Month Last Visit) |
3; 1; 2 | — |
| SECONDARY Number of Participants With Rebound Anxiety for Cohort 3 (6-Month Last Visit) |
4; 0; 0; 1; 6; 0 | — |
| SECONDARY Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 1 (Less Than 3-Month Last Visit) |
6; 0; 3; 0; 0; 0 | — |
| SECONDARY Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 2 (3-Month Last Visit) |
40; 38; 36; 1; 2; 1 | — |
| SECONDARY Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 3 (6-Month Last Visit) |
78; 5; 35; 17; 50; 7 | — |
| SECONDARY Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 and 2 |
13.6; 17.6; 16.4; -3.4; -3.3; -5.9 | — |
| SECONDARY Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 and 2 |
17.4; 17.1; 14.8; -8.5; -9.3; -7.6 | — |
| SECONDARY Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 and 2 |
17.8; 17.8; 16.1; 17.4; 16.8; 14.9 | — |
| SECONDARY Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) |
10.2; 14.3; 9.1; 8.2; 14.1; 10.6 | — |
| SECONDARY Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) |
9.1; 8.0; 7.3; 8.9; 8.3; 6.9 | — |
| SECONDARY Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) |
6.8; 4.9; 5.1; 7.4; 8.0; 4.6 | — |
| SECONDARY Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 and 2 |
16.1; 21.6; 16.1; 2.0; -2.3; -2.4 | — |
| SECONDARY Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 and 2 |
8.0; 8.5; 6.7; 1.7; 0.9; 2.3 | — |
| SECONDARY Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 and 2 |
6.3; 5.5; 5.6; 8.3; 5.6; 5.5 | — |
| SECONDARY Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) |
18.1; 19.0; 14.1; 13.9; 18.6; 14.6 | — |
| SECONDARY Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) |
9.6; 9.4; 8.8; 9.0; 9.9; 8.3 | — |
| SECONDARY Hamilton Anxiety Scale (HAM-A) Score for Cohort 3 (6-Month Last Visit) |
7.9; 5.5; 6.3; 8.4; 8.4; 7.07 | — |
| SECONDARY Hamilton Anxiety Scale (HAM-A) Score for Period 1 |
25.3; 24.9; 24.5; 8.0; 8.9; 7.9 | — |
| SECONDARY Hamilton Anxiety Scale (HAM-A) Score for Period 2 |
25.6; 24.6; 24.8; 25.1; 24.7; 24.1 | — |
| SECONDARY Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 12 |
-17.4; -16.0; -16.7 | — |
| SECONDARY Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 24 |
-18.7; -17.5; -18.2; -14.9; -19.0; -17.5 | — |
| SECONDARY Clinical Global Impression - Severity (CGI-S) Score for Period 1 |
4.6; 4.5; 4.4; 2.3; 2.5; 2.3 | — |
| SECONDARY Clinical Global Impression - Severity (CGI-S) Score for Period 2 |
4.7; 4.5; 4.5; 4.5; 4.4; 4.5 | — |
| SECONDARY Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12 |
-2.3; -2.1; -2.1 | — |
| SECONDARY Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 24 |
-2.4; -2.3; -2.4; -2.0; -2.5; -2.2 | — |
| SECONDARY Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 1 |
1.9; 1.9; 1.9 | — |
| SECONDARY Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 2 |
1.7; 1.9; 1.6; 2.3; 1.5; 2.0 | — |
Summary
The purpose of this study is to characterize the safety and efficacy in patients with generalized anxiety disorder after short- (3 months) and long-term (6 months) use of Pregabalin (Lyrica).
Eligibility Criteria
Inclusion Criteria
- Diagnosis Generalized Anxiety Disorder
- HAM-A score >=18 and HAM-D (item 1) score >=2 at screening and baseline
- Needs pharmacological treatment
Exclusion Criteria
- Current or past diagnosis of any other DSM IV Axis I disorders
- A history of failed treatment with a benzodiazepine
- Any clinically significant, serious, or unstable hematologic, autoimmune, endocrine, cardiovascular, renal, hepatic, gastrointestinal, or neurological disorder
Data sourced from ClinicalTrials.gov (NCT00624780). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.