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.
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00368745
First received: August 23, 2006
Last updated: November 9, 2009
Last verified: November 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Generalized Anxiety Disorder |
Drug: Pregabalin Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Pregabalin in Subjects With Generalized Anxiety Disorder (GAD) Switching From Benzodiazepine Therapy. |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 [ Time Frame: Endpoint (Post Alprazolam Free Week 6 or LOCF Post Alprazolam Free Week 1) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Mean Change From Baseline in Hamilton Anxiety Scale (HAM-A) Scores [ Time Frame: Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (Alprazolam Free [AF] Week 6) ] [ Designated as safety issue: No ]
- Number of Subjects With > = 6 Point Increase in Physician's Withdrawal Checklist (PWC) Scores [ Time Frame: Baseline, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6) ] [ Designated as safety issue: No ]
- Number of Subjects With > = 5 New PWC Symptoms [ Time Frame: Baseline, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6) ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Physician's Withdrawal Checklist (PWC) Scores [ Time Frame: Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6) ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale Scores. [ Time Frame: Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 ) ] [ Designated as safety issue: No ]
- Mean Scores for Clinical Global Impression-Improvement (CGI-I) Scale [ Time Frame: Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 ) ] [ Designated as safety issue: No ]
- Mean Scores for Patient Global Impression-Improvement (PGI-I) [ Time Frame: Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 ) ] [ Designated as safety issue: No ]
- Mean Change From Baseline in Digit Symbol Substitution Test (DSST) Scores [ Time Frame: Baseline, Endpoint (AF Week 6 ) ] [ Designated as safety issue: No ]
- Time to Discontinuation [ Time Frame: Baseline, Week 13 (Final Visit/Early Termination) ] [ Designated as safety issue: Yes ]
- Time to First Use of Rescue Medication [ Time Frame: Baseline, Week 13 (Final Visit/Early Termination) ] [ Designated as safety issue: Yes ]
- Number of Subjects in Relapse Free State at 6-week Benzodiazepine-free Endpoint (Alprazolam Free Week 6) [ Time Frame: Alprazolam Free Week 6 ] [ Designated as safety issue: No ]
| Enrollment: | 108 |
| Study Start Date: | September 2006 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Pregabalin
Pregabalin treatment for GAD during 6 week taper/discontinuation from alprazolam treatment; followed by 6 weeks pregabalin treatment 'alprazolam free'.
|
Drug: Pregabalin
GAD subjects on stable dose of alprazolam will be randomized to double-blind pregabalin at starting dose of 75mg twice daily. Weekly assessments of tolerability, need for rescue medication, anxiety/withdrawal symptoms will guide flexible dose titration of pregabalin at dose range between 75 and 300mg twice daily. Subjects successful in discontinuation of alprazolam while treated with pregabalin will continue to be maintained on pregabalin for 6 weeks and assessed weekly for ability to remain in the study.
Other Name: Lyrica
|
|
Placebo Comparator: Placebo
Placebo treatment of GAD during 6 week taper/discontinuation of alprazolam treatment followed by 6 weeks continuation of placebo treatment 'alprazolam free'.
|
Drug: Placebo
GAD subjects on stable dose of alprazolam will be randomized to double-blind placebo matching assessments and study medication titration as detailed under the pregabalin arm description. Subjects successful in discontinuation of alprazolam while treated with placebo will continue to be maintained on placebo for 6 weeks and assessed weekly for ability to remain in the study.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00368745
Locations
| Costa Rica | |
| Pfizer Investigational Site | |
| San Pedro de Montes de Oca, San José, Costa Rica, 00 | |
| Czech Republic | |
| Pfizer Investigational Site | |
| Plzen, Czech Republic, 301 00 | |
| Pfizer Investigational Site | |
| Praha 10, Czech Republic, 100 00 | |
| Pfizer Investigational Site | |
| Praha 6, Czech Republic, 163 00 | |
| Pfizer Investigational Site | |
| Praha 7, Czech Republic, 170 00 | |
| Pfizer Investigational Site | |
| Praha-Bubenec, Czech Republic, 170 00 | |
| France | |
| Pfizer Investigational Site | |
| Paris, Cedex 12, France, 75571 | |
| Pfizer Investigational Site | |
| Arcachon, France, 33120 | |
| Pfizer Investigational Site | |
| Caen, France, 14000 | |
| Pfizer Investigational Site | |
| Elancourt, France, 78990 | |
| Pfizer Investigational Site | |
| Nantes-Orvault, France, 44700 | |
| Guatemala | |
| Pfizer Investigational Site | |
| Guatemala, Guatemala | |
| Italy | |
| Pfizer Investigational Site | |
| L'Aquila, Italy, 67100 | |
| Pfizer Investigational Site | |
| Milan, Italy, 20157 | |
| Mexico | |
| Pfizer Investigational Site | |
| Tepic, Nayarit, Mexico, 63000 | |
| Pfizer Investigational Site | |
| Mexico D.f., Mexico, 03740 | |
| Pfizer Investigational Site | |
| San Luis Potosi, Mexico, 78216 | |
| Spain | |
| Pfizer Investigational Site | |
| Langreo, Asturias, Spain, 33900 | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08036 | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08025 | |
| Pfizer Investigational Site | |
| Zamora, Spain, 49021 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00368745 History of Changes |
| Other Study ID Numbers: | A0081092 |
| Study First Received: | August 23, 2006 |
| Results First Received: | August 10, 2009 |
| Last Updated: | November 9, 2009 |
| Health Authority: | Mexico: Secretaria de Salud de Mexico |
Additional relevant MeSH terms:
|
Anxiety Disorders Mental Disorders Alprazolam Pregabalin Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anti-Anxiety Agents |
Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Peripheral Nervous System Agents Anticonvulsants |
ClinicalTrials.gov processed this record on June 18, 2013