drugset / Trial / NCT00534599

Generalized Anxiety Disorder Adjunct Study

NCT00534599 ↗

Phase 3 Completed 409 enrolled AstraZeneca
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start
2007-08
Primary completion
2008-09
Completion
2008-09

Outcome

Missed primary endpoint

paper The week 8 mean change in HAM-A total score was not statistically significant for quetiapine XR (–10.74; P=.079) vs placebo (–9.61). PMID 24660224 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Quetiapine Small molecule — Oral