NCT00534599 is a Phase 3 clinical trial of quetiapine fumarate XR in Anxiety, sponsored by AstraZeneca.

Who is sponsoring NCT00534599?

NCT00534599 is sponsored by AstraZeneca.

What drugs are being tested in NCT00534599?

Interventions in NCT00534599: Placebo, quetiapine fumarate XR.

What condition does NCT00534599 study?

NCT00534599 studies Anxiety, Anxiety Disorders, Anxiety Neuroses, Anxiety States.

Is NCT00534599 still recruiting?

NCT00534599 is currently completed. Last updated 12 April 2011.

Are results published for NCT00534599?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2011-04-12 · How we verify

NCT00534599

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Multicenter, Rand., Double-blind, Parallel-group, Pbo-controlled Study of the Efficacy and Safety of SEROQUEL® XR Compared With Pbo as an Adjunct to Treatment in Patients With Generalized Anxiety Disorder Who Demonstrate Partial or No Response to a SSRI or SNRI Alone or in Combination With a Benzo

Completed Phase 3 Results posted Last updated 12 April 2011

What this trial tests

Phase 3 trial testing Placebo in Anxiety in 409 participants. Completed in 1 September 2008.

Timeline

1 August 2007

Primary endpoint
1 September 2008

1 September 2008

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	409
Start date	1 August 2007
Primary completion	1 September 2008
Estimated completion	1 September 2008
Sites	53 locations across United States

Drugs / interventions tested

Placebo
quetiapine fumarate XR

Conditions studied

Anxiety — all drugs for Anxiety →
Anxiety Disorders — all drugs for Anxiety Disorders →
Anxiety Neuroses — all drugs for Anxiety Neuroses →
Anxiety States — all drugs for Anxiety States →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 65, any sex, with Anxiety or Anxiety Disorders. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score
Time frame: Baseline (randomization) and then 8 weeks
Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe). Results based on MITT population with available data for this outcome measure. Least square mean of each treatment was adjusted for baseline value.

Sponsor's own description

This study is being carried out to see if extended release quetiapine fumarate (Seroquel®XL) when added to standard selective serotonin reuptake inhibitor (SSRI) / serotonin-norepinephrine reuptake inhibitor (SNRI) therapy is effective and safe for the treatment of Generalized Anxiety Disorder in patients with partial or no response to SSRI/SNRI alone or in combination with a benzodiazepine, and if so, how it compares with placebo

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Anxiety disorders, PTSD and OCD: systematic review of approved psychiatric medications (2008-2024) and pipeline phase III medications.
Tadros E, Keerthana S, Padder S, Totlani J, et al · · 2025 · cited 3× · PMID 40225810 · DOI 10.7573/dic.2024-11-2
Extended Release Quetiapine Fumarate (Quetiapine XR) as Adjunct Therapy in Patients with Generalized Anxiety Disorder and a History of Inadequate Treatment Response: A Randomized, Double-Blind Study.
Khan A, Atkinson S, Mezhebovsky I, She F, et al · · 2011 · cited 2× · PMID 27738353 · DOI 10.64719/pb.4062

Verify or expand the search:

Other recruiting trials for Anxiety

Currently open trials in the same condition.

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Other AstraZeneca trials

Trials by the same sponsor.

NCT06998095 — Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea · not yet recruiting
NCT07431775 — Saphnelo Use in Females of Child-bearing Potential · not yet recruiting
NCT07516184 — Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis · NA · not yet recruiting
NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec · Phase 4 · not yet recruiting
NCT07279948 — A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort o · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00534599 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 12 April 2011

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00534599.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing