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Quetiapine Extended Release (XR) Treatment of Major Depressive Disorder With Comorbid Generalized Anxiety Disorder

NCT00868374 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2016-12-29

Study results available
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Summary

The primary objective is to test the hypothesis that quetiapine XR (Extended Release) monotherapy or adjunctive therapy to antidepressant is superior to placebo monotherapy or placebo adjunctive therapy to antidepressant(s) in the acute treatment of depression symptoms in patients with MDD and comorbid GAD. The secondary objectives are to test the hypotheses that quetiapine XR is superior to placebo in the reduction of anxiety symptoms in patients with major depressive disorder and comorbid generalized anxiety disorder, the improvement of the quality of sleep in patients with major depressive disorder and comorbid generalized anxiety disorder and the improvement of the quality of life in patients with major depressive disorder and comorbid generalized anxiety disorder.

Conditions

Interventions

DRUG

Quetiapine XR

Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day

DRUG

Placebo

Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Keming Gao

    lead OTHER

Principal Investigators

  • Keming Gao, MD, PhD · University Hospitals Cleveland Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT00868374 on ClinicalTrials.gov