Phase 3
N=108
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.
Generalized Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00368745 ↗Enrolled (actual)
108
Serious AEs
0.0%
Results posted
Nov 2009
Primary outcome: 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 — 20; 10 participants — p=0.2838
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pregabalin (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
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
20; 10 | 0.2838 |
| SECONDARY Mean Change From Baseline in Hamilton Anxiety Scale (HAM-A) Scores |
-0.82; 0.67; -1.72; 2.17; -2.59; -0.21 | 0.0709 |
| SECONDARY Number of Subjects With > = 6 Point Increase in Physician's Withdrawal Checklist (PWC) Scores |
— | — |
| SECONDARY Number of Subjects With > = 5 New PWC Symptoms |
— | — |
| SECONDARY Mean Change From Baseline in Physician's Withdrawal Checklist (PWC) Scores |
— | — |
| SECONDARY Mean Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale Scores. |
-0.23; 0.22; -0.33; 0.41; -0.60; -0.10 | 0.0052 sig |
| SECONDARY Mean Scores for Clinical Global Impression-Improvement (CGI-I) Scale |
3.52; 3.90; 3.17; 3.98; 2.88; 3.47 | 0.1260 |
| SECONDARY Mean Scores for Patient Global Impression-Improvement (PGI-I) |
3.16; 3.82; 3.13; 4.03; 2.93; 3.31 | 0.0226 sig |
| SECONDARY Mean Change From Baseline in Digit Symbol Substitution Test (DSST) Scores |
13.10; 13.47 | 0.8897 |
| SECONDARY Time to Discontinuation |
51; 33 | 0.0626 |
| SECONDARY Time to First Use of Rescue Medication |
63; 30 | 0.0148 sig |
| SECONDARY Number of Subjects in Relapse Free State at 6-week Benzodiazepine-free Endpoint (Alprazolam Free Week 6) |
21; 12 | 0.1159 |
Summary
GAD subjects maintained on a stable dose of alprazolam for at least four weeks who meet eligibility criteria will be randomized to receive pregabalin vs matching placebo while simultaneously tapering off of alprazolam over 6 weeks. Subjects return weekly for assessment of safety/tolerability of pregabalin vs placebo as well as for assessment of anxiety and benzodiazepine withdrawal symptoms. Subjects successfully able to discontinue alprazolam, will continue 6 weeks of treatment with pregabalin vs placebo (free of benzodiazepine use). The efficacy and safety of pregabalin vs placebo for anxiety symptoms and ability to discontinue/remain free of alprazolam will be compared among pregabalin and placebo treated groups. Hypothesis is that a greater proportion of subjects will be successful in discontinuing and remaining free from benzodiazepines who were treated with pregabalin as compared to subjects treated with placebo.
Eligibility Criteria
Inclusion Criteria
- Provide written informed consent
- 18-65 years old
- male and female
- A primary lifetime diagnosis of DSM-IV-TR (2000) GAD (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition)
Exclusion Criteria
- Pregnant or lactating women
- History of non-response to alprazolam, other benzodiazepines, gabapentin or pregabalin given for the treatment of anxiety as indicated by a (screening or baseline) Hamilton Anxiety Scale (HAM-A) score > 18
Data sourced from ClinicalTrials.gov (NCT00368745). 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.