Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo and Active Control in Major Depressive Disorder

Overview

This study is to evaluate that (SEROQUEL®) quetiapine sustained-release is efficacious and safe in the treatment of patients with MDD.

Full Title of Study: “A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled and Active-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained-Release (SEROQUEL®) as Monotherapy in the Treatment of Patients With MDD”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double

Interventions

  • Drug: Quetiapine fumarate
  • Drug: Duloxetine

Clinical Trial Outcome Measures

Primary Measures

  • Change from randomization to Week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score

Secondary Measures

  • Change from randomization to each assessment in the MADRS total score
  • MADRS response, defined as a ≥50% reduction from randomization in the MADRS total score at Week 6

Participating in This Clinical Trial

Inclusion Criteria

  • Patient has a documented clinical diagnosis of Major Depressive 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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Overall Official(s)
    • Art Lazarus, MD, Study Director, AstraZeneca

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