Comparison of Pregabalin Versus Venlafaxine XR and Placebo in the Treatment of Generalized Anxiety Disorder

An 8-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled, Flexible Dose Study Of Pregabalin (300-600 Mg/Day) And Venlafaxine XR (75-225 Mg/Day) For The Acute Treatment Of DSM-IV Generalized Anxiety Disorder In Outpatients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00151450

Enrollment

390

Registered

2005-09-09

Start date

2005-03-31

Completion date

2006-11-30

Last updated

2021-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Brief summary

The purpose of the study is to compare pregabalin to Venlafaxine XR and placebo in the treatment of generalized anxiety disorder.

Interventions

DRUGPregabalin

DRUGVenlafaxine XR

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Male and female outpatients with diagnosis of generalized anxiety disorder.

Exclusion criteria

* Any serious or uncontrolled medical condition. * Current diagnosis of depression, dysthymia, obsessive-compulsive disorder.

Design outcomes

Primary

Measure	Time frame
Evaluation of the efficacy of pregabalin and Venlafaxine XR in the treatment of generalized anxiety disorder.	—

Countries

Belgium, Canada, France, Ireland, Italy, Netherlands, Spain, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026