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 | Completed Phase 3 Results

• 1 other identifier: A0081092
• Study Type: interventional
• Target: 108
• Locations: 7 countries
• Sites: 21

Brief 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.

Conditions

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• 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

  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).

  Endpoint (Post Alprazolam Free Week 6 or LOCF Post Alprazolam Free Week 1)

Secondary Outcomes (11)

• 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)

• 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)

• Number of Subjects With > = 5 New PWC Symptoms

  Baseline, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6)

• 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)

• 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 )

Study Arms (2)

Pregabalin

ACTIVE COMPARATOR

Pregabalin treatment for GAD during 6 week taper/discontinuation from alprazolam treatment; followed by 6 weeks pregabalin treatment 'alprazolam free'.

Drug: Pregabalin

Placebo

PLACEBO COMPARATOR

Placebo treatment of GAD during 6 week taper/discontinuation of alprazolam treatment followed by 6 weeks continuation of placebo treatment 'alprazolam free'.

Drug: Placebo

Interventions

Pregabalin DRUG

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.

Also known as: Lyrica

Pregabalin

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent
• years old
• male and female
• A primary lifetime diagnosis of DSM-IV-TR (2000) GAD (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (21)

Pfizer Investigational Site

San Pedro, Provincia de San José, 00, Costa Rica

Location

Pfizer Investigational Site

Pilsen, 301 00, Czechia

Location

Pfizer Investigational Site

Prague, 100 00, Czechia

Location

Pfizer Investigational Site

Prague, 163 00, Czechia

Location

Pfizer Investigational Site

Prague, 170 00, Czechia

Location

Pfizer Investigational Site

Praha-Bubenec, 170 00, Czechia

Location

Pfizer Investigational Site

Paris, Cedex 12, 75571, France

Location

Pfizer Investigational Site

Arcachon, 33120, France

Location

Pfizer Investigational Site

Caen, 14000, France

Location

Pfizer Investigational Site

Élancourt, 78990, France

Location

Pfizer Investigational Site

Nantes-Orvault, 44700, France

Location

Pfizer Investigational Site

Guatemala City, Guatemala

Location

Pfizer Investigational Site

L’Aquila, 67100, Italy

Location

Pfizer Investigational Site

Milan, 20157, Italy

Location

Pfizer Investigational Site

Tepic, Nayarit, 63000, Mexico

Location

Pfizer Investigational Site

Mexico City, 03740, Mexico

Location

Pfizer Investigational Site

San Luis Potosí City, 78216, Mexico

Location

Pfizer Investigational Site

Langreo, Principality of Asturias, 33900, Spain

Location

Pfizer Investigational Site

Barcelona, 08025, Spain

Location

Pfizer Investigational Site

Barcelona, 08036, Spain

Location

Pfizer Investigational Site

Zamora, 49021, Spain

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2006
• First Posted: August 25, 2006
• Study Start: September 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: February 9, 2021
• Results First Posted: November 9, 2009

Record last verified: 2009-11

Locations

CO (1); FR (5); CZ (5); GU (1); ME (3); ES (4); IT (2)