MedTrace Logo

Pregabalin in the Treatment of Patients With Generalized Anxiety Disorder (GAD).

NCT00413010 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 356

Last updated 2021-02-10

Study results available
· View outcomes & findings →

Summary

The primary objective of this study is to evaluate the efficacy of pregabalin as compared to placebo in the treatment of patients with general anxiety disorder (GAD). Efficacy will be measured by the improvement in the total Hamilton Anxiety Rating Scale (HAM-A) scores from baseline observed following 8 weeks of double-blind treatment or at earlier termination during the double-blind treatment phase and analyzed using a mixed linear model for repeated measures.

Conditions

  • Generalized Anxiety Disorder

Interventions

DRUG

pregabalin

pregabalin 150-600 mg/day flexibly dosed for the first 6 weeks and fixed dosed for the last 2 weeks of total 8 weeks of double blind study period, + concurrent GAD treatment from the open-label study period

DRUG

placebo

placebo + concurrent GAD treatment from the open-label study period

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2008-02-29
Completion
2008-03-31

Countries

  • United States
  • Czechia
  • Estonia
  • Finland
  • Hungary
  • Russia
  • Serbia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00413010 on ClinicalTrials.gov