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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:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00368745
First received: August 23, 2006
Last updated: November 9, 2009
Last verified: November 2009

August 23, 2006
November 9, 2009
September 2006
August 2008   (final data collection date for primary outcome measure)
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 ]
  • Efficacy/Safety: The primary endpoint of this study is the proportion of subjects who are free of benzodiazepine and other psychoactive drugs during the six weeks of the Alprazolam-Free Phase of Double-Blind Treatment.
  • Being free of benzodiazepine and/or other psychoactive drugs is defined as:
  • Negative urine benzodiazepine/psychoactive toxicology assay (done at each visit of the Alprazolam-Free Phase of Double-Blind Treatment) and negative serum benzodiazepine/alcohol assay (done at endpoint).
Complete list of historical versions of study NCT00368745 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Mean change from randomization baseline to each visit in HAM-A scores
  • Mean change from randomization baseline to each visit in PWC scores
  • Proportion of subjects with > 6 point increase in PWC scores
  • Proportion of subjects with > 5 new PWC symptoms
  • Relapse free state at 6-week benzodiazepine-free endpoint
  • Mean PGI-I score at each visit.
  • Mean change from randomization baseline to each visit in CGI-S score
  • Mean CGI-I score at each visit.
  • Time until first “rescue medication”
  • Time until discontinuation
  • Mean change from randomization baseline to each visit in DSST scores
Not Provided
Not Provided
 
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.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Pregabalin in Subjects With Generalized Anxiety Disorder (GAD) Switching From Benzodiazepine Therapy.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Generalized Anxiety Disorder
  • 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
  • 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.
  • Active Comparator: Pregabalin
    Pregabalin treatment for GAD during 6 week taper/discontinuation from alprazolam treatment; followed by 6 weeks pregabalin treatment 'alprazolam free'.
    Intervention: Drug: Pregabalin
  • 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'.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
August 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Costa Rica,   Czech Republic,   France,   Guatemala,   Italy,   Mexico,   Spain
 
NCT00368745
A0081092
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP