Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo & Active Control in Generalized Anxiety Disorder

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Controlled Study of the Efficacy and Safety of Sustained-Release Quetiapine Fumarate (SEROQUEL®) Compared With Placebo in the Treatment of Generalized Anxiety Disorder

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00329446

Acronym

GOLD

Enrollment

800

Registered

2006-05-24

Start date

2006-04-30

Completion date

2007-09-30

Last updated

2009-03-25

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

Conditions

Generalized Anxiety Disorder

Keywords

GAD, anxiety

Brief summary

The purpose of this study is to demonstrate that quetiapine SR (SEROQUEL®) is efficacious and safe in the acute treatment of patients with Generalized Anxiety Disorder. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Interventions

DRUGQuetiapine Fumarate

DRUGEscitalopram oxylate

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

* Patient has a documented clinical diagnosis of Generalized Anxiety Disorder. * Be able to understand and comply with the requirements of the study. * Able to understand and provide written informed consent

Exclusion criteria

* Patients (female) must not be pregnant or lactating * Current or past diagnosis of stroke or transient ischemic attack (TIA).

Design outcomes

Primary

Measure	Time frame
Change from randomization in the HAM-A total score at Day 57	—

Secondary

Measure	Time frame
Change from randomization in CGI-S score at Day 57	—

Countries

United States

Outcome results

None listed

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